A Study to Learn About the Study Medicine Called CTB+AVP... | NCT05554237 | Trialant
NCT05554237
Sponsor
Pfizer
Status
Completed
Last Update Posted
Oct 10, 2024Actual
Enrollment
42Actual
Phase
Phase 1
Conditions
Healthy
Interventions
Placebo
PF-07612577
PF-06264006
Countries
Belgium
Protocol Section
Identification Module
NCT ID
Results Section
Participant Flow Module
Pre-assignment Details
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Derived Section
Miscellaneous Info Module
Version Holder
NCT05554237
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
C4691001
Secondary IDs
ID
Type
Description
Link
2021-005428-39
EudraCT Number
Brief Title
A Study to Learn About the Study Medicine Called CTB+AVP in Healthy Adult People.
Official Title
A PHASE 1, RANDOMIZED, DOUBLE-BLIND, SPONSOR-OPEN, PLACEBO-CONTROLLED, SINGLE AND MULTIPLE-DOSE STUDY TO EVALUATE THE SAFETY, TOLERABILITY AND PHARMACOKINETICS OF PF-07612577 (PF-06264006 [CTB] + PF-07338233 [AVP]) IN HEALTHY ADULT PARTICIPANTS
Acronym
Not provided
Organization
PfizerINDUSTRY
Status Module
Record Verification Date
Jun 2024
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Oct 7, 2022Actual
Primary Completion Date
Jun 23, 2023Actual
Completion Date
Jun 23, 2023Actual
First Submitted Date
Sep 21, 2022
First Submission Date that Met QC Criteria
Sep 21, 2022
First Posted Date
Sep 26, 2022Actual
Results Waived
Not provided
Results First Submitted Date
Jun 20, 2024
Results First Submitted that Met QC Criteria
Jun 20, 2024
Results First Posted Date
Oct 10, 2024Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Jun 20, 2024
Last Update Posted Date
Oct 10, 2024Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
PfizerINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
No
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The purpose of this clinical trial is to learn about the pharmacokinetics, safety and tolerability of various single- and multiple-doses of CTB+AVP in healthy adult participants. CTB+AVP is a study medicine that is being developed to treat people with complicated urinary tract infections.
This study is seeking healthy adult male and female participants, 18-60 years of age, with a body weight > 50 kg and a BMI of 17.5 to 30.5 kg/m2.
Participants in Part-1 of the study will receive increasing single doses of CTB and/or AVP. Participants in Part-2 will receive increasing multiple doses of CTB+AVP three times a day for 7 days. The study team will monitor how each participant is doing with the study treatments via close monitoring in an in-patient setting. Experiences of people receiving CTB+AVP will be compared to those of people who do not. This will help determine if CTB+AVP is safe and well-tolerated at each dose of the study medicine.
Participants will take part in this study for a maximum of 12 weeks for Part-1 (up to 4 weeks for screening, up to 3 weeks of taking study medicine and up to 5 weeks for safety follow-up visit) and for a maximum of 10 weeks for Part-2 (up to 4 weeks for screening, up to 1 week of taking study medicine and up to 5 weeks for safety follow-up visit). During the duration of the study, blood samples for study medicine levels, and various measures for monitoring safety such as blood samples for clinical laboratory measurements, electrocardiograms and vital sign measurements will be taken.
Detailed Description
This is a 2-part study in healthy male and female adult participants.
Part-1 is to evaluate safety, tolerability and pharmacokinetics (PK) of 3 planned and 2 optional doses in 8 participants, in a 5-period sequential single dose design.
Part-2 is to evaluate safety, tolerability and PK of 1 planned and 2 optional cohorts in 8 participants each, in a multiple dose sequential design, with 7 days of repeated every 8 hours (q8h) dosing in each cohort. In addition, 2 optional cohorts in 6 participants each of Japanese descent and Chinese descent will also receive multiple doses of CTB+AVP repeated every 8 hours (q8h) for 7 days.
Maximum Observed Concentration (Cmax) of Cis-Ceftibuten (CTB): Part 1
pre-dose,0.5,1,1.5,2,2.5,3,4,6,8,12,14 and 24 hours post dose
Time for Cmax (Tmax) of CTB: Part 1
pre-dose,0.5,1,1.5,2,2.5,3,4,6,8,12,14 and 24 hours post dose
Area Under the Plasma Concentration Time Curve From Time Zero to the Time of Last Quantifiable Concentration (AUClast) of CTB: Part 1
AUClast was determined using the linear/log trapezoidal method.
pre-dose,0.5,1,1.5,2,2.5,3,4,6,8,12,14 and 24 hours post dose
Dose-Normalized Cmax (Cmax[dn]) of CTB: Part 1
Dose-normalized Cmax was determined as Cmax/Dose.
pre-dose,0.5,1,1.5,2,2.5,3,4,6,8,12,14 and 24 hours post dose
Dose-Normalized AUClast (AUClast[dn]) of CTB: Part 1
AUClast(dn) was determined as AUClast/Dose.
pre-dose,0.5,1,1.5,2,2.5,3,4,6,8,12,14 and 24 hours post dose
Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUCinf) of CTB: Part 1
AUCinf was calculated as AUClast + (Clast/kel), where Clast is the predicted plasma concentration at the last quantifiable time point from the log-linear regression analysis.
pre-dose,0.5,1,1.5,2,2.5,3,4,6,8,12,14 and 24 hours post dose
Dose-Normalized AUCinf (AUCinf[dn]) of CTB: Part 1
AUCinf(dn) was calculated as AUCinf/Dose.
Secondary Outcomes
Measure
Description
Time Frame
Amount Excreted in Urine as Unchanged Drug Over the Dosing Interval Tau (Aetau) of Cis-CTB, Trans-CTB, AVP, AVI and HPA: Part 2
anytime between 0 to 8 hours post dose on Day 6
Percent of Dose Excreted in Urine as Unchanged Drug Over the Dosing Interval Tau (Aetau%) of Cis-CTB, Trans-CTB, AVP, AVI and HPA: Part 2
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
BMI of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lb)
For optional Japanese cohort only: Japanese participants who have 4 Japanese biologic grandparents who were born in Japan
For optional Chinese cohort only: Chinese participants who were born in mainland China, and both parents are of Chinese descent.
Exclusion Criteria:
Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing)
Known allergy to the cephalosporin group of antibiotics
History of HIV infection, hepatitis B, or hepatitis C; positive testing for HIV, HBsAg, or HCVAb. Hepatitis B vaccination is allowed
Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality [or other conditions or situations related to COVID-19 pandemic (eg, Contact with positive case, residence, or travel to an area with high incidence)] that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study
A positive urine drug test
Positive test result for SARS-CoV-2 infection at the time of screening or Day -1
Accepts Healthy Volunteers
Yes
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
60 Years
Standard Ages
Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Pfizer CT.gov Call Center
Pfizer
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Pfizer Clinical Research Unit - Brussels
Brussels
Bruxelles-capitale, Région de
B-1070
Belgium
References Module
Citations
Not provided
See Also Links
Label
URL
To obtain contact information for a study center near you, click here.
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
Types
Not provided
Time Frame
Not provided
Access Criteria
Not provided
URL
Not provided
A total of 42 participants (8 in Part 1 and 34 in Part 2) were enrolled in the study. The study was conducted at 1 site in Belgium.
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
CTB400+AVP900mg/CTB 800+AVP1350 mg /CTB800mg/ CTB1200+AVP1350 mg/Placebo for CTB 1600mg(Part1)
Healthy participants were administered a single oral dose of ceftibuten(CTB) 400 milligrams (mg) along with Avibactam Prodrug (AVP) 900 mg on Day 1 of Period 1 followed by a single oral dose of CTB 800 mg along with AVP 1350 mg on Day 1 of Period 2. Participants received a single oral dose of CTB 800 mg alone on Day 1 of Period 3 followed by CTB 1200 mg with AVP 1350 mg and placebo for CTB 1600 mg orally on Day 1 of Period 4 and 5 respectively. There was a washout period of minimum 3 days between doses.
FG001
CTB400+AVP900mg /CTB800+AVP1350mg /CTB 800mg/Placebo for CTB1200+AVP1350 mg /CTB1600 mg(Part1)
Healthy participants were administered a single oral dose of CTB 400 mg along with AVP 900 mg on Day 1 of Period 1 followed by a single oral dose of CTB 800 mg along with AVP 1350 mg on Day 1 of Period 2. Participants received a single oral dose of CTB 800 mg alone on Day 1 of Period 3 followed by a placebo of CTB 1200 mg along with AVP 1350 mg and CTB 1600 mg orally on Day 1 of Period 4 and 5 respectively. There was a washout period of minimum 3 days between doses.
FG002
CTB400+AVP900mg/ Placebo for CTB800+AVP1350mg/ Placebo CTB800mg/ CTB1200+AVP1350mg/ CTB1600mg(Part1)
Healthy participants were administered a single oral dose of CTB 400 mg along with AVP 900 mg on Day 1 of Period 1 followed by a single oral dose of placebo for CTB 800 mg along with AVP 1350 mg on Day 1 of Period 2. Participants received a single oral dose of placebo for CTB 800 mg alone on Day 1 of Period 3 followed by CTB 1200 mg along with AVP 1350 mg and CTB 1600 mg orally on Day 1 of Period 4 and 5 respectively. There was a washout period of minimum 3 days between doses.
FG003
Placebo for CTB400+AVP900mg/ CTB 800+AVP1350mg/ CTB800mg/ CTB1200mg+AVP1350mg/ CTB1600mg(Part1)
Healthy participants were administered a single oral dose of placebo for CTB 400 mg along with AVP 900 mg on Day 1 of Period 1 followed by a single oral dose of CTB 800 mg along with AVP 1350 mg on Day 1 of Period 2. Participants received a single oral dose of CTB 800 mg alone on Day 1 of Period 3 followed by CTB 1200 mg along with AVP 1350 mg and CTB 1600 mg orally on Day 1 of Period 4 and 5 respectively. There was a washout period of minimum 3 days between doses.
FG004
CTB 400 mg + AVP 1350 mg q8h (Part-2)
Healthy participants were administered CTB 400 mg along with AVP 1350 mg once every 8 hours (q8h) in a fed state on Days 1 to 6 and in a fasted state on Day 7.
FG005
Placebo for CTB 400 mg + AVP 1350 mg q8h (Part-2)
Healthy participants were administered placebo for CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
FG006
CTB 800 mg + AVP 1350 mg q8h (Part-2)
Healthy participants were administered CTB 800 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
FG007
Placebo for CTB 800 mg + AVP 1350 mg q8h (Part-2)
Healthy participants were administered placebo for CTB 800 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
FG008
CTB 400 mg + AVP 900 mg q8h (Part-2)
Healthy participants were administered CTB 400 mg along with AVP 900 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
FG009
Placebo for CTB 400 mg + AVP 900 mg q8h (Part-2)
Healthy participants were administered placebo for CTB 400 mg along with AVP 900 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
FG010
CTB 400 mg + AVP 1350 mg q8h (Japanese) (Part-2)
Healthy Japanese participants were administered CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
Healthy Japanese participants were administered placebo for CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
FG012
CTB 400 mg + AVP 1350 mg q8h (Chinese) (Part-2)
Healthy Chinese participants were administered CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
Healthy Chinese participants were administered placebo for CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
Periods
Title
Milestones
Reasons Not Completed
Part 1: Period 1 Treatment (1 Day)
Type
Comment
Milestone Data
STARTED
FG0002 subjects
FG0012 subjects
FG0022 subjects
FG0032 subjects
FG004
COMPLETED
FG0002 subjects
FG0012 subjects
FG0022 subjects
FG0032 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Part 1: Period 1 Washout (3 Days)
Type
Comment
Milestone Data
STARTED
FG0002 subjects
FG0012 subjects
FG0022 subjects
FG003
Part 1: Period 2 Treatment (1 Day)
Type
Comment
Milestone Data
STARTED
FG0002 subjects
FG0012 subjects
FG0022 subjects
FG003
Part 1: Period 2 Washout (3 Days)
Type
Comment
Milestone Data
STARTED
FG0002 subjects
FG0012 subjects
FG0022 subjects
FG003
Part 1: Period 3 Treatment (1 Day)
Type
Comment
Milestone Data
STARTED
FG0002 subjects
FG0012 subjects
FG0022 subjects
FG003
Part 1: Period 3 Washout (3 Days)
Type
Comment
Milestone Data
STARTED
FG0002 subjects
FG0012 subjects
FG0022 subjects
FG003
Part 1: Period 4 Treatment (1 Day)
Type
Comment
Milestone Data
STARTED
FG0002 subjects
FG0012 subjects
FG0022 subjects
FG003
Part 1: Period 4 Washout (3 Days)
Type
Comment
Milestone Data
STARTED
FG0002 subjects
FG0012 subjects
FG0022 subjects
FG003
Part 1: Period 5 Treatment (1 Day)
Type
Comment
Milestone Data
STARTED
FG0002 subjects
FG0012 subjects
FG0022 subjects
FG003
Part 2 (7 Days)
Type
Comment
Milestone Data
STARTED
FG0000 subjectsNo participants were enrolled in Part 2.
FG0010 subjectsNo participants were enrolled in Part 2.
FG0020 subjectsNo participants were enrolled in Part 2.
FG003
Baseline Characteristics Module
Baseline Analysis Population Description
Full analysis set included all participants randomly assigned to study intervention and who take at least 1 dose of study intervention.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
CTB400+AVP900mg/CTB 800+AVP1350 mg /CTB800mg/ CTB1200+AVP1350 mg/Placebo for CTB 1600mg(Part1)
Healthy participants were administered a single oral dose of ceftibuten(CTB) 400 milligrams (mg) along with Avibactam Prodrug (AVP) 900 mg on Day 1 of Period 1 followed by a single oral dose of CTB 800 mg along with AVP 1350 mg on Day 1 of Period 2. Participants received a single oral dose of CTB 800 mg alone on Day 1 of Period 3 followed by CTB 1200 mg with AVP 1350 mg and placebo for CTB 1600 mg orally on Day 1 of Period 4 and 5 respectively. There was a washout period of minimum 3 days between doses.
Denominators
Units
Counts
Participants
BG000
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Customized
Count of Participants
Outcome Measures Module
Outcome Measures
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Maximum Observed Concentration (Cmax) of Cis-Ceftibuten (CTB): Part 1
Pharmacokinetic parameter set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest were reported for the given part of the study.
Posted
Geometric Mean
Geometric Coefficient of Variation
Nanogram per milliliter (ng/mL)
pre-dose,0.5,1,1.5,2,2.5,3,4,6,8,12,14 and 24 hours post dose
ID
Title
Description
OG000
CTB 400 mg + AVP 900 mg (Part-1)
Healthy participants were administered a single oral dose of CTB 400 mg along with a single oral dose of AVP 900 mg in any of the treatment periods.
OG001
CTB 800 mg + AVP 1350 mg (Part-1)
Adverse Events Module
Frequency Threshold
1
Time Frame
From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days for part 1 and 42 days for part 2)
Description
Not provided
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
CTB 400 mg + AVP 900 mg (Part-1)
Healthy participants were administered a single oral dose of CTB 400 mg along with a single oral dose of AVP 900 mg in any of the treatment periods.
Participant and investigator-blinded and sponsor-open design for Part-1 and Part-2.
Who Masked
ParticipantInvestigator
PF-07612577
Drug
PF-07612577
PF-07612577
CTB+AVP
PF-06264006
Drug
PF-06264006
PF-06264006
ceftibuten (CTB)
pre-dose,0.5,1,1.5,2,2.5,3,4,6,8,12,14 and 24 hours post dose
Terminal Half-Life (t1/2) of CTB: Part 1
T1/2 was calculated as loge(2)/kel, where kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.
pre-dose,0.5,1,1.5,2,2.5,3,4,6,8,12,14 and 24 hours post dose
Apparent Volume of Distribution (Vz/F) of CTB: Part 1
Vz/F was calculated as Dose/(AUCinf * kel) where kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.
pre-dose,0.5,1,1.5,2,2.5,3,4,6,8,12,14 and 24 hours post dose
Apparent Clearance (CL/F) of CTB: Part 1
CL/F was calculated as Dose/AUCinf.
pre-dose,0.5,1,1.5,2,2.5,3,4,6,8,12,14 and 24 hours post dose
Maximum Observed Concentration (Cmax) of AVP, Avibactam (AVI) and Hydroxy Pivalic Acid (HPA): Part 1
The lower limit of quantification for AVP was 1.0 ng/mL.
pre-dose,0.5,1,1.5,2,2.5,3,4,6,8,12,14 and 24 hours post dose
Dose-Normalized AUClast (AUClast[dn]) of AVP, AVI and HPA: Part 1
AUClast(dn) was determined as AUClast/Dose. The lower limit of quantification for AVP was 1.0 ng/mL.
pre-dose,0.5,1,1.5,2,2.5,3,4,6,8,12,14 and 24 hours post dose
Time for Cmax (Tmax) of AVP, AVI and HPA: Part 1
The lower limit of quantification for AVP was 1.0 ng/mL.
pre-dose,0.5,1,1.5,2,2.5,3,4,6,8,12,14 and 24 hours post dose
Dose-Normalized Cmax (Cmax[dn]) of AVP, AVI and HPA: Part 1
Dose-normalized Cmax was determined as Cmax/Dose. The lower limit of quantification for AVP was 1.0 ng/mL.
pre-dose,0.5,1,1.5,2,2.5,3,4,6,8,12,14 and 24 hours post dose
Area Under the Plasma Concentration Time Curve From Time Zero to the Time of Last Quantifiable Concentration (AUClast) of AVP, AVI and HPA: Part 1
AUClast was determined using the linear/log trapezoidal method. The lower limit of quantification for AVP was 1.0 ng/mL.
pre-dose,0.5,1,1.5,2,2.5,3,4,6,8,12,14 and 24 hours post dose
Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUCinf) of AVP, AVI and HPA: Part 1
AUCinf was calculated as AUClast + (Clast/kel), where Clast is the predicted plasma concentration at the last quantifiable time point from the log-linear regression analysis.
pre-dose,0.5,1,1.5,2,2.5,3,4,6,8,12,14 and 24 hours post dose
Dose-Normalized AUCinf (AUCinf[dn]) of AVP, AVI and HPA: Part 1
AUCinf(dn) was calculated as AUCinf/Dose.
pre-dose,0.5,1,1.5,2,2.5,3,4,6,8,12,14 and 24 hours post dose
Terminal Half-Life (t1/2) of AVP, AVI and HPA: Part 1
T1/2 was calculated as loge(2)/kel, where kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.
pre-dose,0.5,1,1.5,2,2.5,3,4,6,8,12,14 and 24 hours post dose
Apparent Volume of Distribution (Vz/F) of AVP, AVI and HPA : Part 1
Vz/F was calculated as Dose/(AUCinf * kel) where kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.
pre-dose,0.5,1,1.5,2,2.5,3,4,6,8,12,14 and 24 hours post dose
Apparent Clearance (CL/F) of AVP, AVI and HPA: Part 1
CL/F was calculated as Dose/AUCinf.
pre-dose,0.5,1,1.5,2,2.5,3,4,6,8,12,14 and 24 hours post dose
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Severe TEAEs and Related TEAEs: Part 1
An adverse event (AE) was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. TEAEs were are any untoward medical incidence in a participant during administered study intervention, whether or not these events are related to study intervention. Severe TEAEs were defined as type of AE that interrupted usual activities of daily life (ADL), or significantly affects clinical status, or may require intensive therapeutic intervention. Related TEAEs are defined as all TEAEs considered by the investigator to have at least a 'possible' relationship with the study intervention.
From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days)
Number of Participants With Withdrawals Due to TEAEs: Part 1
An AE was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. TEAEs were are any untoward medical incidence in a participant during administered study intervention, whether or not these events are related to study intervention.
From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days)
Number of Participants With Laboratory Test Abnormalities: Part 1
The laboratory abnormalities with non-zero participants were reported and it included: monocytes or leukocytes (greater than [>] 1.2* upper limit of normal [ULN]), urine hemoglobin scalar (greater than or equal to [>=1]) and leukocyte esterase scalar (>=1).
Up to 24 hours post-dose
Number of Participants With Clinically Significant Changes in Vital Signs Abnormalities: Part 1
Vital signs included blood pressure and pulse rate and were measured in a supine position after approximately 5 minutes of rest for the participant. Clinically significant changes in vital signs were determined by the investigator.
Up to 24 hours post-dose
Number of Participants With Electrocardiogram (ECG) Abnormalities: Part 1
Twelve lead ECGs were collected using an ECG machine that automatically calculated heart rate and measured PR interval, QRS duration, QT interval, QT interval correct by Bazzette's formula (QTcB) and QT interval correct by Frederica formula QTcF. ECG abnormalities included: PR interval aggregate (millisecond [msec], maximum [max.] >=300; baseline > 200 and max. increase >= 25 percent (%); baseline > 200 and max. increase >= 25%), QRS duration aggregate (msec, max >=140; max. increase >= 50%), QT interval aggregate (msec, value > 500), QTCB interval aggregate and QTCF interval aggregate (msec, 450 < max <= 480; 480 < max. <= 500; max. > 500; 30 < max. increase <= 60; max. increase > 60).
Up to 24 hours post-dose
Maximum Observed Concentration (Cmax) of Cis-CTB and Trans-CTB: Part 2
pre-dose,0.5,1,1.5,2,2.5,3,4,6 and 8 hours post dose on Day 1 and 6; pre-dose,0.5,1,1.5,2,2.5,3,4,6,8,12,16 and 24 hours post dose on Day 7
Time for Cmax (Tmax) of Cis-CTB and Trans-CTB: Part 2
pre-dose,0.5,1,1.5,2,2.5,3,4,6 and 8 hours post dose on Day 1 and 6; pre-dose,0.5,1,1.5,2,2.5,3,4,6,8,12,16 and 24 hours post dose on Day 7
Area Under the Plasma Concentration Time Curve From Time Zero to Time Tau, the Dosing Interval (AUCtau) of Cis-CTB and Trans-CTB: Part 2
Area under the plasma concentration time profile from time zero to time tau, the dosing interval, where tau is equal to 8 hours for three times daily (TID) dosing.
pre-dose,0.5,1,1.5,2,2.5,3,4,6 and 8 hours post dose on Day 1 and 6; pre-dose,0.5,1,1.5,2,2.5,3,4,6 and 8 hours post dose on Day 7
Dose-Normalized Cmax (Cmax[dn]) of Cis-CTB and Trans-CTB : Part 2
Dose-normalized Cmax was determined as Cmax/Dose.
pre-dose,0.5,1,1.5,2,2.5,3,4,6 and 8 hours post dose on Day 1 and 6; pre-dose,0.5,1,1.5,2,2.5,3,4,6,8,12,16 and 24 hours post dose on Day 7
Dose-Normalized AUCtau (AUCtau[dn]) of Cis-CTB and Trans-CTB: Part 2
Area under the plasma concentration time profile from time zero to time tau, the dosing interval, where tau is equal to 8 hours for three times daily (TID) dosing.
pre-dose,0.5,1,1.5,2,2.5,3,4,6 and 8 hours post dose on Day 1 and 6; pre-dose,0.5,1,1.5,2,2.5,3,4,6,8,12,16 and 24 hours post dose on Day 7
Terminal Half-Life (t1/2) of Cis-CTB and Trans-CTB on Day 7: Part 2
T1/2 was calculated as loge(2)/kel, where kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.
pre-dose,0.5,1,1.5,2,2.5,3,4,6,8,12,16 and 24 hours post dose on Day 7
Apparent Volume of Distribution (Vz/F) of Cis-CTB and Trans-CTB : Part 2
Vz/F was calculated as Dose/(AUCinf * kel) where kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.
pre-dose,0.5,1,1.5,2,2.5,3,4,6 and 8 hours post dose on Day 1 and 6; pre-dose,0.5,1,1.5,2,2.5,3,4,6,8,12,16 and 24 hours post dose on Day 7
Apparent Clearance (CL/F) of Cis-CTB and Trans-CTB: Part 2
CL/F was calculated as Dose/AUCinf.
pre-dose,0.5,1,1.5,2,2.5,3,4,6 and 8 hours post dose on Day 1 and 6; pre-dose,0.5,1,1.5,2,2.5,3,4,6,8,12,16 and 24 hours post dose on Day 7
Maximum Observed Concentration (Cmax) of AVP, AVI and HPA: Part 2
The lower limit of quantification for AVP was 1.0 ng/mL.
pre-dose,0.5,1,1.5,2,2.5,3,4,6 and 8 hours post dose on Day 1 and 6; pre-dose,0.5,1,1.5,2,2.5,3,4,6,8,12,16 and 24 hours post dose on Day 7
Area Under the Plasma Concentration Time Curve From Time Zero to Time Tau, the Dosing Interval (AUCtau) of AVP, AVI and HPA: Part 2
Area under the plasma concentration time profile from time zero to time tau, the dosing interval, where tau is equal to 8 hours for three times daily (TID) dosing.
pre-dose,0.5,1,1.5,2,2.5,3,4,6 and 8 hours post dose on Day 1 and 6; pre-dose,0.5,1,1.5,2,2.5,3,4,6 and 8 hours post dose on Day 7
Time for Cmax (Tmax) of AVP, AVI and HPA: Part 2
The lower limit of quantification for AVP was 1.0 ng/mL.
pre-dose,0.5,1,1.5,2,2.5,3,4,6 and 8 hours post dose on Day 1 and 6; pre-dose,0.5,1,1.5,2,2.5,3,4,6,8,12,16 and 24 hours post dose on Day 7
Dose-Normalized Cmax (Cmax[dn]) of AVP, AVI and HPA: Part 2
Dose-normalized Cmax was determined as Cmax/Dose. The lower limit of quantification for AVP was 1.0 ng/mL.
pre-dose,0.5,1,1.5,2,2.5,3,4,6 and 8 hours post dose on Day 1 and 6; pre-dose,0.5,1,1.5,2,2.5,3,4,6,8,12,16 and 24 hours post dose on Day 7
Dose-Normalized AUCtau (AUCtau[dn]) of AVP, AVI and HPA: Part 2
Area under the plasma concentration time profile from time zero to time tau, the dosing interval, where tau is equal to 8 hours for three times daily (TID) dosing.
pre-dose,0.5,1,1.5,2,2.5,3,4,6 and 8 hours post dose on Day 1 and 6; pre-dose,0.5,1,1.5,2,2.5,3,4,6,8,12,16 and 24 hours post dose on Day 7
Terminal Half-Life (t1/2) of AVP, AVI and HPA on Day 7: Part 2
T1/2 was calculated as loge(2)/kel, where kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. The lower limit of quantification for HPA was 10.0 ng/mL.
pre-dose,0.5,1,1.5,2,2.5,3,4,6,8,12,16 and 24 hours post dose on day 7
Apparent Volume of Distribution (Vz/F) of AVP, AVI and HPA: Part 2
Vz/F was calculated as Dose/(AUCinf * kel) where kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. The lower limit of quantification for AVI and HPA was 10.0 ng/mL.
pre-dose,0.5,1,1.5,2,2.5,3,4,6 and 8 hours post dose on Day 1 and 6; pre-dose,0.5,1,1.5,2,2.5,3,4,6,8,12,16 and 24 hours post dose on Day 7
Apparent Clearance (CL/F) of AVP, AVI and HPA: Part 2
CL/F was calculated as Dose/AUCinf.
pre-dose,0.5,1,1.5,2,2.5,3,4,6 and 8 hours post dose on Day 1 and 6; pre-dose,0.5,1,1.5,2,2.5,3,4,6,8,12,16 and 24 hours post dose on Day 7
Number of Participants With TEAEs, Severe TEAEs and Related TEAEs: Part 2
An AE was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. TEAEs were are any untoward medical incidence in a participant during administered study intervention, whether or not these events are related to study intervention. Severe TEAEs were defined as type of AE that interrupted usual ADL, or significantly affects clinical status, or may require intensive therapeutic intervention. Related TEAEs are defined as all TEAEs considered by the investigator to have at least a 'possible' relationship with the study intervention.
From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 42 days)
Number of Participants With Withdrawals Due to TEAEs: Part 2
An AE was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. TEAEs were any untoward medical incidence in a participant during administered study intervention, whether or not these events are related to study intervention.
From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 42 days)
Number of Participants With Laboratory Test Abnormalities: Part 2
The laboratory abnormalities with non-zero participants were reported and it included: neutrophils/ leukocytes (less than [<] 0.8x lower limit of normal [LLN]), eosinophils/leukocytes (>1.2x ULN), monocytes/leukocytes (>1.2x ULN), bicarbonate (>1.1x ULN), urine glucose (>=1), ketones scalar (>=1), urine hemoglobin scalar (>=1), leukocyte esterase scalar (>=1).
From start of treatment up to Day 7
Number of Participants With Clinically Significant Changes in Vital Signs Abnormalities: Part 2
Vital signs included blood pressure and pulse rate and were measured in a supine position after approximately 5 minutes of rest for the participant. Clinically significant changes in vital signs were determined by the investigator.
From start of treatment up to Day 7
Number of Participants With Electrocardiogram (ECG) Abnormalities: Part 2
Twelve lead ECGs were collected using an ECG machine that automatically calculated heart rate and measured PR interval, QRS duration, QT interval, QT interval correct by Bazzette's formula (QTcB) and QT interval correct by Frederica formula QTcF. ECG abnormalities included: PR interval aggregate (millisecond [msec], maximum [max.] >=300; baseline > 200 and max. increase >= 25 percent (%); baseline > 200 and max. increase >= 25%), QRS duration aggregate (msec, max >=140; max. increase >= 50%), QT interval aggregate (msec, value > 500), QTCB interval aggregate and QTCF interval aggregate (msec, 450 < max <= 480; 480 < max. <= 500; max. > 500; 30 < max. increase <= 60; max. increase > 60).
From start of treatment up to Day 7
Aetau% was calculated as 100*Aetau/Dose.
anytime between 0 to 8 hours post dose on Day 6
Renal Clearance (CLr) of Cis-CTB, Trans-CTBa, AVP, AVI and HPA: Part 2
Aetau% was calculated as 100*Aetau/Dose.
anytime between 0 to 8 hours post dose on Day 6
Maximum Observed Concentration (Cmax) of Cis-CTB, AVP, AVI and HPA in Japanese and Chinese Cohorts: Part 2
The lower limit of quantification for cis-CTB was 100.0 ng/mL, and for AVI and HPA was 10.0 ng/mL.
pre-dose,0.5,1,1.5,2,2.5,3,4,6 and 8 hours post dose on Day 1 and 6; pre-dose,0.5,1,1.5,2,2.5,3,4,6 and 8 hours post dose on Day 7
Time for Cmax (Tmax) of Cis-CTB, AVP, AVI and HPA in Japanese and Chinese Cohorts: Part 2
The lower limit of quantification for cis-CTB was 100.0 ng/mL, and for AVI and HPA was 10.0 ng/mL.
pre-dose,0.5,1,1.5,2,2.5,3,4,6 and 8 hours post dose on Day 1 and 6; pre-dose,0.5,1,1.5,2,2.5,3,4,6,8,12,16 and 24 hours post dose on Day 7
Area Under the Plasma Concentration Time Curve From Time Zero to Time Tau, the Dosing Interval (AUCtau) of Cis-CTB, AVP, AVI and HPA in Japanese and Chinese Cohorts: Part 2
Area under the plasma concentration time profile from time zero to time tau, the dosing interval, where tau is equal to 8 hours for TID dosing. The lower limit of quantification for cis-CTB was 100.0 ng/mL, and for AVI and HPA was 10.0 ng/mL.
pre-dose,0.5,1,1.5,2,2.5,3,4,6 and 8 hours post dose on Day 1 and 6; pre-dose,0.5,1,1.5,2,2.5,3,4,6 and 8 hours post dose on Day 7
Dose-Normalized Cmax (Cmax[dn]) of Cis-CTB, AVP, AVI and HPA in Japanese and Chinese Cohorts: Part 2
Dose-normalized Cmax was determined as Cmax/Dose. The lower limit of quantification for cis-CTB was 100.0 ng/mL, and for AVI and HPA was 10.0 ng/mL.
pre-dose,0.5,1,1.5,2,2.5,3,4,6 and 8 hours post dose on Day 1 and 6; pre-dose,0.5,1,1.5,2,2.5,3,4,6,8,12,16 and 24 hours post dose on Day 7
Dose-Normalized AUCtau (AUCtau[dn]) of Cis-CTB, AVP, AVI and HPA in Japanese and Chinese Cohorts: Part 2
Area under the plasma concentration time profile from time zero to time tau, the dosing interval, where tau is equal to 8 hours for TID dosing. The lower limit of quantification for cis-CTB was 100.0 ng/mL, and for AVI and HPA was 10.0 ng/mL.
pre-dose,0.5,1,1.5,2,2.5,3,4,6 and 8 hours post dose on Day 1 and 6; pre-dose,0.5,1,1.5,2,2.5,3,4,6 and 8 hours post dose on Day 7
Terminal Half-Life (t1/2) of Cis-CTB, AVP, AVI and HPA in Japanese and Chinese Cohorts: Part 2
T1/2 was calculated as loge(2)/kel, where kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. The lower limit of quantification for cis-CTB was 100.0 ng/mL, and for AVI and HPA was 10.0 ng/mL.
pre-dose,0.5,1,1.5,2,2.5,3,4,6 and 8 hours post dose on Day 1 and 6; pre-dose,0.5,1,1.5,2,2.5,3,4,6,8,12,16 and 24 hours post dose on Day 7
Apparent Volume of Distribution (Vz/F) of Cis-CTB, AVP, AVI and HPA in Japanese and Chinese Cohorts: Part 2
Vz/F was calculated as Dose/(AUCinf * kel) where kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. The lower limit of quantification for cis-CTB was 100.0 ng/mL, and for AVI and HPA was 10.0 ng/mL.
pre-dose,0.5,1,1.5,2,2.5,3,4,6 and 8 hours post dose on Day 1 and 6; pre-dose,0.5,1,1.5,2,2.5,3,4,6,8,12,16 and 24 hours post dose on Day 7
Apparent Clearance (CL/F) of Cis-CTB, AVP, AVI and HPA in Japanese and Chinese Cohorts: Part 2
CL/F was calculated as Dose/AUCinf. The lower limit of quantification for cis-CTB was 100.0 ng/mL, and for AVI and HPA was 10.0 ng/mL.
pre-dose,0.5,1,1.5,2,2.5,3,4,6 and 8 hours post dose on Day 1 and 6; pre-dose,0.5,1,1.5,2,2.5,3,4,6,8,12,16 and 24 hours post dose on Day 7
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No participants were enrolled in Part 2.
FG0046 subjectsParticipants enrolled in Part 2 of the study.
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Adverse Event
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BG001
CTB400+AVP900mg /CTB800+AVP1350mg /CTB 800mg/Placebo for CTB1200+AVP1350 mg /CTB1600 mg(Part1)
Healthy participants were administered a single oral dose of CTB 400 mg along with AVP 900 mg on Day 1 of Period 1 followed by a single oral dose of CTB 800 mg along with AVP 1350 mg on Day 1 of Period 2. Participants received a single oral dose of CTB 800 mg alone on Day 1 of Period 3 followed by a placebo of CTB 1200 mg along with AVP 1350 mg and CTB 1600 mg orally on Day 1 of Period 4 and 5 respectively. There was a washout period of minimum 3 days between doses.
BG002
CTB400+AVP900mg/ Placebo for CTB800+AVP1350mg/ Placebo CTB800mg/ CTB1200+AVP1350mg/ CTB1600mg(Part1)
Healthy participants were administered a single oral dose of CTB 400 mg along with AVP 900 mg on Day 1 of Period 1 followed by a single oral dose of placebo for CTB 800 mg along with AVP 1350 mg on Day 1 of Period 2. Participants received a single oral dose of placebo for CTB 800 mg alone on Day 1 of Period 3 followed by CTB 1200 mg along with AVP 1350 mg and CTB 1600 mg orally on Day 1 of Period 4 and 5 respectively. There was a washout period of minimum 3 days between doses.
BG003
Placebo for CTB400+AVP900mg/ CTB 800+AVP1350mg/ CTB800mg/ CTB1200mg+AVP1350mg/ CTB1600mg(Part1)
Healthy participants were administered a single oral dose of placebo for CTB 400 mg along with AVP 900 mg on Day 1 of Period 1 followed by a single oral dose of CTB 800 mg along with AVP 1350 mg on Day 1 of Period 2. Participants received a single oral dose of CTB 800 mg alone on Day 1 of Period 3 followed by CTB 1200 mg along with AVP 1350 mg and CTB 1600 mg orally on Day 1 of Period 4 and 5 respectively. There was a washout period of minimum 3 days between doses.
BG004
CTB 400 mg + AVP 1350 mg q8h (Part-2)
Healthy participants were administered CTB 400 mg along with AVP 1350 mg once every 8 hours (q8h) in a fed state on Days 1 to 6 and in a fasted state on Day 7.
BG005
Placebo for CTB 400 mg + AVP 1350 mg q8h (Part-2)
Healthy participants were administered placebo for CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
BG006
CTB 800 mg + AVP 1350 mg q8h (Part-2)
Healthy participants were administered CTB 800 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
BG007
Placebo for CTB 800 mg + AVP 1350 mg q8h (Part-2)
Healthy participants were administered placebo for CTB 800 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
BG008
CTB 400 mg + AVP 900 mg q8h (Part-2)
Healthy participants were administered CTB 400 mg along with AVP 900 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
BG009
Placebo for CTB 400 mg + AVP 900 mg q8h (Part-2)
Healthy participants were administered placebo for CTB 400 mg along with AVP 900 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
BG010
CTB 400 mg + AVP 1350 mg q8h (Japanese) (Part-2)
Healthy Japanese participants were administered CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
Healthy Japanese participants were administered placebo for CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
BG012
CTB 400 mg + AVP 1350 mg q8h (Chinese) (Part-2)
Healthy Chinese participants were administered CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
Healthy Chinese participants were administered placebo for CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
BG014
Total
Total of all reporting groups
2
BG0012
BG0022
BG0032
BG0046
BG0052
BG0066
BG0072
BG0086
BG0092
BG0105
BG0111
BG0123
BG0131
BG01442
Participants
Title
Denominators
Categories
Title
Measurements
18-44 Years
BG0002
BG0012
BG0021
BG0032
BG0042
BG0051
BG0066
BG0072
BG0084
BG0092
BG0104
BG0110
BG0122
BG0130
BG01430
45-64 Years
BG0000
BG0010
BG0021
BG0030
BG004
Not disclosed
BG0000
BG0010
BG0020
BG0030
BG004
Sex/Gender, Customized
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0001
BG0010
BG0020
BG0031
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
BG0110
BG0121
BG0130
BG0143
Male
BG0001
BG0012
BG0022
BG0031
BG004
Not disclosed
BG0000
BG0010
BG0020
BG0030
BG004
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
White
BG0002
BG0012
BG0022
BG0032
BG0046
BG0052
BG0064
BG0072
BG0086
BG0092
BG0100
BG0110
BG0120
BG0130
BG01430
Black or African American
BG0000
BG0010
BG0020
BG0030
BG004
Asian
BG0000
BG0010
BG0020
BG0030
BG004
Not disclosed
BG0000
BG0010
BG0020
BG0030
BG004
Healthy participants were administered a single oral dose of CTB 800 mg along with a single oral dose of AVP 1350 mg in any of the treatment periods.
OG002
CTB 800 mg (Part-1)
Healthy participants were administered a single oral dose of CTB 800 mg in any of the treatment periods.
OG003
CTB 1200 mg + AVP 1350 mg (Part-1)
Healthy participants were administered a single oral dose of CTB 1200 mg along with a single oral dose of AVP 1350 mg in any of the treatment periods.
OG004
CTB 1600 mg (Part-1)
Healthy participants were administered a single oral dose of CTB 1600 mg in any of the treatment periods.
Units
Counts
Participants
OG0006
OG0016
OG0026
OG0036
OG0046
Title
Denominators
Categories
Title
Measurements
OG00018170± 24
OG00125470± 18
OG00230510± 16
OG00327120± 12
OG00444990± 25
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG001
OG002
Ratio of adjusted geometric means
83.46
2-Sided
90
74.67
93.29
Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect (for CTB 800 mg + AVP 1350 mg versus CTB 800mg only)
Other
Primary
Time for Cmax (Tmax) of CTB: Part 1
Pharmacokinetic parameter set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest were reported for the given part of the study.
Posted
Median
Full Range
Hours
pre-dose,0.5,1,1.5,2,2.5,3,4,6,8,12,14 and 24 hours post dose
ID
Title
Description
OG000
CTB 400 mg + AVP 900 mg (Part-1)
Healthy participants were administered a single oral dose of CTB 400 mg along with a single oral dose of AVP 900 mg in any of the treatment periods.
OG001
CTB 800 mg + AVP 1350 mg (Part-1)
Healthy participants were administered a single oral dose of CTB 800 mg along with a single oral dose of AVP 1350 mg in any of the treatment periods.
OG002
CTB 800 mg (Part-1)
Healthy participants were administered a single oral dose of CTB 800 mg in any of the treatment periods.
OG003
CTB 1200 mg + AVP 1350 mg (Part-1)
Healthy participants were administered a single oral dose of CTB 1200 mg along with a single oral dose of AVP 1350 mg in any of the treatment periods.
OG004
CTB 1600 mg (Part-1)
Healthy participants were administered a single oral dose of CTB 1600 mg in any of the treatment periods.
Units
Counts
Participants
OG0006
OG0016
OG0026
OG003
Title
Denominators
Categories
Title
Measurements
OG0003.21(2.12 to 4.05)
OG0014.03(3.03 to 4.15)
OG0023.50(1.50 to 4.02)
OG003
Primary
Area Under the Plasma Concentration Time Curve From Time Zero to the Time of Last Quantifiable Concentration (AUClast) of CTB: Part 1
AUClast was determined using the linear/log trapezoidal method.
Pharmacokinetic parameter set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest were reported for the given part of the study.
Posted
Geometric Mean
Geometric Coefficient of Variation
Nanogram*hours per milliliter
pre-dose,0.5,1,1.5,2,2.5,3,4,6,8,12,14 and 24 hours post dose
ID
Title
Description
OG000
CTB 400 mg + AVP 900 mg (Part-1)
Healthy participants were administered a single oral dose of CTB 400 mg along with a single oral dose of AVP 900 mg in any of the treatment periods.
OG001
CTB 800 mg + AVP 1350 mg (Part-1)
Healthy participants were administered a single oral dose of CTB 800 mg along with a single oral dose of AVP 1350 mg in any of the treatment periods.
OG002
CTB 800 mg (Part-1)
Healthy participants were administered a single oral dose of CTB 800 mg in any of the treatment periods.
OG003
CTB 1200 mg + AVP 1350 mg (Part-1)
Healthy participants were administered a single oral dose of CTB 1200 mg along with a single oral dose of AVP 1350 mg in any of the treatment periods.
OG004
CTB 1600 mg (Part-1)
Healthy participants were administered a single oral dose of CTB 1600 mg in any of the treatment periods.
Units
Counts
Participants
OG0006
OG0016
OG0026
OG003
Title
Denominators
Categories
Title
Measurements
OG00094050± 18
OG001154100± 14
OG002171800± 15
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG001
OG002
Ratio of adjusted geometric means
89.70
2-Sided
90
87.24
92.23
Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect (for CTB 800 mg + AVP 1350 mg versus CTB 800mg only
Other
Primary
Dose-Normalized Cmax (Cmax[dn]) of CTB: Part 1
Dose-normalized Cmax was determined as Cmax/Dose.
Pharmacokinetic parameter set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest were reported for the given part of the study.
Posted
Geometric Mean
Geometric Coefficient of Variation
Nanogram per milliliter per milligram
pre-dose,0.5,1,1.5,2,2.5,3,4,6,8,12,14 and 24 hours post dose
ID
Title
Description
OG000
CTB 400 mg + AVP 900 mg (Part-1)
Healthy participants were administered a single oral dose of CTB 400 mg along with a single oral dose of AVP 900 mg in any of the treatment periods.
OG001
CTB 800 mg + AVP 1350 mg (Part-1)
Healthy participants were administered a single oral dose of CTB 800 mg along with a single oral dose of AVP 1350 mg in any of the treatment periods.
OG002
CTB 800 mg (Part-1)
Healthy participants were administered a single oral dose of CTB 800 mg in any of the treatment periods.
OG003
CTB 1200 mg + AVP 1350 mg (Part-1)
Healthy participants were administered a single oral dose of CTB 1200 mg along with a single oral dose of AVP 1350 mg in any of the treatment periods.
OG004
CTB 1600 mg (Part-1)
Healthy participants were administered a single oral dose of CTB 1600 mg in any of the treatment periods.
Units
Counts
Participants
OG0006
OG0016
OG0026
OG003
Title
Denominators
Categories
Title
Measurements
OG00045.45± 24
OG00131.83± 18
OG00238.16± 16
OG003
Primary
Dose-Normalized AUClast (AUClast[dn]) of CTB: Part 1
AUClast(dn) was determined as AUClast/Dose.
Pharmacokinetic parameter set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest were reported for the given part of the study.
Posted
Geometric Mean
Geometric Coefficient of Variation
Nanogram*hour/milliliter per milligram
pre-dose,0.5,1,1.5,2,2.5,3,4,6,8,12,14 and 24 hours post dose
ID
Title
Description
OG000
CTB 400 mg + AVP 900 mg (Part-1)
Healthy participants were administered a single oral dose of CTB 400 mg along with a single oral dose of AVP 900 mg in any of the treatment periods.
OG001
CTB 800 mg + AVP 1350 mg (Part-1)
Healthy participants were administered a single oral dose of CTB 800 mg along with a single oral dose of AVP 1350 mg in any of the treatment periods.
OG002
CTB 800 mg (Part-1)
Healthy participants were administered a single oral dose of CTB 800 mg in any of the treatment periods.
OG003
CTB 1200 mg + AVP 1350 mg (Part-1)
Healthy participants were administered a single oral dose of CTB 1200 mg along with a single oral dose of AVP 1350 mg in any of the treatment periods.
OG004
CTB 1600 mg (Part-1)
Healthy participants were administered a single oral dose of CTB 1600 mg in any of the treatment periods.
Units
Counts
Participants
OG0006
OG0016
OG0026
OG003
Title
Denominators
Categories
Title
Measurements
OG000235.2± 18
OG001192.9± 14
OG002214.9± 15
OG003
Primary
Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUCinf) of CTB: Part 1
AUCinf was calculated as AUClast + (Clast/kel), where Clast is the predicted plasma concentration at the last quantifiable time point from the log-linear regression analysis.
Pharmacokinetic parameter set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest were reported for the given part of the study.
Posted
Geometric Mean
Geometric Coefficient of Variation
Nanogram*hour per milliliter
pre-dose,0.5,1,1.5,2,2.5,3,4,6,8,12,14 and 24 hours post dose
ID
Title
Description
OG000
CTB 400 mg + AVP 900 mg (Part-1)
Healthy participants were administered a single oral dose of CTB 400 mg along with a single oral dose of AVP 900 mg in any of the treatment periods.
OG001
CTB 800 mg + AVP 1350 mg (Part-1)
Healthy participants were administered a single oral dose of CTB 800 mg along with a single oral dose of AVP 1350 mg in any of the treatment periods.
OG002
CTB 800 mg (Part-1)
Healthy participants were administered a single oral dose of CTB 800 mg in any of the treatment periods.
OG003
CTB 1200 mg + AVP 1350 mg (Part-1)
Healthy participants were administered a single oral dose of CTB 1200 mg along with a single oral dose of AVP 1350 mg in any of the treatment periods.
OG004
CTB 1600 mg (Part-1)
Healthy participants were administered a single oral dose of CTB 1600 mg in any of the treatment periods.
Units
Counts
Participants
OG0006
OG0016
OG0026
OG003
Title
Denominators
Categories
Title
Measurements
OG00094730± 18
OG001155800± 13
OG002173200± 14
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG001
OG002
Ratio of adjusted geometric means
89.91
2-Sided
90
87.47
92.41
Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect (for CTB 800 mg + AVP 1350 mg versus CTB 800mg only
Other
Primary
Dose-Normalized AUCinf (AUCinf[dn]) of CTB: Part 1
AUCinf(dn) was calculated as AUCinf/Dose.
Pharmacokinetic parameter set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest were reported for the given part of the study.
Posted
Geometric Mean
Geometric Coefficient of Variation
Nanogram*hour/milliliter per milligram
pre-dose,0.5,1,1.5,2,2.5,3,4,6,8,12,14 and 24 hours post dose
ID
Title
Description
OG000
CTB 400 mg + AVP 900 mg (Part-1)
Healthy participants were administered a single oral dose of CTB 400 mg along with a single oral dose of AVP 900 mg in any of the treatment periods.
OG001
CTB 800 mg + AVP 1350 mg (Part-1)
Healthy participants were administered a single oral dose of CTB 800 mg along with a single oral dose of AVP 1350 mg in any of the treatment periods.
OG002
CTB 800 mg (Part-1)
Healthy participants were administered a single oral dose of CTB 800 mg in any of the treatment periods.
OG003
CTB 1200 mg + AVP 1350 mg (Part-1)
Healthy participants were administered a single oral dose of CTB 1200 mg along with a single oral dose of AVP 1350 mg in any of the treatment periods.
OG004
CTB 1600 mg (Part-1)
Healthy participants were administered a single oral dose of CTB 1600 mg in any of the treatment periods.
Units
Counts
Participants
OG0006
OG0016
OG0026
OG003
Title
Denominators
Categories
Title
Measurements
OG000236.9± 18
OG001194.6± 13
OG002216.7± 14
OG003
Primary
Terminal Half-Life (t1/2) of CTB: Part 1
T1/2 was calculated as loge(2)/kel, where kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.
Pharmacokinetic parameter set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest were reported for the given part of the study.
Posted
Mean
Standard Deviation
Hours
pre-dose,0.5,1,1.5,2,2.5,3,4,6,8,12,14 and 24 hours post dose
ID
Title
Description
OG000
CTB 400 mg + AVP 900 mg (Part-1)
Healthy participants were administered a single oral dose of CTB 400 mg along with a single oral dose of AVP 900 mg in any of the treatment periods.
OG001
CTB 800 mg + AVP 1350 mg (Part-1)
Healthy participants were administered a single oral dose of CTB 800 mg along with a single oral dose of AVP 1350 mg in any of the treatment periods.
OG002
CTB 800 mg (Part-1)
Healthy participants were administered a single oral dose of CTB 800 mg in any of the treatment periods.
OG003
CTB 1200 mg + AVP 1350 mg (Part-1)
Healthy participants were administered a single oral dose of CTB 1200 mg along with a single oral dose of AVP 1350 mg in any of the treatment periods.
OG004
CTB 1600 mg (Part-1)
Healthy participants were administered a single oral dose of CTB 1600 mg in any of the treatment periods.
Units
Counts
Participants
OG0006
OG0016
OG0026
OG003
Title
Denominators
Categories
Title
Measurements
OG0003.073± 0.54265
OG0012.708± 0.57031
OG0022.908± 0.53905
OG003
Primary
Apparent Volume of Distribution (Vz/F) of CTB: Part 1
Vz/F was calculated as Dose/(AUCinf * kel) where kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.
Pharmacokinetic parameter set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest were reported for the given part of the study.
Posted
Geometric Mean
Geometric Coefficient of Variation
Liter
pre-dose,0.5,1,1.5,2,2.5,3,4,6,8,12,14 and 24 hours post dose
ID
Title
Description
OG000
CTB 400 mg + AVP 900 mg (Part-1)
Healthy participants were administered a single oral dose of CTB 400 mg along with a single oral dose of AVP 900 mg in any of the treatment periods.
OG001
CTB 800 mg + AVP 1350 mg (Part-1)
Healthy participants were administered a single oral dose of CTB 800 mg along with a single oral dose of AVP 1350 mg in any of the treatment periods.
OG002
CTB 800 mg (Part-1)
Healthy participants were administered a single oral dose of CTB 800 mg in any of the treatment periods.
OG003
CTB 1200 mg + AVP 1350 mg (Part-1)
Healthy participants were administered a single oral dose of CTB 1200 mg along with a single oral dose of AVP 1350 mg in any of the treatment periods.
OG004
CTB 1600 mg (Part-1)
Healthy participants were administered a single oral dose of CTB 1600 mg in any of the treatment periods
Units
Counts
Participants
OG0006
OG0016
OG0026
OG003
Title
Denominators
Categories
Title
Measurements
OG00018.44± 20
OG00119.70± 14
OG00219.10± 16
OG003
Primary
Apparent Clearance (CL/F) of CTB: Part 1
CL/F was calculated as Dose/AUCinf.
Pharmacokinetic parameter set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest were reported for the given part of the study.
Posted
Geometric Mean
Geometric Coefficient of Variation
Liter per hour
pre-dose,0.5,1,1.5,2,2.5,3,4,6,8,12,14 and 24 hours post dose
ID
Title
Description
OG000
CTB 400 mg + AVP 900 mg (Part-1)
Healthy participants were administered a single oral dose of CTB 400 mg along with a single oral dose of AVP 900 mg in any of the treatment periods.
OG001
CTB 800 mg + AVP 1350 mg (Part-1)
Healthy participants were administered a single oral dose of CTB 800 mg along with a single oral dose of AVP 1350 mg in any of the treatment periods.
OG002
CTB 800 mg (Part-1)
Healthy participants were administered a single oral dose of CTB 800 mg in any of the treatment periods.
OG003
CTB 1200 mg + AVP 1350 mg (Part-1)
Healthy participants were administered a single oral dose of CTB 1200 mg along with a single oral dose of AVP 1350 mg in any of the treatment periods.
OG004
CTB 1600 mg (Part-1)
Healthy participants were administered a single oral dose of CTB 1600 mg in any of the treatment periods.
Units
Counts
Participants
OG0006
OG0016
OG0026
OG003
Title
Denominators
Categories
Title
Measurements
OG0004.221± 18
OG0015.136± 13
OG0024.620± 14
OG003
Primary
Maximum Observed Concentration (Cmax) of AVP, Avibactam (AVI) and Hydroxy Pivalic Acid (HPA): Part 1
The lower limit of quantification for AVP was 1.0 ng/mL.
Pharmacokinetic parameter set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest were reported for the given part of the study. Data is reported for CTB 400 mg + AVP 900 mg, CTB 800 mg + AVP 1350 mg and CTB 1200 mg + AVP 1350 mg arms only as only participants from these arms received AVP (AVI and HPA: metabolites of AVP).
Posted
Geometric Mean
Geometric Coefficient of Variation
Nanogram per milliliter
pre-dose,0.5,1,1.5,2,2.5,3,4,6,8,12,14 and 24 hours post dose
ID
Title
Description
OG000
CTB 400 mg + AVP 900 mg (Part-1)
Healthy participants were administered a single oral dose of CTB 400 mg along with a single oral dose of AVP 900 mg in any of the treatment periods.
OG001
CTB 800 mg + AVP 1350 mg (Part-1)
Healthy participants were administered a single oral dose of CTB 800 mg along with a single oral dose of AVP 1350 mg in any of the treatment periods.
OG002
CTB 1200 mg + AVP 1350 mg (Part-1)
Healthy participants were administered a single oral dose of CTB 1200 mg along with a single oral dose of AVP 1350 mg in any of the treatment periods.
Units
Counts
Participants
OG0006
OG0016
OG0026
Title
Denominators
Categories
AVP
Title
Measurements
OG000NA± NAData could not be calculated as values were below limit of quantification.
OG001NA± NAData could not be calculated as values were below limit of quantification.
OG002
Primary
Dose-Normalized AUClast (AUClast[dn]) of AVP, AVI and HPA: Part 1
AUClast(dn) was determined as AUClast/Dose. The lower limit of quantification for AVP was 1.0 ng/mL.
Pharmacokinetic parameter set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest were reported for the given part of the study. Data is reported for CTB 400 mg + AVP 900 mg, CTB 800 mg + AVP 1350 mg and CTB 1200 mg + AVP 1350 mg arms only as only participants from these arms received AVP (AVI and HPA: metabolites of AVP).
Posted
Geometric Mean
Geometric Coefficient of Variation
Nanogram*hour/milliliter/milligram
pre-dose,0.5,1,1.5,2,2.5,3,4,6,8,12,14 and 24 hours post dose
ID
Title
Description
OG000
CTB 400 mg + AVP 900 mg (Part-1)
Healthy participants were administered a single oral dose of CTB 400 mg along with a single oral dose of AVP 900 mg in any of the treatment periods.
OG001
CTB 800 mg + AVP 1350 mg (Part-1)
Healthy participants were administered a single oral dose of CTB 800 mg along with a single oral dose of AVP 1350 mg in any of the treatment periods
OG002
CTB 1200 mg + AVP 1350 mg (Part-1)
Healthy participants were administered a single oral dose of CTB 1200 mg along with a single oral dose of AVP 1350 mg in any of the treatment periods.
Units
Counts
Participants
OG0006
OG0016
OG0026
Title
Denominators
Categories
AVP
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0025
Title
Measurements
Primary
Time for Cmax (Tmax) of AVP, AVI and HPA: Part 1
The lower limit of quantification for AVP was 1.0 ng/mL.
Pharmacokinetic parameter analysis set. Data is reported for CTB 400 mg + AVP 900 mg, CTB 800 mg + AVP 1350 mg and CTB 1200 mg + AVP 1350 mg arms only as only participants from these arms received AVP (AVI and HPA: metabolites of AVP). Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
Posted
Median
Full Range
Hours
pre-dose,0.5,1,1.5,2,2.5,3,4,6,8,12,14 and 24 hours post dose
ID
Title
Description
OG000
CTB 400 mg + AVP 900 mg (Part-1)
Healthy participants were administered a single oral dose of CTB 400 mg along with a single oral dose of AVP 900 mg in any of the treatment periods.
OG001
CTB 800 mg + AVP 1350 mg (Part-1)
Healthy participants were administered a single oral dose of CTB 800 mg along with a single oral dose of AVP 1350 mg in any of the treatment periods.
OG002
CTB 1200 mg + AVP 1350 mg (Part-1)
Healthy participants were administered a single dose of CTB 1200 mg and AVP 1350 mg orally on day 1 in period 4
Units
Counts
Participants
OG0006
OG0016
OG0026
Title
Denominators
Categories
AVP
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0022
Title
Measurements
Primary
Dose-Normalized Cmax (Cmax[dn]) of AVP, AVI and HPA: Part 1
Dose-normalized Cmax was determined as Cmax/Dose. The lower limit of quantification for AVP was 1.0 ng/mL.
Pharmacokinetic parameter set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest were reported for the given part of the study. Data is reported for CTB 400 mg + AVP 900 mg, CTB 800 mg + AVP 1350 mg and CTB 1200 mg + AVP 1350 mg arms only as only participants from these arms received AVP (AVI and HPA: metabolites of AVP).
Posted
Geometric Mean
Geometric Coefficient of Variation
Nanogram per milliliter per milligram
pre-dose,0.5,1,1.5,2,2.5,3,4,6,8,12,14 and 24 hours post dose
ID
Title
Description
OG000
CTB 400 mg + AVP 900 mg (Part-1)
Healthy participants were administered a single oral dose of CTB 400 mg along with a single oral dose of AVP 900 mg in any of the treatment periods.
OG001
CTB 800 mg + AVP 1350 mg (Part-1)
Healthy participants were administered a single oral dose of CTB 800 mg along with a single oral dose of AVP 1350 mg in any of the treatment periods.
OG002
CTB 1200 mg + AVP 1350 mg (Part-1)
Healthy participants were administered a single oral dose of CTB 1200 mg along with a single oral dose of AVP 1350 mg in any of the treatment periods.
Units
Counts
Participants
OG0006
OG0016
OG0026
Title
Denominators
Categories
AVP
Title
Measurements
OG000NA± NAData could not be calculated as values were below limit of quantification.
OG001NA± NAData could not be calculated as values were below limit of quantification.
OG002
Primary
Area Under the Plasma Concentration Time Curve From Time Zero to the Time of Last Quantifiable Concentration (AUClast) of AVP, AVI and HPA: Part 1
AUClast was determined using the linear/log trapezoidal method. The lower limit of quantification for AVP was 1.0 ng/mL.
Pharmacokinetic parameter analysis set. Data is reported for CTB 400 mg + AVP 900 mg, CTB 800 mg + AVP 1350 mg and CTB 1200 mg + AVP 1350 mg arms only as only participants from these arms received AVP (AVI and HPA: metabolites of AVP). Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
Posted
Geometric Mean
Geometric Coefficient of Variation
Nanogram*hours per milliliter
pre-dose,0.5,1,1.5,2,2.5,3,4,6,8,12,14 and 24 hours post dose
ID
Title
Description
OG000
CTB 400 mg + AVP 900 mg (Part-1)
Healthy participants were administered a single oral dose of CTB 400 mg along with a single oral dose of AVP 900 mg in any of the treatment periods.
OG001
CTB 800 mg + AVP 1350 mg (Part-1)
Healthy participants were administered a single oral dose of CTB 800 mg along with a single oral dose of AVP 1350 mg in any of the treatment periods.
OG002
CTB 1200 mg + AVP 1350 mg (Part-1)
Healthy participants were administered a single oral dose of CTB 1200 mg along with a single oral dose of AVP 1350 mg in any of the treatment periods.
Units
Counts
Participants
OG0006
OG0016
OG0026
Title
Denominators
Categories
AVP
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0025
Title
Measurements
Primary
Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUCinf) of AVP, AVI and HPA: Part 1
AUCinf was calculated as AUClast + (Clast/kel), where Clast is the predicted plasma concentration at the last quantifiable time point from the log-linear regression analysis.
Pharmacokinetic parameter analysis set. Data is reported for CTB 400 mg + AVP 900 mg, CTB 800 mg + AVP 1350 mg and CTB 1200 mg + AVP 1350 mg arms only as only participants from these arms received AVP (AVI and HPA: metabolites of AVP). Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
Posted
Geometric Mean
Geometric Coefficient of Variation
Nanogram*hours per milliliter
pre-dose,0.5,1,1.5,2,2.5,3,4,6,8,12,14 and 24 hours post dose
ID
Title
Description
OG000
CTB 400 mg + AVP 900 mg (Part-1)
Healthy participants were administered a single oral dose of CTB 400 mg along with a single oral dose of AVP 900 mg in any of the treatment periods.
OG001
CTB 800 mg + AVP 1350 mg (Part-1)
Healthy participants were administered a single oral dose of CTB 800 mg along with a single oral dose of AVP 1350 mg in any of the treatment periods.
OG002
CTB 1200 mg + AVP 1350 mg (Part-1)
Healthy participants were administered a single oral dose of CTB 1200 mg along with a single oral dose of AVP 1350 mg in any of the treatment periods.
Units
Counts
Participants
OG0006
OG0016
OG0026
Title
Denominators
Categories
AVP
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
AVI
ParticipantsOG000
Primary
Dose-Normalized AUCinf (AUCinf[dn]) of AVP, AVI and HPA: Part 1
AUCinf(dn) was calculated as AUCinf/Dose.
Pharmacokinetic parameter analysis set. Data is reported for CTB 400 mg + AVP 900 mg, CTB 800 mg + AVP 1350 mg and CTB 1200 mg + AVP 1350 mg arms only as only participants from these arms received AVP (AVI and HPA: metabolites of AVP). Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
Posted
Geometric Mean
Geometric Coefficient of Variation
Nanogram*hour/milliliter/milligram
pre-dose,0.5,1,1.5,2,2.5,3,4,6,8,12,14 and 24 hours post dose
ID
Title
Description
OG000
CTB 400 mg + AVP 900 mg (Part-1)
Healthy participants were administered a single oral dose of CTB 400 mg along with a single oral dose of AVP 900 mg in any of the treatment periods.
OG001
CTB 800 mg + AVP 1350 mg (Part-1)
Healthy participants were administered a single oral dose of CTB 800 mg along with a single oral dose of AVP 1350 mg in any of the treatment periods.
OG002
CTB 1200 mg + AVP 1350 mg (Part-1)
Healthy participants were administered a single oral dose of CTB 1200 mg along with a single oral dose of AVP 1350 mg in any of the treatment periods.
Units
Counts
Participants
OG0006
OG0016
OG0026
Title
Denominators
Categories
AVP
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
AVI
ParticipantsOG000
Primary
Terminal Half-Life (t1/2) of AVP, AVI and HPA: Part 1
T1/2 was calculated as loge(2)/kel, where kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.
Pharmacokinetic parameter analysis set. Data is reported for CTB 400 mg + AVP 900 mg, CTB 800 mg + AVP 1350 mg and CTB 1200 mg + AVP 1350 mg arms only as only participants from these arms received AVP (AVI and HPA: metabolites of AVP). Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
Posted
Mean
Standard Deviation
Hours
pre-dose,0.5,1,1.5,2,2.5,3,4,6,8,12,14 and 24 hours post dose
ID
Title
Description
OG000
CTB 400 mg + AVP 900 mg (Part-1)
Healthy participants were administered a single oral dose of CTB 400 mg along with a single oral dose of AVP 900 mg in any of the treatment periods.
OG001
CTB 800 mg + AVP 1350 mg (Part-1)
Healthy participants were administered a single oral dose of CTB 800 mg along with a single oral dose of AVP 1350 mg in any of the treatment periods.
OG002
CTB 1200 mg + AVP 1350 mg (Part-1)
Healthy participants were administered a single oral dose of CTB 1200 mg along with a single oral dose of AVP 1350 mg in any of the treatment periods.
Units
Counts
Participants
OG0006
OG0016
OG0026
Title
Denominators
Categories
AVP
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
AVI
ParticipantsOG000
Primary
Apparent Volume of Distribution (Vz/F) of AVP, AVI and HPA : Part 1
Vz/F was calculated as Dose/(AUCinf * kel) where kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.
Pharmacokinetic parameter analysis set. Data is reported for CTB 400 mg + AVP 900 mg, CTB 800 mg + AVP 1350 mg and CTB 1200 mg + AVP 1350 mg arms only as only participants from these arms received AVP (AVI and HPA: metabolites of AVP). Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
Posted
Geometric Mean
Geometric Coefficient of Variation
Liter
pre-dose,0.5,1,1.5,2,2.5,3,4,6,8,12,14 and 24 hours post dose
ID
Title
Description
OG000
CTB 400 mg + AVP 900 mg (Part-1)
Healthy participants were administered a single oral dose of CTB 400 mg along with a single oral dose of AVP 900 mg in any of the treatment periods.
OG001
CTB 800 mg + AVP 1350 mg (Part-1)
Healthy participants were administered a single oral dose of CTB 800 mg along with a single oral dose of AVP 1350 mg in any of the treatment periods.
OG002
CTB 1200 mg + AVP 1350 mg (Part-1)
Healthy participants were administered a single oral dose of CTB 1200 mg along with a single oral dose of AVP 1350 mg in any of the treatment periods.
Units
Counts
Participants
OG0006
OG0016
OG0026
Title
Denominators
Categories
AVP
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
AVI
ParticipantsOG000
Primary
Apparent Clearance (CL/F) of AVP, AVI and HPA: Part 1
CL/F was calculated as Dose/AUCinf.
Pharmacokinetic parameter analysis set. Data is reported for CTB 400 mg + AVP 900 mg, CTB 800 mg + AVP 1350 mg and CTB 1200 mg + AVP 1350 mg arms only as only participants from these arms received AVP (AVI and HPA: metabolites of AVP). Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
Posted
Geometric Mean
Geometric Coefficient of Variation
Liter per hour
pre-dose,0.5,1,1.5,2,2.5,3,4,6,8,12,14 and 24 hours post dose
ID
Title
Description
OG000
CTB 400 mg + AVP 900 mg (Part-1)
Healthy participants were administered a single oral dose of CTB 400 mg along with a single oral dose of AVP 900 mg in any of the treatment periods.
OG001
CTB 800 mg + AVP 1350 mg (Part-1)
Healthy participants were administered a single oral dose of CTB 800 mg along with a single oral dose of AVP 1350 mg in any of the treatment periods.
OG002
CTB 1200 mg + AVP 1350 mg (Part-1)
Healthy participants were administered a single oral dose of CTB 1200 mg along with a single oral dose of AVP 1350 mg in any of the treatment periods.
Units
Counts
Participants
OG0006
OG0016
OG0026
Title
Denominators
Categories
AVP
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
AVI
ParticipantsOG000
Primary
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Severe TEAEs and Related TEAEs: Part 1
An adverse event (AE) was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. TEAEs were are any untoward medical incidence in a participant during administered study intervention, whether or not these events are related to study intervention. Severe TEAEs were defined as type of AE that interrupted usual activities of daily life (ADL), or significantly affects clinical status, or may require intensive therapeutic intervention. Related TEAEs are defined as all TEAEs considered by the investigator to have at least a 'possible' relationship with the study intervention.
Safety analysis set included all participants randomly assigned to study intervention and received at least 1 dose of study intervention. Participants were analyzed according to the treatment they actually received.
Posted
Count of Participants
Participants
From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days)
ID
Title
Description
OG000
CTB 400 mg + AVP 900 mg (Part-1)
Healthy participants were administered a single oral dose of CTB 400 mg along with a single oral dose of AVP 900 mg in any of the treatment periods.
OG001
Placebo for CTB 400 mg + AVP 900 mg (Part-1)
Healthy participants were administered a single oral dose of placebo for CTB 400 mg along with a single oral dose of AVP 900 mg in any of the treatment periods.
OG002
CTB 800 mg + AVP 1350 mg (Part-1)
Healthy participants were administered a single oral dose of CTB 800 mg along with a single oral dose of AVP 1350 mg in any of the treatment periods.
OG003
Placebo for CTB 800 mg + AVP 1350 mg
Healthy participants were administered a single oral dose of placebo for CTB 800 mg along with a single oral dose of AVP 1350 mg in any of the treatment periods.
OG004
CTB 800 mg (Part-1)
Healthy participants were administered a single oral dose of CTB 800 mg in any of the treatment periods.
OG005
Placebo for CTB 800 mg (Part-1)
Healthy participants were administered a single oral dose of placebo for CTB 800 mg in any of the treatment periods.
OG006
CTB 1200 mg + AVP 1350 mg (Part-1)
Healthy participants were administered a single oral dose of CTB 1200 mg along with a single oral dose of AVP 1350 mg in any of the treatment periods.
OG007
Placebo for CTB 1200 mg + AVP 1350 mg (Part-1)
Healthy participants were administered a single oral dose of placebo for CTB 1200 mg along with a single oral dose of AVP 1350 mg in any of the treatment periods.
OG008
CTB 1600 mg (Part-1)
Healthy participants were administered a single oral dose of CTB 1600 mg in any of the treatment periods.
OG009
Placebo for CTB 1600 mg (Part-1)
Healthy participants were administered a single oral dose of placebo for CTB 1600 mg in any of the treatment periods.
Units
Counts
Participants
OG0006
OG0012
OG0026
OG003
Title
Denominators
Categories
TEAEs
Title
Measurements
OG0002
OG0010
OG0023
OG003
Primary
Number of Participants With Withdrawals Due to TEAEs: Part 1
An AE was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. TEAEs were are any untoward medical incidence in a participant during administered study intervention, whether or not these events are related to study intervention.
Safety analysis set included all participants randomly assigned to study intervention and received at least 1 dose of study intervention. Participants were analyzed according to the treatment they actually received.
Posted
Count of Participants
Participants
From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days)
ID
Title
Description
OG000
CTB 400 mg + AVP 900 mg (Part-1)
Healthy participants were administered a single oral dose of CTB 400 mg along with a single oral dose of AVP 900 mg in any of the treatment periods.
OG001
Placebo for CTB 400 mg + AVP 900 mg (Part-1)
Healthy participants were administered a single oral dose of placebo for CTB 400 mg along with a single oral dose of AVP 900 mg in any of the treatment periods.
OG002
CTB 800 mg + AVP 1350 mg (Part-1)
Healthy participants were administered a single oral dose of CTB 800 mg along with a single oral dose of AVP 1350 mg in any of the treatment periods.
OG003
Placebo for CTB 800 mg + AVP 1350 mg
Healthy participants were administered a single oral dose of placebo for CTB 800 mg along with a single oral dose of AVP 1350 mg in any of the treatment periods.
OG004
CTB 800 mg (Part-1)
Healthy participants were administered a single oral dose of CTB 800 mg in any of the treatment periods.
OG005
Placebo for CTB 800 mg (Part-1)
Healthy participants were administered a single oral dose of placebo for CTB 800 mg in any of the treatment periods.
OG006
CTB 1200 mg + AVP 1350 mg (Part-1)
Healthy participants were administered a single oral dose of CTB 1200 mg along with a single oral dose of AVP 1350 mg in any of the treatment periods.
OG007
Placebo for CTB 1200 mg + AVP 1350 mg (Part-1)
Healthy participants were administered a single oral dose of placebo for CTB 1200 mg along with a single oral dose of AVP 1350 mg in any of the treatment periods.
OG008
CTB 1600 mg (Part-1)
Healthy participants were administered a single oral dose of CTB 1600 mg in any of the treatment periods.
OG009
Placebo for CTB 1600 mg (Part-1)
Healthy participants were administered a single oral dose of placebo for CTB 1600 mg in any of the treatment periods.
Units
Counts
Participants
OG0006
OG0012
OG0026
OG003
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG003
Primary
Number of Participants With Laboratory Test Abnormalities: Part 1
The laboratory abnormalities with non-zero participants were reported and it included: monocytes or leukocytes (greater than [>] 1.2* upper limit of normal [ULN]), urine hemoglobin scalar (greater than or equal to [>=1]) and leukocyte esterase scalar (>=1).
Safety analysis set included all participants randomly assigned to study intervention and received at least 1 dose of study intervention. Participants were analyzed according to the treatment they actually received.
Posted
Count of Participants
Participants
Up to 24 hours post-dose
ID
Title
Description
OG000
CTB 400 mg + AVP 900 mg (Part-1)
Healthy participants were administered a single oral dose of CTB 400 mg along with a single oral dose of AVP 900 mg in any of the treatment periods.
OG001
Placebo for CTB 400 mg + AVP 900 mg (Part-1)
Healthy participants were administered a single oral dose of placebo for CTB 400 mg along with a single oral dose of AVP 900 mg in any of the treatment periods.
OG002
CTB 800 mg + AVP 1350 mg (Part-1)
Healthy participants were administered a single oral dose of CTB 800 mg along with a single oral dose of AVP 1350 mg in any of the treatment periods.
OG003
Placebo for CTB 800 mg + AVP 1350 mg
Healthy participants were administered a single oral dose of placebo for CTB 800 mg along with a single oral dose of AVP 1350 mg in any of the treatment periods.
OG004
CTB 800 mg (Part-1)
Healthy participants were administered a single oral dose of CTB 800 mg in any of the treatment periods.
OG005
Placebo for CTB 800 mg (Part-1)
Healthy participants were administered a single oral dose of placebo for CTB 800 mg in any of the treatment periods.
OG006
CTB 1200 mg + AVP 1350 mg (Part-1)
Healthy participants were administered a single oral dose of CTB 1200 mg along with a single oral dose of AVP 1350 mg in any of the treatment periods.
OG007
Placebo for CTB 1200 mg + AVP 1350 mg (Part-1)
Healthy participants were administered a single oral dose of placebo for CTB 1200 mg along with a single oral dose of AVP 1350 mg in any of the treatment periods.
OG008
CTB 1600 mg (Part-1)
Healthy participants were administered a single oral dose of CTB 1600 mg in any of the treatment periods.
OG009
Placebo for CTB 1600 mg (Part-1)
Healthy participants were administered a single oral dose of placebo for CTB 1600 mg in any of the treatment periods.
Units
Counts
Participants
OG0006
OG0012
OG0026
OG003
Title
Denominators
Categories
Monocytes/Leukocytes
Title
Measurements
OG0001
OG0010
OG0020
OG003
Primary
Number of Participants With Clinically Significant Changes in Vital Signs Abnormalities: Part 1
Vital signs included blood pressure and pulse rate and were measured in a supine position after approximately 5 minutes of rest for the participant. Clinically significant changes in vital signs were determined by the investigator.
Safety analysis set included all participants randomly assigned to study intervention and received at least 1 dose of study intervention. Participants were analyzed according to the treatment they actually received.
Posted
Count of Participants
Participants
Up to 24 hours post-dose
ID
Title
Description
OG000
CTB 400 mg + AVP 900 mg (Part-1)
Healthy participants were administered a single oral dose of CTB 400 mg along with a single oral dose of AVP 900 mg in any of the treatment periods.
OG001
Placebo for CTB 400 mg + AVP 900 mg (Part-1)
Healthy participants were administered a single oral dose of placebo for CTB 400 mg along with a single oral dose of AVP 900 mg in any of the treatment periods.
OG002
CTB 800 mg + AVP 1350 mg (Part-1)
Healthy participants were administered a single oral dose of CTB 800 mg along with a single oral dose of AVP 1350 mg in any of the treatment periods.
OG003
Placebo for CTB 800 mg + AVP 1350 mg
Healthy participants were administered a single oral dose of placebo for CTB 800 mg along with a single oral dose of AVP 1350 mg in any of the treatment periods.
OG004
CTB 800 mg (Part-1)
Healthy participants were administered a single oral dose of CTB 800 mg in any of the treatment periods.
OG005
Placebo for CTB 800 mg (Part-1)
Healthy participants were administered a single oral dose of placebo for CTB 800 mg in any of the treatment periods.
OG006
CTB 1200 mg + AVP 1350 mg (Part-1)
Healthy participants were administered a single oral dose of CTB 1200 mg along with a single oral dose of AVP 1350 mg in any of the treatment periods.
OG007
Placebo for CTB 1200 mg + AVP 1350 mg (Part-1)
Healthy participants were administered a single oral dose of placebo for CTB 1200 mg along with a single oral dose of AVP 1350 mg in any of the treatment periods.
OG008
CTB 1600 mg (Part-1)
Healthy participants were administered a single oral dose of CTB 1600 mg in any of the treatment periods.
OG009
Placebo for CTB 1600 mg (Part-1)
Healthy participants were administered a single oral dose of placebo for CTB 1600 mg in any of the treatment periods.
Units
Counts
Participants
OG0006
OG0012
OG0026
OG003
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG003
Primary
Number of Participants With Electrocardiogram (ECG) Abnormalities: Part 1
Twelve lead ECGs were collected using an ECG machine that automatically calculated heart rate and measured PR interval, QRS duration, QT interval, QT interval correct by Bazzette's formula (QTcB) and QT interval correct by Frederica formula QTcF. ECG abnormalities included: PR interval aggregate (millisecond [msec], maximum [max.] >=300; baseline > 200 and max. increase >= 25 percent (%); baseline > 200 and max. increase >= 25%), QRS duration aggregate (msec, max >=140; max. increase >= 50%), QT interval aggregate (msec, value > 500), QTCB interval aggregate and QTCF interval aggregate (msec, 450 < max <= 480; 480 < max. <= 500; max. > 500; 30 < max. increase <= 60; max. increase > 60).
Safety analysis set included all participants randomly assigned to study intervention and received at least 1 dose of study intervention. Participants were analyzed according to the treatment they actually received.
Posted
Count of Participants
Participants
Up to 24 hours post-dose
ID
Title
Description
OG000
CTB 400 mg + AVP 900 mg (Part-1)
Healthy participants were administered a single oral dose of CTB 400 mg along with a single oral dose of AVP 900 mg in any of the treatment periods.
OG001
Placebo for CTB 400 mg + AVP 900 mg (Part-1)
Healthy participants were administered a single oral dose of placebo for CTB 400 mg along with a single oral dose of AVP 900 mg in any of the treatment periods.
OG002
CTB 800 mg + AVP 1350 mg (Part-1)
Healthy participants were administered a single oral dose of CTB 800 mg along with a single oral dose of AVP 1350 mg in any of the treatment periods.
OG003
Placebo for CTB 800 mg + AVP 1350 mg
Healthy participants were administered a single oral dose of placebo for CTB 800 mg along with a single oral dose of AVP 1350 mg in any of the treatment periods.
OG004
CTB 800 mg (Part-1)
Healthy participants were administered a single oral dose of CTB 800 mg in any of the treatment periods.
OG005
Placebo for CTB 800 mg (Part-1)
Healthy participants were administered a single oral dose of placebo for CTB 800 mg in any of the treatment periods.
OG006
CTB 1200 mg + AVP 1350 mg (Part-1)
Healthy participants were administered a single oral dose of CTB 1200 mg along with a single oral dose of AVP 1350 mg in any of the treatment periods.
OG007
Placebo for CTB 1200 mg + AVP 1350 mg (Part-1)
Healthy participants were administered a single oral dose of placebo for CTB 1200 mg along with a single oral dose of AVP 1350 mg in any of the treatment periods.
OG008
CTB 1600 mg (Part-1)
Healthy participants were administered a single oral dose of CTB 1600 mg in any of the treatment periods.
OG009
Placebo for CTB 1600 mg (Part-1)
Healthy participants were administered a single oral dose of placebo for CTB 1600 mg in any of the treatment periods.
Units
Counts
Participants
OG0006
OG0012
OG0026
OG003
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG003
Primary
Maximum Observed Concentration (Cmax) of Cis-CTB and Trans-CTB: Part 2
Pharmacokinetic parameter set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest were reported for the given part of the study. Trans-CTB was measured only for CTB400 mg+AVP 1350 mg q8h arm as pre-specified in the protocol. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
Posted
Geometric Mean
Geometric Coefficient of Variation
Nanogram per milliliter
pre-dose,0.5,1,1.5,2,2.5,3,4,6 and 8 hours post dose on Day 1 and 6; pre-dose,0.5,1,1.5,2,2.5,3,4,6,8,12,16 and 24 hours post dose on Day 7
ID
Title
Description
OG000
CTB 400 mg + AVP 1350 mg q8h (Part-2)
Healthy participants were administered CTB 400 mg along with AVP 1350 mg once every 8 hours (q8h) in a fed state on Days 1 to 6 and in a fasted state on Day 7.
OG001
CTB 800 mg + AVP 1350 mg q8h (Part-2)
Healthy participants were administered CTB 800 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
OG002
CTB 400 mg + AVP 900 mg q8h (Part-2)
Healthy participants were administered CTB 400 mg along with AVP 900 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
Units
Counts
Participants
OG0006
OG0016
OG0026
Title
Denominators
Categories
Cis-CTB Day 1
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0026
Title
Measurements
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
Cis-CTB Day 6 versus Day 7
Ratio of adjusted geometric mean
104.47
2-Sided
90
84.94
128.50
Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect (fed vs fasted)
Other
OG001
Primary
Time for Cmax (Tmax) of Cis-CTB and Trans-CTB: Part 2
Pharmacokinetic parameter set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest were reported for the given part of the study. Trans-CTB was measured only for CTB400 mg+AVP 1350 mg q8h arm as pre-specified in the protocol. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
Posted
Median
Full Range
Hours
pre-dose,0.5,1,1.5,2,2.5,3,4,6 and 8 hours post dose on Day 1 and 6; pre-dose,0.5,1,1.5,2,2.5,3,4,6,8,12,16 and 24 hours post dose on Day 7
ID
Title
Description
OG000
CTB 400 mg + AVP 1350 mg q8h (Part-2)
Healthy participants were administered CTB 400 mg along with AVP 1350 mg once every 8 hours (q8h) in a fed state on Days 1 to 6 and in a fasted state on Day 7.
OG001
CTB 800 mg + AVP 1350 mg q8h (Part-2)
Healthy participants were administered CTB 800 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
OG002
CTB 400 mg + AVP 900 mg q8h (Part-2)
Healthy participants were administered CTB 400 mg along with AVP 900 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
Units
Counts
Participants
OG0006
OG0016
OG0026
Title
Denominators
Categories
Cis-CTB Day 1
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0026
Title
Measurements
Primary
Area Under the Plasma Concentration Time Curve From Time Zero to Time Tau, the Dosing Interval (AUCtau) of Cis-CTB and Trans-CTB: Part 2
Area under the plasma concentration time profile from time zero to time tau, the dosing interval, where tau is equal to 8 hours for three times daily (TID) dosing.
Pharmacokinetic parameter set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest were reported for the given part of the study. Trans-CTB was measured only for CTB400 mg+AVP 1350 mg q8h arm as pre-specified in the protocol. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
Posted
Geometric Mean
Geometric Coefficient of Variation
Nanogram*hours per milliliter
pre-dose,0.5,1,1.5,2,2.5,3,4,6 and 8 hours post dose on Day 1 and 6; pre-dose,0.5,1,1.5,2,2.5,3,4,6 and 8 hours post dose on Day 7
ID
Title
Description
OG000
CTB 400 mg + AVP 1350 mg q8h (Part-2)
Healthy participants were administered CTB 400 mg along with AVP 1350 mg once every 8 hours (q8h) in a fed state on Days 1 to 6 and in a fasted state on Day 7.
OG001
CTB 800 mg + AVP 1350 mg q8h (Part-2)
Healthy participants were administered CTB 800 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
OG002
CTB 400 mg + AVP 900 mg q8h (Part-2)
Healthy participants were administered CTB 400 mg along with AVP 900 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
Units
Counts
Participants
OG0006
OG0016
OG0026
Title
Denominators
Categories
Cis-CTB Day 1
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0026
Title
Measurements
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
Cis-CTB Day 6 versus Day 7
Ratio of adjusted geometric mean
102.21
2-Sided
90
88.67
117.80
Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect (fed vs fasted)
Other
OG001
Primary
Dose-Normalized Cmax (Cmax[dn]) of Cis-CTB and Trans-CTB : Part 2
Dose-normalized Cmax was determined as Cmax/Dose.
Pharmacokinetic parameter set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest were reported for the given part of the study. Trans-CTB was measured only for CTB400 mg+AVP 1350 mg q8h arm as pre-specified in the protocol. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
Posted
Geometric Mean
Geometric Coefficient of Variation
Nanogram per milliliter per milligram
pre-dose,0.5,1,1.5,2,2.5,3,4,6 and 8 hours post dose on Day 1 and 6; pre-dose,0.5,1,1.5,2,2.5,3,4,6,8,12,16 and 24 hours post dose on Day 7
ID
Title
Description
OG000
CTB 400 mg + AVP 1350 mg q8h (Part-2)
Healthy participants were administered CTB 400 mg along with AVP 1350 mg once every 8 hours (q8h) in a fed state on Days 1 to 6 and in a fasted state on Day 7.
OG001
CTB 800 mg + AVP 1350 mg q8h (Part-2)
Healthy participants were administered CTB 800 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
OG002
CTB 400 mg + AVP 900 mg q8h (Part-2)
Healthy participants were administered CTB 400 mg along with AVP 900 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
Units
Counts
Participants
OG0006
OG0016
OG0026
Title
Denominators
Categories
Cis-CTB Day 1
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0026
Title
Measurements
Primary
Dose-Normalized AUCtau (AUCtau[dn]) of Cis-CTB and Trans-CTB: Part 2
Area under the plasma concentration time profile from time zero to time tau, the dosing interval, where tau is equal to 8 hours for three times daily (TID) dosing.
Pharmacokinetic parameter set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest were reported for the given part of the study. Trans-CTB was measured only for CTB400 mg+AVP 1350 mg q8h arm as pre-specified in the protocol. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
Posted
Geometric Mean
Geometric Coefficient of Variation
Nanogram*hour/milliliter/milligram
pre-dose,0.5,1,1.5,2,2.5,3,4,6 and 8 hours post dose on Day 1 and 6; pre-dose,0.5,1,1.5,2,2.5,3,4,6,8,12,16 and 24 hours post dose on Day 7
ID
Title
Description
OG000
CTB 400 mg + AVP 1350 mg q8h (Part-2)
Healthy participants were administered CTB 400 mg along with AVP 1350 mg once every 8 hours (q8h) in a fed state on Days 1 to 6 and in a fasted state on Day 7.
OG001
CTB 800 mg + AVP 1350 mg q8h (Part-2)
Healthy participants were administered CTB 800 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
OG002
CTB 400 mg + AVP 900 mg q8h (Part-2)
Healthy participants were administered CTB 400 mg along with AVP 900 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
Units
Counts
Participants
OG0006
OG0016
OG0026
Title
Denominators
Categories
Cis-CTB Day 1
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0026
Title
Measurements
Primary
Terminal Half-Life (t1/2) of Cis-CTB and Trans-CTB on Day 7: Part 2
T1/2 was calculated as loge(2)/kel, where kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.
Pharmacokinetic parameter analysis set. Trans-CTB was measured only for CTB400 mg+AVP 1350 mg q8h arm as pre-specified in the protocol. Trans-CTB was measured only for CTB400 mg+AVP 1350 mg q8h arm as pre-specified in the protocol. All participants reported under 'Number of Participants Analyzed' contributed data to the table; however, may not have evaluable data for every row. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
Posted
Mean
Standard Deviation
hours
pre-dose,0.5,1,1.5,2,2.5,3,4,6,8,12,16 and 24 hours post dose on Day 7
ID
Title
Description
OG000
CTB 400 mg + AVP 1350 mg q8h (Part-2)
Healthy participants were administered CTB 400 mg along with AVP 1350 mg once every 8 hours (q8h) in a fed state on Days 1 to 6 and in a fasted state on Day 7.
OG001
CTB 800 mg + AVP 1350 mg q8h (Part-2)
Healthy participants were administered CTB 800 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
OG002
CTB 400 mg + AVP 900 mg q8h (Part-2)
Healthy participants were administered CTB 400 mg along with AVP 900 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
Units
Counts
Participants
OG0006
OG0016
OG0026
Title
Denominators
Categories
Cis-CTB Day 7
ParticipantsOG0004
ParticipantsOG0016
ParticipantsOG0026
Title
Measurements
Primary
Apparent Volume of Distribution (Vz/F) of Cis-CTB and Trans-CTB : Part 2
Vz/F was calculated as Dose/(AUCinf * kel) where kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.
Pharmacokinetic parameter analysis set. Trans-CTB was measured only for CTB400 mg+AVP 1350 mg q8h arm as pre-specified in the protocol. All participants reported under 'Number of Participants Analyzed' contributed data to the table; however, may not have evaluable data for every row. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
Posted
Geometric Mean
Geometric Coefficient of Variation
Liter
pre-dose,0.5,1,1.5,2,2.5,3,4,6 and 8 hours post dose on Day 1 and 6; pre-dose,0.5,1,1.5,2,2.5,3,4,6,8,12,16 and 24 hours post dose on Day 7
ID
Title
Description
OG000
CTB 400 mg + AVP 1350 mg q8h (Part-2)
Healthy participants were administered CTB 400 mg along with AVP 1350 mg once every 8 hours (q8h) in a fed state on Days 1 to 6 and in a fasted state on Day 7.
OG001
CTB 800 mg + AVP 1350 mg q8h (Part-2)
Healthy participants were administered CTB 800 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
OG002
CTB 400 mg + AVP 900 mg q8h (Part-2)
Healthy participants were administered CTB 400 mg along with AVP 900 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
Units
Counts
Participants
OG0006
OG0016
OG0026
Title
Denominators
Categories
Cis-CTB Day 1
ParticipantsOG0002
ParticipantsOG0011
ParticipantsOG0024
Title
Measurements
Primary
Apparent Clearance (CL/F) of Cis-CTB and Trans-CTB: Part 2
CL/F was calculated as Dose/AUCinf.
Pharmacokinetic parameter analysis set. Trans-CTB was measured only for CTB400 mg+AVP 1350 mg q8h arm as pre-specified in the protocol. All participants reported under 'Number of Participants Analyzed' contributed data to the table; however, may not have evaluable data for every row. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
Posted
Geometric Mean
Geometric Coefficient of Variation
Liter per hour
pre-dose,0.5,1,1.5,2,2.5,3,4,6 and 8 hours post dose on Day 1 and 6; pre-dose,0.5,1,1.5,2,2.5,3,4,6,8,12,16 and 24 hours post dose on Day 7
ID
Title
Description
OG000
CTB 400 mg + AVP 1350 mg q8h (Part-2)
Healthy participants were administered CTB 400 mg along with AVP 1350 mg once every 8 hours (q8h) in a fed state on Days 1 to 6 and in a fasted state on Day 7.
OG001
CTB 800 mg + AVP 1350 mg q8h (Part-2)
Healthy participants were administered CTB 800 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
OG002
CTB 400 mg + AVP 900 mg q8h (Part-2)
Healthy participants were administered CTB 400 mg along with AVP 900 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
Units
Counts
Participants
OG0006
OG0016
OG0026
Title
Denominators
Categories
Cis-CTB Day 1
ParticipantsOG0002
ParticipantsOG0011
ParticipantsOG0024
Title
Measurements
Primary
Maximum Observed Concentration (Cmax) of AVP, AVI and HPA: Part 2
The lower limit of quantification for AVP was 1.0 ng/mL.
Pharmacokinetic parameter set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest were reported for the given part of the study. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
Posted
Geometric Mean
Geometric Coefficient of Variation
Nanogram per milliliter
pre-dose,0.5,1,1.5,2,2.5,3,4,6 and 8 hours post dose on Day 1 and 6; pre-dose,0.5,1,1.5,2,2.5,3,4,6,8,12,16 and 24 hours post dose on Day 7
ID
Title
Description
OG000
CTB 400 mg + AVP 1350 mg q8h (Part-2)
Healthy participants were administered CTB 400 mg along with AVP 1350 mg once every 8 hours (q8h) in a fed state on Days 1 to 6 and in a fasted state on Day 7.
OG001
CTB 800 mg + AVP 1350 mg q8h (Part-2)
Healthy participants were administered CTB 800 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
OG002
CTB 400 mg + AVP 900 mg q8h (Part-2)
Healthy participants were administered CTB 400 mg along with AVP 900 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
Units
Counts
Participants
OG0006
OG0016
OG0026
Title
Denominators
Categories
AVP Day 1
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0026
Title
Measurements
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
AVI- Day 6 versus Day 7
Ratio of adjusted geometric mean
93.69
2-Sided
90
78.37
112.02
Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect (fed vs fasted)
Other
OG001
Primary
Area Under the Plasma Concentration Time Curve From Time Zero to Time Tau, the Dosing Interval (AUCtau) of AVP, AVI and HPA: Part 2
Area under the plasma concentration time profile from time zero to time tau, the dosing interval, where tau is equal to 8 hours for three times daily (TID) dosing.
Pharmacokinetic parameter set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest were reported for the given part of the study. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
Posted
Geometric Mean
Geometric Coefficient of Variation
Nanogram*hours per milliliter
pre-dose,0.5,1,1.5,2,2.5,3,4,6 and 8 hours post dose on Day 1 and 6; pre-dose,0.5,1,1.5,2,2.5,3,4,6 and 8 hours post dose on Day 7
ID
Title
Description
OG000
CTB 400 mg + AVP 1350 mg q8h (Part-2)
Healthy participants were administered CTB 400 mg along with AVP 1350 mg once every 8 hours (q8h) in a fed state on Days 1 to 6 and in a fasted state on Day 7.
OG001
CTB 800 mg + AVP 1350 mg q8h (Part-2)
Healthy participants were administered CTB 800 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
OG002
CTB 400 mg + AVP 900 mg q8h (Part-2)
Healthy participants were administered CTB 400 mg along with AVP 900 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
Units
Counts
Participants
OG0006
OG0016
OG0026
Title
Denominators
Categories
AVP Day 1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
AVP Day 6
ParticipantsOG000
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
AVI- Day 6 versus Day 7
Ratio of adjusted geometric mean
102.33
2-Sided
90
90.37
115.87
Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect (fed vs fasted)
Other
OG001
Primary
Time for Cmax (Tmax) of AVP, AVI and HPA: Part 2
The lower limit of quantification for AVP was 1.0 ng/mL.
Pharmacokinetic parameter set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest were reported for the given part of the study. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
Posted
Median
Full Range
Hours
pre-dose,0.5,1,1.5,2,2.5,3,4,6 and 8 hours post dose on Day 1 and 6; pre-dose,0.5,1,1.5,2,2.5,3,4,6,8,12,16 and 24 hours post dose on Day 7
ID
Title
Description
OG000
CTB 400 mg + AVP 1350 mg q8h (Part-2)
Healthy participants were administered CTB 400 mg along with AVP 1350 mg once every 8 hours (q8h) in a fed state on Days 1 to 6 and in a fasted state on Day 7.
OG001
CTB 800 mg + AVP 1350 mg q8h (Part-2)
Healthy participants were administered CTB 800 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
OG002
CTB 400 mg + AVP 900 mg q8h (Part-2)
Healthy participants were administered CTB 400 mg along with AVP 900 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
Units
Counts
Participants
OG0006
OG0016
OG0026
Title
Denominators
Categories
AVP Day 1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
AVP Day 6
ParticipantsOG000
Primary
Dose-Normalized Cmax (Cmax[dn]) of AVP, AVI and HPA: Part 2
Dose-normalized Cmax was determined as Cmax/Dose. The lower limit of quantification for AVP was 1.0 ng/mL.
Pharmacokinetic parameter set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest were reported for the given part of the study. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
Posted
Geometric Mean
Geometric Coefficient of Variation
Nanogram per milliliter per milligram
pre-dose,0.5,1,1.5,2,2.5,3,4,6 and 8 hours post dose on Day 1 and 6; pre-dose,0.5,1,1.5,2,2.5,3,4,6,8,12,16 and 24 hours post dose on Day 7
ID
Title
Description
OG000
CTB 400 mg + AVP 1350 mg q8h (Part-2)
Healthy participants were administered CTB 400 mg along with AVP 1350 mg once every 8 hours (q8h) in a fed state on Days 1 to 6 and in a fasted state on Day 7.
OG001
CTB 800 mg + AVP 1350 mg q8h (Part-2)
Healthy participants were administered CTB 800 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
OG002
CTB 400 mg + AVP 900 mg q8h (Part-2)
Healthy participants were administered CTB 400 mg along with AVP 900 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
Units
Counts
Participants
OG0006
OG0016
OG0026
Title
Denominators
Categories
AVP Day 1
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0026
Title
Measurements
Primary
Dose-Normalized AUCtau (AUCtau[dn]) of AVP, AVI and HPA: Part 2
Area under the plasma concentration time profile from time zero to time tau, the dosing interval, where tau is equal to 8 hours for three times daily (TID) dosing.
Pharmacokinetic parameter set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest were reported for the given part of the study. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
Posted
Geometric Mean
Geometric Coefficient of Variation
Nanogram*hour/milliliter/milligram
pre-dose,0.5,1,1.5,2,2.5,3,4,6 and 8 hours post dose on Day 1 and 6; pre-dose,0.5,1,1.5,2,2.5,3,4,6,8,12,16 and 24 hours post dose on Day 7
ID
Title
Description
OG000
CTB 400 mg + AVP 1350 mg q8h (Part-2)
Healthy participants were administered CTB 400 mg along with AVP 1350 mg once every 8 hours (q8h) in a fed state on Days 1 to 6 and in a fasted state on Day 7.
OG001
CTB 800 mg + AVP 1350 mg q8h (Part-2)
Healthy participants were administered CTB 800 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
OG002
CTB 400 mg + AVP 900 mg q8h (Part-2)
Healthy participants were administered CTB 400 mg along with AVP 900 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
Units
Counts
Participants
OG0006
OG0016
OG0026
Title
Denominators
Categories
AVP Day 1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
AVP Day 6
ParticipantsOG000
Primary
Terminal Half-Life (t1/2) of AVP, AVI and HPA on Day 7: Part 2
T1/2 was calculated as loge(2)/kel, where kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. The lower limit of quantification for HPA was 10.0 ng/mL.
Pharmacokinetic parameter set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest were reported for the given part of the study. All participants reported under 'Number of Participants Analyzed' contributed data to the table; however, may not have evaluable data for every row. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
Posted
Mean
Standard Deviation
hours
pre-dose,0.5,1,1.5,2,2.5,3,4,6,8,12,16 and 24 hours post dose on day 7
ID
Title
Description
OG000
CTB 400 mg + AVP 1350 mg q8h (Part-2)
Healthy participants were administered CTB 400 mg along with AVP 1350 mg once every 8 hours (q8h) in a fed state on Days 1 to 6 and in a fasted state on Day 7.
OG001
CTB 800 mg + AVP 1350 mg q8h (Part-2)
Healthy participants were administered CTB 800 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
OG002
CTB 400 mg + AVP 900 mg q8h (Part-2)
Healthy participants were administered CTB 400 mg along with AVP 900 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
Units
Counts
Participants
OG0006
OG0016
OG0026
Title
Denominators
Categories
AVP Day 7
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
AVI Day 7
ParticipantsOG000
Primary
Apparent Volume of Distribution (Vz/F) of AVP, AVI and HPA: Part 2
Vz/F was calculated as Dose/(AUCinf * kel) where kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. The lower limit of quantification for AVI and HPA was 10.0 ng/mL.
Pharmacokinetic parameter set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest were reported for the given part of the study. All participants reported under 'Number of Participants Analyzed' contributed data to the table; however, may not have evaluable data for every row. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
Posted
Geometric Mean
Geometric Coefficient of Variation
Liter
pre-dose,0.5,1,1.5,2,2.5,3,4,6 and 8 hours post dose on Day 1 and 6; pre-dose,0.5,1,1.5,2,2.5,3,4,6,8,12,16 and 24 hours post dose on Day 7
ID
Title
Description
OG000
CTB 400 mg + AVP 1350 mg q8h (Part-2)
Healthy participants were administered CTB 400 mg along with AVP 1350 mg once every 8 hours (q8h) in a fed state on Days 1 to 6 and in a fasted state on Day 7.
OG001
CTB 800 mg + AVP 1350 mg q8h (Part-2)
Healthy participants were administered CTB 800 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
OG002
CTB 400 mg + AVP 900 mg q8h (Part-2)
Healthy participants were administered CTB 400 mg along with AVP 900 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
Units
Counts
Participants
OG0006
OG0016
OG0026
Title
Denominators
Categories
AVP Day 1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
AVP Day 6
ParticipantsOG000
Primary
Apparent Clearance (CL/F) of AVP, AVI and HPA: Part 2
CL/F was calculated as Dose/AUCinf.
Pharmacokinetic parameter set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest were reported for the given part of the study. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
Posted
Geometric Mean
Geometric Coefficient of Variation
Liter per hour
pre-dose,0.5,1,1.5,2,2.5,3,4,6 and 8 hours post dose on Day 1 and 6; pre-dose,0.5,1,1.5,2,2.5,3,4,6,8,12,16 and 24 hours post dose on Day 7
ID
Title
Description
OG000
CTB 400 mg + AVP 1350 mg q8h (Part-2)
Healthy participants were administered CTB 400 mg along with AVP 1350 mg once every 8 hours (q8h) in a fed state on Days 1 to 6 and in a fasted state on Day 7.
OG001
CTB 800 mg + AVP 1350 mg q8h (Part-2)
Healthy participants were administered CTB 800 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
OG002
CTB 400 mg + AVP 900 mg q8h (Part-2)
Healthy participants were administered CTB 400 mg along with AVP 900 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
Units
Counts
Participants
OG0006
OG0016
OG0026
Title
Denominators
Categories
AVP Day 1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
AVP Day 6
ParticipantsOG000
Primary
Number of Participants With TEAEs, Severe TEAEs and Related TEAEs: Part 2
An AE was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. TEAEs were are any untoward medical incidence in a participant during administered study intervention, whether or not these events are related to study intervention. Severe TEAEs were defined as type of AE that interrupted usual ADL, or significantly affects clinical status, or may require intensive therapeutic intervention. Related TEAEs are defined as all TEAEs considered by the investigator to have at least a 'possible' relationship with the study intervention.
Safety analysis set included all participants randomly assigned to study intervention and received at least 1 dose of study intervention. Participants were analyzed according to the treatment they actually received.
Posted
Count of Participants
Participants
From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 42 days)
ID
Title
Description
OG000
CTB 400 mg + AVP 1350 mg q8h (Part-2)
Healthy participants were administered CTB 400 mg along with AVP 1350 mg once every 8 hours (q8h) in a fed state on Days 1 to 6 and in a fasted state on Day 7.
OG001
Placebo for CTB 400 mg + AVP 1350 mg q8h (Part-2)
Healthy participants were administered placebo for CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
OG002
CTB 800 mg + AVP 1350 mg q8h (Part-2)
Healthy participants were administered CTB 800 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
OG003
Placebo for CTB 800 mg + AVP 1350 mg q8h (Part-2)
Healthy participants were administered placebo for CTB 800 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
OG004
CTB 400 mg + AVP 900 mg q8h (Part-2)
Healthy participants were administered CTB 400 mg along with AVP 900 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
OG005
Placebo for CTB 400 mg + AVP 900 mg q8h (Part-2)
Healthy participants were administered placebo for CTB 400 mg along with AVP 900 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
OG006
CTB 400 mg + AVP 1350 mg q8h (Japanese) (Part 2)
Healthy Japanese participants were administered CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
Healthy Japanese participants were administered placebo for CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
OG008
CTB 400 mg + AVP 1350 mg q8h (Chinese) (Part-2)
Healthy Chinese participants were administered CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
Healthy Chinese participants were administered placebo for CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
Units
Counts
Participants
OG0006
OG0012
OG0026
OG003
Title
Denominators
Categories
TEAEs
Title
Measurements
OG0005
OG0012
OG0024
OG003
Primary
Number of Participants With Withdrawals Due to TEAEs: Part 2
An AE was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. TEAEs were any untoward medical incidence in a participant during administered study intervention, whether or not these events are related to study intervention.
Safety analysis set included all participants randomly assigned to study intervention and received at least 1 dose of study intervention. Participants were analyzed according to the treatment they actually received.
Posted
Count of Participants
Participants
From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 42 days)
ID
Title
Description
OG000
CTB 400 mg + AVP 1350 mg q8h (Part-2)
Healthy participants were administered CTB 400 mg along with AVP 1350 mg once every 8 hours (q8h) in a fed state on Days 1 to 6 and in a fasted state on Day 7.
OG001
Placebo for CTB 400 mg + AVP 1350 mg q8h (Part-2)
Healthy participants were administered placebo for CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
OG002
CTB 800 mg + AVP 1350 mg q8h (Part-2)
Healthy participants were administered CTB 800 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
OG003
Placebo for CTB 800 mg + AVP 1350 mg q8h (Part-2)
Healthy participants were administered placebo for CTB 800 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
OG004
CTB 400 mg + AVP 900 mg q8h (Part-2)
Healthy participants were administered CTB 400 mg along with AVP 900 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
OG005
Placebo for CTB 400 mg + AVP 900 mg q8h (Part-2)
Healthy participants were administered placebo for CTB 400 mg along with AVP 900 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
OG006
CTB 400 mg + AVP 1350 mg q8h (Japanese) (Part 2)
Healthy Japanese participants were administered CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
Healthy Japanese participants were administered placebo for CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
OG008
CTB 400 mg + AVP 1350 mg q8h (Chinese) (Part-2)
Healthy Chinese participants were administered CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
Healthy Chinese participants were administered placebo for CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
Units
Counts
Participants
OG0006
OG0012
OG0026
OG003
Title
Denominators
Categories
Title
Measurements
OG0002
OG0010
OG0020
OG003
Primary
Number of Participants With Laboratory Test Abnormalities: Part 2
The laboratory abnormalities with non-zero participants were reported and it included: neutrophils/ leukocytes (less than [<] 0.8x lower limit of normal [LLN]), eosinophils/leukocytes (>1.2x ULN), monocytes/leukocytes (>1.2x ULN), bicarbonate (>1.1x ULN), urine glucose (>=1), ketones scalar (>=1), urine hemoglobin scalar (>=1), leukocyte esterase scalar (>=1).
Safety analysis set included all participants randomly assigned to study intervention and received at least 1 dose of study intervention. Participants were analyzed according to the treatment they actually received.
Posted
Count of Participants
Participants
From start of treatment up to Day 7
ID
Title
Description
OG000
CTB 400 mg + AVP 1350 mg q8h (Part-2)
Healthy participants were administered CTB 400 mg along with AVP 1350 mg once every 8 hours (q8h) in a fed state on Days 1 to 6 and in a fasted state on Day 7.
OG001
Placebo for CTB 400 mg + AVP 1350 mg q8h (Part-2)
Healthy participants were administered placebo for CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
OG002
CTB 800 mg + AVP 1350 mg q8h (Part-2)
Healthy participants were administered CTB 800 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
OG003
Placebo for CTB 800 mg + AVP 1350 mg q8h (Part-2)
Healthy participants were administered placebo for CTB 800 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
OG004
CTB 400 mg + AVP 900 mg q8h (Part-2)
Healthy participants were administered CTB 400 mg along with AVP 900 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
OG005
Placebo for CTB 400 mg + AVP 900 mg q8h (Part-2)
Healthy participants were administered placebo for CTB 400 mg along with AVP 900 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
OG006
CTB 400 mg + AVP 1350 mg q8h (Japanese) (Part-2
Healthy Japanese participants were administered CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
Healthy Japanese participants were administered placebo for CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
OG008
CTB 400 mg + AVP 1350 mg q8h (Chinese) (Part-2)
Healthy Chinese participants were administered CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
Healthy Chinese participants were administered placebo for CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
Units
Counts
Participants
OG0006
OG0012
OG0026
OG003
Title
Denominators
Categories
Neutrophils/leukocytes
Title
Measurements
OG0000
OG0010
OG0020
OG003
Primary
Number of Participants With Clinically Significant Changes in Vital Signs Abnormalities: Part 2
Vital signs included blood pressure and pulse rate and were measured in a supine position after approximately 5 minutes of rest for the participant. Clinically significant changes in vital signs were determined by the investigator.
Safety analysis set included all participants randomly assigned to study intervention and received at least 1 dose of study intervention. Participants were analyzed according to the treatment they actually received.
Posted
Count of Participants
Participants
From start of treatment up to Day 7
ID
Title
Description
OG000
CTB 400 mg + AVP 1350 mg q8h (Part-2)
Healthy participants were administered CTB 400 mg along with AVP 1350 mg once every 8 hours (q8h) in a fed state on Days 1 to 6 and in a fasted state on Day 7.
OG001
Placebo for CTB 400 mg + AVP 1350 mg q8h (Part-2)
Healthy participants were administered placebo for CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
OG002
CTB 800 mg + AVP 1350 mg q8h (Part-2)
Healthy participants were administered CTB 800 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
OG003
Placebo for CTB 800 mg + AVP 1350 mg q8h (Part-2)
Healthy participants were administered placebo for CTB 800 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
OG004
CTB 400 mg + AVP 900 mg q8h (Part-2)
Healthy participants were administered CTB 400 mg along with AVP 900 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
OG005
Placebo for CTB 400 mg + AVP 900 mg q8h (Part-2)
Healthy participants were administered placebo for CTB 400 mg along with AVP 900 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
OG006
CTB 400 mg + AVP 1350 mg q8h (Japanese) (Part 2)
Healthy Japanese participants were administered CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
Healthy Japanese participants were administered placebo for CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
OG008
CTB 400 mg + AVP 1350 mg q8h (Chinese) (Part-2)
Healthy Chinese participants were administered CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
Healthy Chinese participants were administered placebo for CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
Units
Counts
Participants
OG0006
OG0012
OG0026
OG003
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG003
Primary
Number of Participants With Electrocardiogram (ECG) Abnormalities: Part 2
Twelve lead ECGs were collected using an ECG machine that automatically calculated heart rate and measured PR interval, QRS duration, QT interval, QT interval correct by Bazzette's formula (QTcB) and QT interval correct by Frederica formula QTcF. ECG abnormalities included: PR interval aggregate (millisecond [msec], maximum [max.] >=300; baseline > 200 and max. increase >= 25 percent (%); baseline > 200 and max. increase >= 25%), QRS duration aggregate (msec, max >=140; max. increase >= 50%), QT interval aggregate (msec, value > 500), QTCB interval aggregate and QTCF interval aggregate (msec, 450 < max <= 480; 480 < max. <= 500; max. > 500; 30 < max. increase <= 60; max. increase > 60).
Safety analysis set included all participants randomly assigned to study intervention and received at least 1 dose of study intervention. Participants were analyzed according to the treatment they actually received.
Posted
Count of Participants
Participants
From start of treatment up to Day 7
ID
Title
Description
OG000
CTB 400 mg + AVP 1350 mg q8h (Part-2)
Healthy participants were administered CTB 400 mg along with AVP 1350 mg once every 8 hours (q8h) in a fed state on Days 1 to 6 and in a fasted state on Day 7.
OG001
Placebo for CTB 400 mg + AVP 1350 mg q8h (Part-2)
Healthy participants were administered placebo for CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
OG002
CTB 800 mg + AVP 1350 mg q8h (Part-2)
Healthy participants were administered CTB 800 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
OG003
Placebo for CTB 800 mg + AVP 1350 mg q8h (Part-2)
Healthy participants were administered placebo for CTB 800 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
OG004
CTB 400 mg + AVP 900 mg q8h (Part-2)
Healthy participants were administered CTB 400 mg along with AVP 900 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
OG005
Placebo for CTB 400 mg + AVP 900 mg q8h (Part-2)
Healthy participants were administered placebo for CTB 400 mg along with AVP 900 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
OG006
CTB 400 mg + AVP 1350 mg q8h (Japanese) (Part 2)
Healthy Japanese participants were administered CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
Healthy Japanese participants were administered placebo for CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
OG008
CTB 400 mg + AVP 1350 mg q8h (Chinese) (Part-2)
Healthy Chinese participants were administered CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
Healthy Chinese participants were administered placebo for CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
Units
Counts
Participants
OG0006
OG0012
OG0026
OG003
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG003
Secondary
Amount Excreted in Urine as Unchanged Drug Over the Dosing Interval Tau (Aetau) of Cis-CTB, Trans-CTB, AVP, AVI and HPA: Part 2
Pharmacokinetic analysis set. Data was planned to be analyzed for CTB 400 mg + AVP 1350 mg arm only as pre-specified in the protocol. All participants reported under 'Number of Participants Analyzed' contributed data to the table; however, may not have evaluable data for every row. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
Posted
Geometric Mean
Geometric Coefficient of Variation
Milligrams
anytime between 0 to 8 hours post dose on Day 6
ID
Title
Description
OG000
CTB 400 mg + AVP 1350 mg q8h (Part-2)
Healthy participants were administered CTB 400 mg along with AVP 1350 mg once every 8 hours (q8h) in a fed state on Days 1 to 6 and in a fasted state on Day 7.
Units
Counts
Participants
OG0006
Title
Denominators
Categories
Cis CTB Day 6
ParticipantsOG0005
Title
Measurements
OG000181.8± 98
Trans CTB Day 6
ParticipantsOG000
Secondary
Percent of Dose Excreted in Urine as Unchanged Drug Over the Dosing Interval Tau (Aetau%) of Cis-CTB, Trans-CTB, AVP, AVI and HPA: Part 2
Aetau% was calculated as 100*Aetau/Dose.
Pharmacokinetic analysis set. Data was planned to be analyzed for CTB 400 mg + AVP 1350 mg arm only as pre-specified in the protocol. All participants reported under 'Number of Participants Analyzed' contributed data to the table; however, may not have evaluable data for every row. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
Posted
Geometric Mean
Geometric Coefficient of Variation
Percentage of dose excreted
anytime between 0 to 8 hours post dose on Day 6
ID
Title
Description
OG000
CTB 400 mg + AVP 1350 mg q8h (Part-2)
Healthy participants were administered CTB 400 mg along with AVP 1350 mg once every 8 hours (q8h) in a fed state on Days 1 to 6 and in a fasted state on Day 7.
Units
Counts
Participants
OG0006
Title
Denominators
Categories
Cis CTB Day 6
ParticipantsOG0005
Title
Measurements
OG00045.40± 98
Trans CTB Day 6
ParticipantsOG000
Secondary
Renal Clearance (CLr) of Cis-CTB, Trans-CTBa, AVP, AVI and HPA: Part 2
Aetau% was calculated as 100*Aetau/Dose.
Pharmacokinetic analysis set. Data was planned to be analyzed for CTB 400 mg + AVP 1350 mg arm only as pre-specified in the protocol. All participants reported under 'Number of Participants Analyzed' contributed data to the table; however, may not have evaluable data for every row. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
Posted
Geometric Mean
Geometric Coefficient of Variation
Liter per hour
anytime between 0 to 8 hours post dose on Day 6
ID
Title
Description
OG000
CTB 400 mg + AVP 1350 mg q8h (Part-2)
Healthy participants were administered CTB 400 mg along with AVP 1350 mg once every 8 hours (q8h) in a fed state on Days 1 to 6 and in a fasted state on Day 7.
Units
Counts
Participants
OG0006
Title
Denominators
Categories
Cis CTB Day 6
ParticipantsOG0004
Title
Measurements
OG0002.501± 27
Trans CTB Day 6
ParticipantsOG000
Secondary
Maximum Observed Concentration (Cmax) of Cis-CTB, AVP, AVI and HPA in Japanese and Chinese Cohorts: Part 2
The lower limit of quantification for cis-CTB was 100.0 ng/mL, and for AVI and HPA was 10.0 ng/mL.
Pharmacokinetic parameter set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest were reported for the given part of the study. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
Posted
Geometric Mean
Geometric Coefficient of Variation
Nanogram per milliliter
pre-dose,0.5,1,1.5,2,2.5,3,4,6 and 8 hours post dose on Day 1 and 6; pre-dose,0.5,1,1.5,2,2.5,3,4,6 and 8 hours post dose on Day 7
ID
Title
Description
OG000
CTB 400 mg + AVP 1350 mg q8h (Japanese) (Part-2)
Healthy Japanese participants were administered CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
OG001
CTB 400 mg + AVP 1350 mg q8h (Chinese) (Part-2)
Healthy Chinese participants were administered CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
Units
Counts
Participants
OG0005
OG0013
Title
Denominators
Categories
Cis CTB Day 1
ParticipantsOG0005
ParticipantsOG0013
Title
Measurements
OG00013660± 35
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
AVI- Day 6 versus Day 7
Ratio of adjusted geometric mean
105.47
2-Sided
90
86.64
128.39
Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect (Japanese participants fed vs fasted and Chinese participants fed vs fasted)
Other
OG001
Secondary
Time for Cmax (Tmax) of Cis-CTB, AVP, AVI and HPA in Japanese and Chinese Cohorts: Part 2
The lower limit of quantification for cis-CTB was 100.0 ng/mL, and for AVI and HPA was 10.0 ng/mL.
Pharmacokinetic parameter set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest were reported for the given part of the study. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
Posted
Median
Full Range
Hours
pre-dose,0.5,1,1.5,2,2.5,3,4,6 and 8 hours post dose on Day 1 and 6; pre-dose,0.5,1,1.5,2,2.5,3,4,6,8,12,16 and 24 hours post dose on Day 7
ID
Title
Description
OG000
CTB 400 mg + AVP 1350 mg q8h (Japanese) (Part-2)
Healthy Japanese participants were administered CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
OG001
CTB 400 mg + AVP 1350 mg q8h (Chinese) (Part-2)
Healthy Chinese participants were administered CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
Units
Counts
Participants
OG0005
OG0013
Title
Denominators
Categories
Cis CTB Day 1
ParticipantsOG0005
ParticipantsOG0013
Title
Measurements
OG0004.03(4.03 to 6.03)
Secondary
Area Under the Plasma Concentration Time Curve From Time Zero to Time Tau, the Dosing Interval (AUCtau) of Cis-CTB, AVP, AVI and HPA in Japanese and Chinese Cohorts: Part 2
Area under the plasma concentration time profile from time zero to time tau, the dosing interval, where tau is equal to 8 hours for TID dosing. The lower limit of quantification for cis-CTB was 100.0 ng/mL, and for AVI and HPA was 10.0 ng/mL.
Pharmacokinetic parameter set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest were reported for the given part of the study. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
Posted
Geometric Mean
Geometric Coefficient of Variation
Nanogram*hours per milliliter
pre-dose,0.5,1,1.5,2,2.5,3,4,6 and 8 hours post dose on Day 1 and 6; pre-dose,0.5,1,1.5,2,2.5,3,4,6 and 8 hours post dose on Day 7
ID
Title
Description
OG000
CTB 400 mg + AVP 1350 mg q8h (Japanese) (Part-2)
Healthy Japanese participants were administered CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
OG001
CTB 400 mg + AVP 1350 mg q8h (Chinese) (Part-2)
Healthy Chinese participants were administered CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
Units
Counts
Participants
OG0005
OG0013
Title
Denominators
Categories
Cis CTB Day 1
ParticipantsOG0005
ParticipantsOG0013
Title
Measurements
OG00052630± 20
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
AVI- Day 6 versus Day 7
Ratio of adjusted geometric mean
114.83
2-Sided
90
101.10
130.43
Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect (Japanese participants fed vs fasted and Chinese participants fed vs fasted)
Other
OG001
Secondary
Dose-Normalized Cmax (Cmax[dn]) of Cis-CTB, AVP, AVI and HPA in Japanese and Chinese Cohorts: Part 2
Dose-normalized Cmax was determined as Cmax/Dose. The lower limit of quantification for cis-CTB was 100.0 ng/mL, and for AVI and HPA was 10.0 ng/mL.
Pharmacokinetic parameter set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest were reported for the given part of the study. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
Posted
Geometric Mean
Geometric Coefficient of Variation
Nanogram per milliliter per milligram
pre-dose,0.5,1,1.5,2,2.5,3,4,6 and 8 hours post dose on Day 1 and 6; pre-dose,0.5,1,1.5,2,2.5,3,4,6,8,12,16 and 24 hours post dose on Day 7
ID
Title
Description
OG000
CTB 400 mg + AVP 1350 mg q8h (Japanese) (Part-2)
Healthy Japanese participants were administered CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
OG001
CTB 400 mg + AVP 1350 mg q8h (Chinese) (Part-2)
Healthy Chinese participants were administered CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
Units
Counts
Participants
OG0005
OG0013
Title
Denominators
Categories
Cis CTB Day 1
ParticipantsOG0005
ParticipantsOG0013
Title
Measurements
OG00034.16± 35
Secondary
Dose-Normalized AUCtau (AUCtau[dn]) of Cis-CTB, AVP, AVI and HPA in Japanese and Chinese Cohorts: Part 2
Area under the plasma concentration time profile from time zero to time tau, the dosing interval, where tau is equal to 8 hours for TID dosing. The lower limit of quantification for cis-CTB was 100.0 ng/mL, and for AVI and HPA was 10.0 ng/mL.
Pharmacokinetic parameter set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest were reported for the given part of the study. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
Posted
Geometric Mean
Geometric Coefficient of Variation
Nanogram*hour/milliliter/milligram
pre-dose,0.5,1,1.5,2,2.5,3,4,6 and 8 hours post dose on Day 1 and 6; pre-dose,0.5,1,1.5,2,2.5,3,4,6 and 8 hours post dose on Day 7
ID
Title
Description
OG000
CTB 400 mg + AVP 1350 mg q8h (Japanese) (Part-2)
Healthy Japanese participants were administered CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
OG001
CTB 400 mg + AVP 1350 mg q8h (Chinese) (Part-2)
Healthy Chinese participants were administered CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
Units
Counts
Participants
OG0005
OG0013
Title
Denominators
Categories
Cis CTB Day 1
ParticipantsOG0005
ParticipantsOG0013
Title
Measurements
OG000131.5± 19
Secondary
Terminal Half-Life (t1/2) of Cis-CTB, AVP, AVI and HPA in Japanese and Chinese Cohorts: Part 2
T1/2 was calculated as loge(2)/kel, where kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. The lower limit of quantification for cis-CTB was 100.0 ng/mL, and for AVI and HPA was 10.0 ng/mL.
Pharmacokinetic analysis set. It was planned to report data for CTB 400 mg + AVP 1350 mg only. All participants reported under 'Number of Participants Analyzed' contributed data to the table; however, may not have evaluable data for every row. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
Posted
Mean
Standard Deviation
Hours
pre-dose,0.5,1,1.5,2,2.5,3,4,6 and 8 hours post dose on Day 1 and 6; pre-dose,0.5,1,1.5,2,2.5,3,4,6,8,12,16 and 24 hours post dose on Day 7
ID
Title
Description
OG000
CTB 400 mg + AVP 1350 mg q8h (Japanese) (Part-2)
Healthy Japanese participants were administered CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
OG001
CTB 400 mg + AVP 1350 mg q8h (Chinese) (Part-2)
Healthy Chinese participants were administered CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
Units
Counts
Participants
OG0005
OG0013
Title
Denominators
Categories
Cis CTB Day 1
ParticipantsOG0000
ParticipantsOG0010
Cis CTB Day 6
ParticipantsOG0000
ParticipantsOG001
Secondary
Apparent Volume of Distribution (Vz/F) of Cis-CTB, AVP, AVI and HPA in Japanese and Chinese Cohorts: Part 2
Vz/F was calculated as Dose/(AUCinf * kel) where kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. The lower limit of quantification for cis-CTB was 100.0 ng/mL, and for AVI and HPA was 10.0 ng/mL.
Pharmacokinetic parameter set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest were reported for the given part of the study. All participants reported under 'Number of Participants Analyzed' contributed data to the table; however, may not have evaluable data for every row. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
Posted
Geometric Mean
Geometric Coefficient of Variation
Liter
pre-dose,0.5,1,1.5,2,2.5,3,4,6 and 8 hours post dose on Day 1 and 6; pre-dose,0.5,1,1.5,2,2.5,3,4,6,8,12,16 and 24 hours post dose on Day 7
ID
Title
Description
OG000
CTB 400 mg + AVP 1350 mg q8h (Japanese) (Part-2)
Healthy Japanese participants were administered CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
OG001
CTB 400 mg + AVP 1350 mg q8h (Chinese) (Part-2)
Healthy Chinese participants were administered CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
Units
Counts
Participants
OG0005
OG0013
Title
Denominators
Categories
Cis CTB Day 1
ParticipantsOG0000
ParticipantsOG0011
Title
Measurements
OG001NA± NAData could not be calculated as values were below limit of quantification.
Secondary
Apparent Clearance (CL/F) of Cis-CTB, AVP, AVI and HPA in Japanese and Chinese Cohorts: Part 2
CL/F was calculated as Dose/AUCinf. The lower limit of quantification for cis-CTB was 100.0 ng/mL, and for AVI and HPA was 10.0 ng/mL.
Pharmacokinetic parameter set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest were reported for the given part of the study. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
Posted
Geometric Mean
Geometric Coefficient of Variation
Liter/hour
pre-dose,0.5,1,1.5,2,2.5,3,4,6 and 8 hours post dose on Day 1 and 6; pre-dose,0.5,1,1.5,2,2.5,3,4,6,8,12,16 and 24 hours post dose on Day 7
ID
Title
Description
OG000
CTB 400 mg + AVP 1350 mg q8h (Japanese) (Part-2)
Healthy Japanese participants were administered CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
OG001
CTB 400 mg + AVP 1350 mg q8h (Chinese) (Part-2)
Healthy Chinese participants were administered CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
Units
Counts
Participants
OG0005
OG0013
Title
Denominators
Categories
Cis CTB Day 1
ParticipantsOG0000
ParticipantsOG0011
Title
Measurements
OG001NA± NAData could not be calculated as values were below limit of quantification.
0
6
0
6
2
6
EG001
Placebo for CTB 400 mg + AVP 900 mg (Part-1)
Healthy participants were administered a single oral dose of placebo for CTB 400 mg along with a single oral dose of AVP 900 mg in any of the treatment periods.
0
2
0
2
0
2
EG002
CTB 800 mg + AVP 1350 mg (Part-1)
Healthy participants were administered a single oral dose of CTB 800 mg along with a single oral dose of AVP 1350 mg in any of the treatment periods.
0
6
0
6
3
6
EG003
Placebo for CTB 800 mg + AVP 1350 mg (Part-1)
Healthy participants were administered a single oral dose of placebo for CTB 800 mg along with a single oral dose of AVP 1350 mg in any of the treatment periods.
0
2
0
2
1
2
EG004
CTB 800 mg (Part-1)
Healthy participants were administered a single oral dose of CTB 800 mg in any of the treatment periods.
0
6
0
6
0
6
EG005
Placebo for CTB 800 mg (Part-1)
Healthy participants were administered a single oral dose of placebo for CTB 800 mg in any of the treatment periods.
0
2
0
2
0
2
EG006
CTB 1200 mg + AVP 1350 mg (Part-1)
Healthy participants were administered a single oral dose of CTB 1200 mg along with a single oral dose of AVP 1350 mg in any of the treatment periods.
0
6
0
6
3
6
EG007
Placebo for CTB 1200 mg + AVP 1350 mg (Part-1)
Healthy participants were administered a single oral dose of placebo for CTB 1200 mg along with a single oral dose of AVP 1350 mg in any of the treatment periods.
0
2
0
2
1
2
EG008
CTB 1600 mg (Part-1)
Healthy participants were administered a single oral dose of CTB 1600 mg in any of the treatment periods.
0
6
0
6
3
6
EG009
Placebo for CTB 1600 mg (Part-1)
Healthy participants were administered a single oral dose of placebo for CTB 1600 mg in any of the treatment periods.
0
2
0
2
0
2
EG010
CTB 400 mg + AVP 1350 mg q8h (Part-2)
Healthy participants were administered CTB 400 mg along with AVP 1350 mg once every 8 hours (q8h) in a fed state on Days 1 to 6 and in a fasted state on Day 7.
0
6
0
6
5
6
EG011
Placebo for CTB 400 mg + AVP 1350 mg q8h (Part-2)
Healthy participants were administered placebo for CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
0
2
0
2
2
2
EG012
CTB 800 mg + AVP 1350 mg q8h (Part-2)
Healthy participants were administered CTB 800 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
0
6
0
6
4
6
EG013
Placebo for CTB 800 mg + AVP 1350 mg q8h (Part-2)
Healthy participants were administered placebo for CTB 800 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
0
2
0
2
1
2
EG014
CTB 400 mg + AVP 900 mg q8h (Part-2)
Healthy participants were administered CTB 400 mg along with AVP 900 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
0
6
0
6
5
6
EG015
Placebo for CTB 400 mg + AVP 900 mg q8h (Part-2)
Healthy participants were administered placebo for CTB 400 mg along with AVP 900 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
0
2
0
2
2
2
EG016
CTB 400 mg + AVP 1350 mg q8h (Japanese) (Part-2)
Healthy Japanese participants were administered CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
Healthy Japanese participants were administered placebo for CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
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EG018
CTB 400 mg + AVP 1350 mg q8h (Chinese) (Part-2)
Healthy Chinese participants were administered CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
Healthy Chinese participants were administered placebo for CTB 400 mg along with AVP 1350 mg q8h in a fed state on Days 1 to 6 and in a fasted state on Day 7.
0
1
0
1
0
1
EG0000 affected6 at risk
EG0010 affected2 at risk
EG0020 affected6 at risk
EG0030 affected2 at risk
EG0040 affected6 at risk
EG0050 affected2 at risk
EG0060 affected6 at risk
EG0070 affected2 at risk
EG0080 affected6 at risk
EG0090 affected2 at risk
EG0102 affected6 at risk
EG0110 affected2 at risk
EG0120 affected6 at risk
EG0130 affected2 at risk
EG0140 affected6 at risk
EG0150 affected2 at risk
EG0160 affected5 at risk
EG0170 affected1 at risk
EG0180 affected3 at risk
EG0190 affected1 at risk
Ear pain
Ear and labyrinth disorders
MedDRA v26.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected2 at risk
EG0020 affected6 at risk
EG0030 affected2 at risk
EG0040 affected6 at risk
EG0050 affected2 at risk
EG0060 affected6 at risk
EG0070 affected2 at risk
EG0080 affected6 at risk
EG0090 affected2 at risk
EG0100 affected6 at risk
EG0110 affected2 at risk
EG0120 affected6 at risk
EG0130 affected2 at risk
EG0141 affected6 at risk
EG0150 affected2 at risk
EG0160 affected5 at risk
EG0170 affected1 at risk
EG0180 affected3 at risk
EG0190 affected1 at risk
Abdominal discomfort
Gastrointestinal disorders
MedDRA v26.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected2 at risk
EG0020 affected6 at risk
EG0030 affected2 at risk
EG0040 affected6 at risk
EG0050 affected2 at risk
EG0060 affected6 at risk
EG0070 affected2 at risk
EG0080 affected6 at risk
EG0090 affected2 at risk
EG0101 affected6 at risk
EG0110 affected2 at risk
EG0121 affected6 at risk
EG0130 affected2 at risk
EG0140 affected6 at risk
EG0151 affected2 at risk
EG0160 affected5 at risk
EG0170 affected1 at risk
EG0180 affected3 at risk
EG0190 affected1 at risk
Abdominal distension
Gastrointestinal disorders
MedDRA v26.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected2 at risk
EG0020 affected6 at risk
EG0030 affected2 at risk
EG0040 affected6 at risk
EG0050 affected2 at risk
EG0060 affected6 at risk
EG0070 affected2 at risk
EG0080 affected6 at risk
EG0090 affected2 at risk
EG0100 affected6 at risk
EG0110 affected2 at risk
EG0120 affected6 at risk
EG0130 affected2 at risk
EG0140 affected6 at risk
EG0151 affected2 at risk
EG0160 affected5 at risk
EG0170 affected1 at risk
EG0180 affected3 at risk
EG0190 affected1 at risk
Abdominal pain
Gastrointestinal disorders
MedDRA v26.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected2 at risk
EG0020 affected6 at risk
EG0030 affected2 at risk
EG0040 affected6 at risk
EG0050 affected2 at risk
EG0060 affected6 at risk
EG0070 affected2 at risk
EG0080 affected6 at risk
EG0090 affected2 at risk
EG0100 affected6 at risk
EG0110 affected2 at risk
EG0121 affected6 at risk
EG0130 affected2 at risk
EG0140 affected6 at risk
EG0150 affected2 at risk
EG0160 affected5 at risk
EG0170 affected1 at risk
EG0180 affected3 at risk
EG0190 affected1 at risk
Abdominal pain lower
Gastrointestinal disorders
MedDRA v26.0
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected2 at risk
EG0020 affected6 at risk
EG0030 affected2 at risk
EG0040 affected6 at risk
EG0050 affected2 at risk
EG0060 affected6 at risk
EG0070 affected2 at risk
EG0080 affected6 at risk
EG0090 affected2 at risk
EG0100 affected6 at risk
EG0110 affected2 at risk
EG0120 affected6 at risk
EG0130 affected2 at risk
EG0140 affected6 at risk
EG0150 affected2 at risk
EG0160 affected5 at risk
EG0170 affected1 at risk
EG0180 affected3 at risk
EG0190 affected1 at risk
Abdominal pain upper
Gastrointestinal disorders
MedDRA v26.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected2 at risk
EG0020 affected6 at risk
EG0030 affected2 at risk
EG0040 affected6 at risk
EG0050 affected2 at risk
EG0061 affected6 at risk
EG0070 affected2 at risk
EG0080 affected6 at risk
EG0090 affected2 at risk
EG0100 affected6 at risk
EG0110 affected2 at risk
EG0120 affected6 at risk
EG0130 affected2 at risk
EG0140 affected6 at risk
EG0150 affected2 at risk
EG0160 affected5 at risk
EG0170 affected1 at risk
EG0180 affected3 at risk
EG0190 affected1 at risk
Diarrhoea
Gastrointestinal disorders
MedDRA v26.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected2 at risk
EG0020 affected6 at risk
EG0030 affected2 at risk
EG0040 affected6 at risk
EG0050 affected2 at risk
EG0060 affected6 at risk
EG0070 affected2 at risk
EG0080 affected6 at risk
EG0090 affected2 at risk
EG0102 affected6 at risk
EG0110 affected2 at risk
EG0122 affected6 at risk
EG0131 affected2 at risk
EG0141 affected6 at risk
EG0151 affected2 at risk
EG0160 affected5 at risk
EG0170 affected1 at risk
EG0181 affected3 at risk
EG0190 affected1 at risk
Diarrhoea haemorrhagic
Gastrointestinal disorders
MedDRA v26.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected2 at risk
EG0020 affected6 at risk
EG0030 affected2 at risk
EG0040 affected6 at risk
EG0050 affected2 at risk
EG0060 affected6 at risk
EG0070 affected2 at risk
EG0080 affected6 at risk
EG0090 affected2 at risk
EG0100 affected6 at risk
EG0110 affected2 at risk
EG0120 affected6 at risk
EG0130 affected2 at risk
EG0141 affected6 at risk
EG0150 affected2 at risk
EG0160 affected5 at risk
EG0170 affected1 at risk
EG0180 affected3 at risk
EG0190 affected1 at risk
Dry mouth
Gastrointestinal disorders
MedDRA v26.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected2 at risk
EG0020 affected6 at risk
EG0030 affected2 at risk
EG0040 affected6 at risk
EG0050 affected2 at risk
EG0060 affected6 at risk
EG0070 affected2 at risk
EG0080 affected6 at risk
EG0090 affected2 at risk
EG0100 affected6 at risk
EG0110 affected2 at risk
EG0121 affected6 at risk
EG0130 affected2 at risk
EG0140 affected6 at risk
EG0150 affected2 at risk
EG0160 affected5 at risk
EG0170 affected1 at risk
EG0180 affected3 at risk
EG0190 affected1 at risk
Dyspepsia
Gastrointestinal disorders
MedDRA v26.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected2 at risk
EG0020 affected6 at risk
EG0030 affected2 at risk
EG0040 affected6 at risk
EG0050 affected2 at risk
EG0060 affected6 at risk
EG0070 affected2 at risk
EG0080 affected6 at risk
EG0090 affected2 at risk
EG0100 affected6 at risk
EG0110 affected2 at risk
EG0120 affected6 at risk
EG0130 affected2 at risk
EG0140 affected6 at risk
EG0150 affected2 at risk
EG0160 affected5 at risk
EG0170 affected1 at risk
EG0181 affected3 at risk
EG0190 affected1 at risk
Epigastric discomfort
Gastrointestinal disorders
MedDRA v26.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected2 at risk
EG0020 affected6 at risk
EG0030 affected2 at risk
EG0040 affected6 at risk
EG0050 affected2 at risk
EG0060 affected6 at risk
EG0070 affected2 at risk
EG0080 affected6 at risk
EG0090 affected2 at risk
EG0100 affected6 at risk
EG0110 affected2 at risk
EG0121 affected6 at risk
EG0130 affected2 at risk
EG0140 affected6 at risk
EG0150 affected2 at risk
EG0160 affected5 at risk
EG0170 affected1 at risk
EG0180 affected3 at risk
EG0190 affected1 at risk
Frequent bowel movements
Gastrointestinal disorders
MedDRA v26.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected2 at risk
EG0020 affected6 at risk
EG0030 affected2 at risk
EG0040 affected6 at risk
EG0050 affected2 at risk
EG0060 affected6 at risk
EG0070 affected2 at risk
EG0080 affected6 at risk
EG0090 affected2 at risk
EG0102 affected6 at risk
EG0110 affected2 at risk
EG0120 affected6 at risk
EG0130 affected2 at risk
EG0140 affected6 at risk
EG0150 affected2 at risk
EG0160 affected5 at risk
EG0170 affected1 at risk
EG0180 affected3 at risk
EG0190 affected1 at risk
Gastrointestinal sounds abnormal
Gastrointestinal disorders
MedDRA v26.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected2 at risk
EG0020 affected6 at risk
EG0030 affected2 at risk
EG0040 affected6 at risk
EG0050 affected2 at risk
EG0060 affected6 at risk
EG0070 affected2 at risk
EG0080 affected6 at risk
EG0090 affected2 at risk
EG0101 affected6 at risk
EG0110 affected2 at risk
EG0120 affected6 at risk
EG0130 affected2 at risk
EG0140 affected6 at risk
EG0150 affected2 at risk
EG0160 affected5 at risk
EG0170 affected1 at risk
EG0180 affected3 at risk
EG0190 affected1 at risk
Haematochezia
Gastrointestinal disorders
MedDRA v26.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected2 at risk
EG0020 affected6 at risk
EG0030 affected2 at risk
EG0040 affected6 at risk
EG0050 affected2 at risk
EG0060 affected6 at risk
EG0070 affected2 at risk
EG0080 affected6 at risk
EG0090 affected2 at risk
EG0100 affected6 at risk
EG0110 affected2 at risk
EG0120 affected6 at risk
EG0130 affected2 at risk
EG0141 affected6 at risk
EG0150 affected2 at risk
EG0160 affected5 at risk
EG0170 affected1 at risk
EG0180 affected3 at risk
EG0190 affected1 at risk
Lip dry
Gastrointestinal disorders
MedDRA v26.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected2 at risk
EG0020 affected6 at risk
EG0030 affected2 at risk
EG0040 affected6 at risk
EG0050 affected2 at risk
EG0060 affected6 at risk
EG0070 affected2 at risk
EG0080 affected6 at risk
EG0090 affected2 at risk
EG0100 affected6 at risk
EG0110 affected2 at risk
EG0120 affected6 at risk
EG0130 affected2 at risk
EG0140 affected6 at risk
EG0150 affected2 at risk
EG0160 affected5 at risk
EG0170 affected1 at risk
EG0181 affected3 at risk
EG0190 affected1 at risk
Nausea
Gastrointestinal disorders
MedDRA v26.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected2 at risk
EG0020 affected6 at risk
EG0030 affected2 at risk
EG0040 affected6 at risk
EG0050 affected2 at risk
EG0061 affected6 at risk
EG0070 affected2 at risk
EG0081 affected6 at risk
EG0090 affected2 at risk
EG0102 affected6 at risk
EG0110 affected2 at risk
EG0120 affected6 at risk
EG0130 affected2 at risk
EG0140 affected6 at risk
EG0150 affected2 at risk
EG0160 affected5 at risk
EG0170 affected1 at risk
EG0180 affected3 at risk
EG0190 affected1 at risk
Odynophagia
Gastrointestinal disorders
MedDRA v26.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected2 at risk
EG0020 affected6 at risk
EG0030 affected2 at risk
EG0040 affected6 at risk
EG0050 affected2 at risk
EG0060 affected6 at risk
EG0070 affected2 at risk
EG0080 affected6 at risk
EG0090 affected2 at risk
EG0100 affected6 at risk
EG0110 affected2 at risk
EG0120 affected6 at risk
EG0131 affected2 at risk
EG0140 affected6 at risk
EG0150 affected2 at risk
EG0160 affected5 at risk
EG0170 affected1 at risk
EG0180 affected3 at risk
EG0190 affected1 at risk
Reflux gastritis
Gastrointestinal disorders
MedDRA v26.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected2 at risk
EG0020 affected6 at risk
EG0030 affected2 at risk
EG0040 affected6 at risk
EG0050 affected2 at risk
EG0060 affected6 at risk
EG0070 affected2 at risk
EG0080 affected6 at risk
EG0090 affected2 at risk
EG0101 affected6 at risk
EG0110 affected2 at risk
EG0120 affected6 at risk
EG0130 affected2 at risk
EG0140 affected6 at risk
EG0150 affected2 at risk
EG0160 affected5 at risk
EG0170 affected1 at risk
EG0180 affected3 at risk
EG0190 affected1 at risk
Asthenia
General disorders
MedDRA v26.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected2 at risk
EG0020 affected6 at risk
EG0030 affected2 at risk
EG0040 affected6 at risk
EG0050 affected2 at risk
EG0061 affected6 at risk
EG0070 affected2 at risk
EG0080 affected6 at risk
EG0090 affected2 at risk
EG0100 affected6 at risk
EG0110 affected2 at risk
EG0120 affected6 at risk
EG0130 affected2 at risk
EG0140 affected6 at risk
EG0150 affected2 at risk
EG0160 affected5 at risk
EG0170 affected1 at risk
EG0180 affected3 at risk
EG0190 affected1 at risk
Axillary pain
General disorders
MedDRA v26.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected2 at risk
EG0020 affected6 at risk
EG0030 affected2 at risk
EG0040 affected6 at risk
EG0050 affected2 at risk
EG0060 affected6 at risk
EG0070 affected2 at risk
EG0080 affected6 at risk
EG0090 affected2 at risk
EG0100 affected6 at risk
EG0110 affected2 at risk
EG0121 affected6 at risk
EG0130 affected2 at risk
EG0140 affected6 at risk
EG0150 affected2 at risk
EG0160 affected5 at risk
EG0170 affected1 at risk
EG0180 affected3 at risk
EG0190 affected1 at risk
Fatigue
General disorders
MedDRA v26.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected2 at risk
EG0021 affected6 at risk
EG0030 affected2 at risk
EG0040 affected6 at risk
EG0050 affected2 at risk
EG0060 affected6 at risk
EG0070 affected2 at risk
EG0081 affected6 at risk
EG0090 affected2 at risk
EG0100 affected6 at risk
EG0110 affected2 at risk
EG0120 affected6 at risk
EG0131 affected2 at risk
EG0140 affected6 at risk
EG0150 affected2 at risk
EG0160 affected5 at risk
EG0170 affected1 at risk
EG0180 affected3 at risk
EG0190 affected1 at risk
Feeling hot
General disorders
MedDRA v26.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected2 at risk
EG0020 affected6 at risk
EG0030 affected2 at risk
EG0040 affected6 at risk
EG0050 affected2 at risk
EG0060 affected6 at risk
EG0070 affected2 at risk
EG0080 affected6 at risk
EG0090 affected2 at risk
EG0100 affected6 at risk
EG0110 affected2 at risk
EG0121 affected6 at risk
EG0131 affected2 at risk
EG0140 affected6 at risk
EG0150 affected2 at risk
EG0160 affected5 at risk
EG0170 affected1 at risk
EG0180 affected3 at risk
EG0190 affected1 at risk
Influenza like illness
General disorders
MedDRA v26.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected2 at risk
EG0020 affected6 at risk
EG0030 affected2 at risk
EG0040 affected6 at risk
EG0050 affected2 at risk
EG0060 affected6 at risk
EG0070 affected2 at risk
EG0080 affected6 at risk
EG0090 affected2 at risk
EG0100 affected6 at risk
EG0110 affected2 at risk
EG0120 affected6 at risk
EG0130 affected2 at risk
EG0141 affected6 at risk
EG0150 affected2 at risk
EG0160 affected5 at risk
EG0170 affected1 at risk
EG0180 affected3 at risk
EG0190 affected1 at risk
Vessel puncture site bruise
General disorders
MedDRA v26.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected2 at risk
EG0022 affected6 at risk
EG0030 affected2 at risk
EG0040 affected6 at risk
EG0050 affected2 at risk
EG0062 affected6 at risk
EG0070 affected2 at risk
EG0080 affected6 at risk
EG0090 affected2 at risk
EG0100 affected6 at risk
EG0110 affected2 at risk
EG0120 affected6 at risk
EG0130 affected2 at risk
EG0140 affected6 at risk
EG0150 affected2 at risk
EG0160 affected5 at risk
EG0170 affected1 at risk
EG0180 affected3 at risk
EG0190 affected1 at risk
Gastroenteritis
Infections and infestations
MedDRA v26.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected2 at risk
EG0020 affected6 at risk
EG0030 affected2 at risk
EG0040 affected6 at risk
EG0050 affected2 at risk
EG0060 affected6 at risk
EG0070 affected2 at risk
EG0080 affected6 at risk
EG0090 affected2 at risk
EG0100 affected6 at risk
EG0110 affected2 at risk
EG0120 affected6 at risk
EG0130 affected2 at risk
EG0140 affected6 at risk
EG0151 affected2 at risk
EG0160 affected5 at risk
EG0170 affected1 at risk
EG0180 affected3 at risk
EG0190 affected1 at risk
Nasopharyngitis
Infections and infestations
MedDRA v26.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected2 at risk
EG0020 affected6 at risk
EG0030 affected2 at risk
EG0040 affected6 at risk
EG0050 affected2 at risk
EG0060 affected6 at risk
EG0070 affected2 at risk
EG0080 affected6 at risk
EG0090 affected2 at risk
EG0100 affected6 at risk
EG0110 affected2 at risk
EG0121 affected6 at risk
EG0130 affected2 at risk
EG0140 affected6 at risk
EG0150 affected2 at risk
EG0160 affected5 at risk
EG0170 affected1 at risk
EG0180 affected3 at risk
EG0190 affected1 at risk
Tinea versicolour
Infections and infestations
MedDRA v26.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected2 at risk
EG0020 affected6 at risk
EG0030 affected2 at risk
EG0040 affected6 at risk
EG0050 affected2 at risk
EG0060 affected6 at risk
EG0071 affected2 at risk
EG0080 affected6 at risk
EG0090 affected2 at risk
EG0100 affected6 at risk
EG0110 affected2 at risk
EG0120 affected6 at risk
EG0130 affected2 at risk
EG0140 affected6 at risk
EG0150 affected2 at risk
EG0160 affected5 at risk
EG0170 affected1 at risk
EG0180 affected3 at risk
EG0190 affected1 at risk
Arthropod bite
Injury, poisoning and procedural complications
MedDRA v26.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected2 at risk
EG0020 affected6 at risk
EG0030 affected2 at risk
EG0040 affected6 at risk
EG0050 affected2 at risk
EG0060 affected6 at risk
EG0071 affected2 at risk
EG0080 affected6 at risk
EG0090 affected2 at risk
EG0100 affected6 at risk
EG0110 affected2 at risk
EG0120 affected6 at risk
EG0130 affected2 at risk
EG0140 affected6 at risk
EG0150 affected2 at risk
EG0160 affected5 at risk
EG0170 affected1 at risk
EG0180 affected3 at risk
EG0190 affected1 at risk
Contusion
Injury, poisoning and procedural complications
MedDRA v26.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected2 at risk
EG0020 affected6 at risk
EG0030 affected2 at risk
EG0040 affected6 at risk
EG0050 affected2 at risk
EG0060 affected6 at risk
EG0070 affected2 at risk
EG0080 affected6 at risk
EG0090 affected2 at risk
EG0100 affected6 at risk
EG0110 affected2 at risk
EG0120 affected6 at risk
EG0130 affected2 at risk
EG0140 affected6 at risk
EG0150 affected2 at risk
EG0160 affected5 at risk
EG0170 affected1 at risk
EG0181 affected3 at risk
EG0190 affected1 at risk
Tooth fracture
Injury, poisoning and procedural complications
MedDRA v26.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected2 at risk
EG0020 affected6 at risk
EG0030 affected2 at risk
EG0040 affected6 at risk
EG0050 affected2 at risk
EG0060 affected6 at risk
EG0070 affected2 at risk
EG0080 affected6 at risk
EG0090 affected2 at risk
EG0101 affected6 at risk
EG0110 affected2 at risk
EG0120 affected6 at risk
EG0130 affected2 at risk
EG0140 affected6 at risk
EG0150 affected2 at risk
EG0160 affected5 at risk
EG0170 affected1 at risk
EG0180 affected3 at risk
EG0190 affected1 at risk
Alanine aminotransferase increased
Investigations
MedDRA v26.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected2 at risk
EG0020 affected6 at risk
EG0030 affected2 at risk
EG0040 affected6 at risk
EG0050 affected2 at risk
EG0060 affected6 at risk
EG0070 affected2 at risk
EG0080 affected6 at risk
EG0090 affected2 at risk
EG0100 affected6 at risk
EG0110 affected2 at risk
EG0120 affected6 at risk
EG0130 affected2 at risk
EG0140 affected6 at risk
EG0151 affected2 at risk
EG0160 affected5 at risk
EG0170 affected1 at risk
EG0180 affected3 at risk
EG0190 affected1 at risk
Groin pain
Musculoskeletal and connective tissue disorders
MedDRA v26.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected2 at risk
EG0020 affected6 at risk
EG0030 affected2 at risk
EG0040 affected6 at risk
EG0050 affected2 at risk
EG0060 affected6 at risk
EG0070 affected2 at risk
EG0080 affected6 at risk
EG0090 affected2 at risk
EG0100 affected6 at risk
EG0110 affected2 at risk
EG0120 affected6 at risk
EG0130 affected2 at risk
EG0140 affected6 at risk
EG0150 affected2 at risk
EG0160 affected5 at risk
EG0170 affected1 at risk
EG0181 affected3 at risk
EG0190 affected1 at risk
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA v26.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected2 at risk
EG0020 affected6 at risk
EG0030 affected2 at risk
EG0040 affected6 at risk
EG0050 affected2 at risk
EG0060 affected6 at risk
EG0070 affected2 at risk
EG0080 affected6 at risk
EG0090 affected2 at risk
EG0100 affected6 at risk
EG0110 affected2 at risk
EG0120 affected6 at risk
EG0131 affected2 at risk
EG0140 affected6 at risk
EG0150 affected2 at risk
EG0160 affected5 at risk
EG0170 affected1 at risk
EG0181 affected3 at risk
EG0190 affected1 at risk
Dizziness
Nervous system disorders
MedDRA v26.0
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected2 at risk
EG0020 affected6 at risk
EG0030 affected2 at risk
EG0040 affected6 at risk
EG0050 affected2 at risk
EG0060 affected6 at risk
EG0070 affected2 at risk
EG0080 affected6 at risk
EG0090 affected2 at risk
EG0100 affected6 at risk
EG0110 affected2 at risk
EG0120 affected6 at risk
EG0130 affected2 at risk
EG0141 affected6 at risk
EG0150 affected2 at risk
EG0160 affected5 at risk
EG0170 affected1 at risk
EG0180 affected3 at risk
EG0190 affected1 at risk
Dizziness postural
Nervous system disorders
MedDRA v26.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected2 at risk
EG0020 affected6 at risk
EG0030 affected2 at risk
EG0040 affected6 at risk
EG0050 affected2 at risk
EG0060 affected6 at risk
EG0070 affected2 at risk
EG0080 affected6 at risk
EG0090 affected2 at risk
EG0100 affected6 at risk
EG0110 affected2 at risk
EG0120 affected6 at risk
EG0130 affected2 at risk
EG0140 affected6 at risk
EG0150 affected2 at risk
EG0161 affected5 at risk
EG0170 affected1 at risk
EG0180 affected3 at risk
EG0190 affected1 at risk
Headache
Nervous system disorders
MedDRA v26.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected2 at risk
EG0020 affected6 at risk
EG0030 affected2 at risk
EG0040 affected6 at risk
EG0050 affected2 at risk
EG0061 affected6 at risk
EG0070 affected2 at risk
EG0081 affected6 at risk
EG0090 affected2 at risk
EG0101 affected6 at risk
EG0111 affected2 at risk
EG0121 affected6 at risk
EG0130 affected2 at risk
EG0142 affected6 at risk
EG0150 affected2 at risk
EG0160 affected5 at risk
EG0170 affected1 at risk
EG0180 affected3 at risk
EG0190 affected1 at risk
Presyncope
Nervous system disorders
MedDRA v26.0
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected2 at risk
EG0020 affected6 at risk
EG0030 affected2 at risk
EG0040 affected6 at risk
EG0050 affected2 at risk
EG0060 affected6 at risk
EG0070 affected2 at risk
EG0080 affected6 at risk
EG0090 affected2 at risk
EG0100 affected6 at risk
EG0110 affected2 at risk
EG0120 affected6 at risk
EG0130 affected2 at risk
EG0140 affected6 at risk
EG0150 affected2 at risk
EG0160 affected5 at risk
EG0170 affected1 at risk
EG0180 affected3 at risk
EG0190 affected1 at risk
Somnolence
Nervous system disorders
MedDRA v26.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected2 at risk
EG0020 affected6 at risk
EG0030 affected2 at risk
EG0040 affected6 at risk
EG0050 affected2 at risk
EG0060 affected6 at risk
EG0070 affected2 at risk
EG0080 affected6 at risk
EG0090 affected2 at risk
EG0100 affected6 at risk
EG0110 affected2 at risk
EG0120 affected6 at risk
EG0130 affected2 at risk
EG0141 affected6 at risk
EG0150 affected2 at risk
EG0160 affected5 at risk
EG0170 affected1 at risk
EG0180 affected3 at risk
EG0190 affected1 at risk
Anxiety
Psychiatric disorders
MedDRA v26.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected2 at risk
EG0020 affected6 at risk
EG0030 affected2 at risk
EG0040 affected6 at risk
EG0050 affected2 at risk
EG0060 affected6 at risk
EG0070 affected2 at risk
EG0080 affected6 at risk
EG0090 affected2 at risk
EG0100 affected6 at risk
EG0110 affected2 at risk
EG0120 affected6 at risk
EG0130 affected2 at risk
EG0140 affected6 at risk
EG0150 affected2 at risk
EG0160 affected5 at risk
EG0170 affected1 at risk
EG0181 affected3 at risk
EG0190 affected1 at risk
Dysuria
Renal and urinary disorders
MedDRA v26.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected2 at risk
EG0020 affected6 at risk
EG0030 affected2 at risk
EG0040 affected6 at risk
EG0050 affected2 at risk
EG0060 affected6 at risk
EG0070 affected2 at risk
EG0080 affected6 at risk
EG0090 affected2 at risk
EG0101 affected6 at risk
EG0110 affected2 at risk
EG0120 affected6 at risk
EG0130 affected2 at risk
EG0140 affected6 at risk
EG0150 affected2 at risk
EG0160 affected5 at risk
EG0170 affected1 at risk
EG0182 affected3 at risk
EG0190 affected1 at risk
Polyuria
Renal and urinary disorders
MedDRA v26.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected2 at risk
EG0020 affected6 at risk
EG0030 affected2 at risk
EG0040 affected6 at risk
EG0050 affected2 at risk
EG0060 affected6 at risk
EG0070 affected2 at risk
EG0080 affected6 at risk
EG0090 affected2 at risk
EG0100 affected6 at risk
EG0110 affected2 at risk
EG0120 affected6 at risk
EG0130 affected2 at risk
EG0140 affected6 at risk
EG0151 affected2 at risk
EG0160 affected5 at risk
EG0170 affected1 at risk
EG0180 affected3 at risk
EG0190 affected1 at risk
Dysmenorrhoea
Reproductive system and breast disorders
MedDRA v26.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected2 at risk
EG0020 affected6 at risk
EG0030 affected2 at risk
EG0040 affected6 at risk
EG0050 affected2 at risk
EG0061 affected6 at risk
EG0070 affected2 at risk
EG0080 affected6 at risk
EG0090 affected2 at risk
EG0100 affected6 at risk
EG0110 affected2 at risk
EG0120 affected6 at risk
EG0130 affected2 at risk
EG0140 affected6 at risk
EG0150 affected2 at risk
EG0160 affected5 at risk
EG0170 affected1 at risk
EG0180 affected3 at risk
EG0190 affected1 at risk
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA v26.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected2 at risk
EG0020 affected6 at risk
EG0030 affected2 at risk
EG0040 affected6 at risk
EG0050 affected2 at risk
EG0060 affected6 at risk
EG0070 affected2 at risk
EG0080 affected6 at risk
EG0090 affected2 at risk
EG0100 affected6 at risk
EG0110 affected2 at risk
EG0120 affected6 at risk
EG0131 affected2 at risk
EG0140 affected6 at risk
EG0150 affected2 at risk
EG0161 affected5 at risk
EG0170 affected1 at risk
EG0180 affected3 at risk
EG0190 affected1 at risk
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA v26.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected2 at risk
EG0020 affected6 at risk
EG0031 affected2 at risk
EG0040 affected6 at risk
EG0050 affected2 at risk
EG0060 affected6 at risk
EG0070 affected2 at risk
EG0080 affected6 at risk
EG0090 affected2 at risk
EG0100 affected6 at risk
EG0110 affected2 at risk
EG0120 affected6 at risk
EG0130 affected2 at risk
EG0140 affected6 at risk
EG0150 affected2 at risk
EG0160 affected5 at risk
EG0170 affected1 at risk
EG0180 affected3 at risk
EG0190 affected1 at risk
Oropharyngeal discomfort
Respiratory, thoracic and mediastinal disorders
MedDRA v26.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected2 at risk
EG0020 affected6 at risk
EG0030 affected2 at risk
EG0040 affected6 at risk
EG0050 affected2 at risk
EG0060 affected6 at risk
EG0070 affected2 at risk
EG0080 affected6 at risk
EG0090 affected2 at risk
EG0100 affected6 at risk
EG0110 affected2 at risk
EG0120 affected6 at risk
EG0130 affected2 at risk
EG0140 affected6 at risk
EG0150 affected2 at risk
EG0161 affected5 at risk
EG0170 affected1 at risk
EG0180 affected3 at risk
EG0190 affected1 at risk
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA v26.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected2 at risk
EG0020 affected6 at risk
EG0030 affected2 at risk
EG0040 affected6 at risk
EG0050 affected2 at risk
EG0060 affected6 at risk
EG0070 affected2 at risk
EG0080 affected6 at risk
EG0090 affected2 at risk
EG0100 affected6 at risk
EG0110 affected2 at risk
EG0120 affected6 at risk
EG0130 affected2 at risk
EG0141 affected6 at risk
EG0150 affected2 at risk
EG0160 affected5 at risk
EG0170 affected1 at risk
EG0180 affected3 at risk
EG0190 affected1 at risk
Acne
Skin and subcutaneous tissue disorders
MedDRA v26.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected2 at risk
EG0020 affected6 at risk
EG0030 affected2 at risk
EG0040 affected6 at risk
EG0050 affected2 at risk
EG0060 affected6 at risk
EG0070 affected2 at risk
EG0080 affected6 at risk
EG0090 affected2 at risk
EG0100 affected6 at risk
EG0110 affected2 at risk
EG0121 affected6 at risk
EG0130 affected2 at risk
EG0140 affected6 at risk
EG0151 affected2 at risk
EG0160 affected5 at risk
EG0170 affected1 at risk
EG0180 affected3 at risk
EG0190 affected1 at risk
Dermatitis acneiform
Skin and subcutaneous tissue disorders
MedDRA v26.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected2 at risk
EG0020 affected6 at risk
EG0030 affected2 at risk
EG0040 affected6 at risk
EG0050 affected2 at risk
EG0060 affected6 at risk
EG0070 affected2 at risk
EG0080 affected6 at risk
EG0090 affected2 at risk
EG0101 affected6 at risk
EG0110 affected2 at risk
EG0120 affected6 at risk
EG0130 affected2 at risk
EG0140 affected6 at risk
EG0150 affected2 at risk
EG0160 affected5 at risk
EG0170 affected1 at risk
EG0180 affected3 at risk
EG0190 affected1 at risk
Dry skin
Skin and subcutaneous tissue disorders
MedDRA v26.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected2 at risk
EG0020 affected6 at risk
EG0030 affected2 at risk
EG0040 affected6 at risk
EG0050 affected2 at risk
EG0060 affected6 at risk
EG0070 affected2 at risk
EG0080 affected6 at risk
EG0090 affected2 at risk
EG0101 affected6 at risk
EG0110 affected2 at risk
EG0120 affected6 at risk
EG0130 affected2 at risk
EG0140 affected6 at risk
EG0150 affected2 at risk
EG0160 affected5 at risk
EG0170 affected1 at risk
EG0180 affected3 at risk
EG0190 affected1 at risk
Petechiae
Skin and subcutaneous tissue disorders
MedDRA v26.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected2 at risk
EG0020 affected6 at risk
EG0030 affected2 at risk
EG0040 affected6 at risk
EG0050 affected2 at risk
EG0060 affected6 at risk
EG0070 affected2 at risk
EG0080 affected6 at risk
EG0090 affected2 at risk
EG0100 affected6 at risk
EG0110 affected2 at risk
EG0120 affected6 at risk
EG0130 affected2 at risk
EG0140 affected6 at risk
EG0150 affected2 at risk
EG0160 affected5 at risk
EG0170 affected1 at risk
EG0181 affected3 at risk
EG0190 affected1 at risk
Haematoma
Vascular disorders
MedDRA v26.0
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected2 at risk
EG0020 affected6 at risk
EG0030 affected2 at risk
EG0040 affected6 at risk
EG0050 affected2 at risk
EG0060 affected6 at risk
EG0070 affected2 at risk
EG0080 affected6 at risk
EG0090 affected2 at risk
EG0100 affected6 at risk
EG0111 affected2 at risk
EG0120 affected6 at risk
EG0130 affected2 at risk
EG0141 affected6 at risk
EG0150 affected2 at risk
EG0160 affected5 at risk
EG0170 affected1 at risk
EG0181 affected3 at risk
EG0190 affected1 at risk
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Organic Chemicals
D013843
Thiazines
D013457
Sulfur Compounds
D006574
Heterocyclic Compounds, 2-Ring
D000072471
Heterocyclic Compounds, Fused-Ring
D006571
Heterocyclic Compounds
4
BG0051
BG0060
BG0070
BG0082
BG0090
BG0101
BG0110
BG0121
BG0130
BG01410
0
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
BG0111
BG0120
BG0131
BG0142
6
BG0052
BG0066
BG0072
BG0086
BG0092
BG0105
BG0110
BG0122
BG0130
BG01437
0
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
BG0111
BG0120
BG0131
BG0142
0
BG0050
BG0061
BG0070
BG0080
BG0090
BG0100
BG0110
BG0120
BG0130
BG0141
0
BG0050
BG0061
BG0070
BG0080
BG0090
BG0105
BG0110
BG0123
BG0130
BG0149
0
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
BG0111
BG0120
BG0131
BG0142
6
OG0046
5.05
(4.03 to 6.05)
OG0044.01(2.02 to 4.10)
6
OG0046
183600
± 15
OG004319200± 24
6
OG0046
22.61
± 12
OG00428.12± 25
6
OG0046
152.9
± 15
OG004199.6± 24
6
OG0046
184900
± 15
OG004321900± 24
6
OG0046
153.8
± 15
OG004200.9± 24
6
OG0046
3.138
± 0.27600
OG0043.180± 0.28817
6
OG0046
29.28
± 14
OG00422.72± 30
6
OG0046
6.492
± 15
OG0044.973± 24
NA
± NA
Data could not be calculated as values were below limit of quantification.
AVI
Title
Measurements
OG0003856± 44
OG0015955± 13
OG0026714± 26
HPA
Title
Measurements
OG0001521± 33
OG0012552± 14
OG0022676± 36
OG000
NA
± NA
Data could not be calculated as values were below limit of quantification.
OG001NA± NAData could not be calculated as values were below limit of quantification.
OG002NA± NAData could not be calculated as values were below limit of quantification.
AVI
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0026
Title
Measurements
OG00036.10± 33
OG00140.91± 13
OG00241.67± 19
HPA
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0026
Title
Measurements
OG00037.04± 24
OG00143.89± 11
OG00243.59± 23
OG000
NA
(NA to NA)
Data could not be calculated as values were below limit of quantification.
OG002NA(NA to NA)Data could not be calculated as values were below limit of quantification.
AVI
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0026
Title
Measurements
OG0004.01(2.08 to 6.00)
OG0013.50(1.50 to 6.00)
OG0024.50(2.50 to 6.02)
HPA
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0026
Title
Measurements
OG0004.01(1.50 to 6.00)
OG0014.00(1.00 to 6.00)
OG0024.50(2.50 to 6.02)
NA
± NA
Data could not be calculated as values were below limit of quantification.
AVI
Title
Measurements
OG0006.388± 44
OG0016.583± 13
OG0027.422± 26
HPA
Title
Measurements
OG0005.635± 33
OG0016.300± 14
OG0026.608± 36
OG000
NA
± NA
Data could not be calculated as values were below limit of quantification.
OG001NA± NAData could not be calculated as values were below limit of quantification.
OG002NA± NAData could not be calculated as values were below limit of quantification.
AVI
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0026
Title
Measurements
OG00021760± 33
OG00137000± 13
OG00237680± 19
HPA
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0026
Title
Measurements
OG0009996± 24
OG00117790± 12
OG00217670± 23
6
ParticipantsOG0016
ParticipantsOG0026
Title
Measurements
OG00022050± 34
OG00138060± 13
OG00238090± 19
HPA
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0026
Title
Measurements
OG00010220± 24
OG00118440± 10
OG00217950± 22
6
ParticipantsOG0016
ParticipantsOG0026
Title
Measurements
OG00036.58± 34
OG00142.10± 13
OG00242.11± 19
HPA
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0026
Title
Measurements
OG00037.86± 24
OG00145.59± 10
OG00244.35± 22
6
ParticipantsOG0016
ParticipantsOG0026
Title
Measurements
OG0004.043± 1.0748
OG0015.302± 1.4722
OG0023.632± 0.86092
HPA
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0026
Title
Measurements
OG0004.218± 0.92090
OG0015.347± 1.5405
OG0023.853± 0.86710
6
ParticipantsOG0016
ParticipantsOG0026
Title
Measurements
OG000154.6± 27
OG001175.0± 33
OG002121.5± 33
HPA
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0026
Title
Measurements
OG000157.6± 24
OG001163.2± 35
OG002122.7± 36
6
ParticipantsOG0016
ParticipantsOG0026
Title
Measurements
OG00027.35± 34
OG00123.75± 13
OG00223.75± 19
HPA
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0026
Title
Measurements
OG00026.44± 24
OG00121.92± 10
OG00222.53± 22
2
OG0046
OG0052
OG0066
OG0072
OG0086
OG0092
1
OG0040
OG0050
OG0063
OG0071
OG0083
OG0090
Severe TEAEs
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
Related TEAEs
Title
Measurements
OG0001
OG0010
OG0020
OG0030
OG0040
OG0050
OG0062
OG0070
OG0083
OG0090
2
OG0046
OG0052
OG0066
OG0072
OG0086
OG0092
0
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
2
OG0046
OG0052
OG0066
OG0072
OG0086
OG0092
1
OG0040
OG0051
OG0061
OG0070
OG0081
OG0091
Urine Hemoglobin (Scalar)
Title
Measurements
OG0000
OG0011
OG0020
OG0030
OG0041
OG0050
OG0061
OG0070
OG0083
OG0090
Leukocyte Esterase (Scalar)
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0041
OG0050
OG0060
OG0070
OG0080
OG0090
2
OG0046
OG0052
OG0066
OG0072
OG0086
OG0092
0
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
2
OG0046
OG0052
OG0066
OG0072
OG0086
OG0092
0
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG00014610± 21
OG00122730± 26
OG00217270± 11
Cis-CTB Day 6
ParticipantsOG0004
ParticipantsOG0016
ParticipantsOG0026
Title
Measurements
OG00022630± 7
OG00145640± 24
OG00220680± 16
Cis-CTB Day 7
ParticipantsOG0004
ParticipantsOG0016
ParticipantsOG0026
Title
Measurements
OG00021660± 17
OG00135240± 25
OG00220390± 10
Trans-CTB Day 1
ParticipantsOG0006
ParticipantsOG0010
ParticipantsOG0020
Title
Measurements
OG000834.7± 17
Trans-CTB Day 6
ParticipantsOG0004
ParticipantsOG0010
ParticipantsOG0020
Title
Measurements
OG0001428± 12
Trans-CTB Day 7
ParticipantsOG0004
ParticipantsOG0010
ParticipantsOG0020
Title
Measurements
OG0001641± 15
Cis-CTB Day 6 versus Day 7
Ratio of adjusted geometric mean
129.54
2-Sided
90
119.37
140.58
Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect (fed vs fasted)
Other
OG002
Cis-CTB Day 6 versus Day 7
Ratio of adjusted geometric mean
101.46
2-Sided
90
88.68
116.08
Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect (fed vs fasted)
Other
OG000
Trans-CTB Day 6 versus Day 7
Ratio of adjusted geometric means
86.99
2-Sided
90
74.48
101.59
Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect (fed vs fasted) for CTB 400 mg + AVP 1350 mg only
Other
OG0002.54(2.03 to 4.22)
OG0013.53(2.03 to 4.03)
OG0022.53(1.53 to 6.03)
Cis-CTB Day 6
ParticipantsOG0004
ParticipantsOG0016
ParticipantsOG0026
Title
Measurements
OG0002.80(2.03 to 4.03)
OG0013.53(2.53 to 4.05)
OG0023.28(1.05 to 6.03)
Cis-CTB Day 7
ParticipantsOG0004
ParticipantsOG0016
ParticipantsOG0026
Title
Measurements
OG0002.05(1.53 to 2.53)
OG0012.03(1.53 to 2.55)
OG0022.29(1.53 to 3.03)
Trans-CTB Day 1
ParticipantsOG0006
ParticipantsOG0010
ParticipantsOG0020
Title
Measurements
OG0005.13(4.03 to 6.08)
Trans-CTB Day 6
ParticipantsOG0004
ParticipantsOG0010
ParticipantsOG0020
Title
Measurements
OG0003.54(3.03 to 4.03)
Trans-CTB Day 7
ParticipantsOG0004
ParticipantsOG0010
ParticipantsOG0020
Title
Measurements
OG0003.54(3.03 to 4.03)
OG00064640± 14
OG001113100± 22
OG00267730± 11
Cis-CTB Day 6
ParticipantsOG0004
ParticipantsOG0016
ParticipantsOG0026
Title
Measurements
OG000104200± 10
OG001224300± 23
OG00293590± 17
Cis-CTB Day 7
ParticipantsOG0004
ParticipantsOG0016
ParticipantsOG0026
Title
Measurements
OG000101900± 11
OG001167600± 24
OG00293660± 8
Trans-CTB Day 1
ParticipantsOG0006
ParticipantsOG0010
ParticipantsOG0020
Title
Measurements
OG0004112± 13
Trans-CTB Day 6
ParticipantsOG0004
ParticipantsOG0010
ParticipantsOG0020
Title
Measurements
OG0008968± 11
Trans-CTB Day 7
ParticipantsOG0004
ParticipantsOG0010
ParticipantsOG0020
Title
Measurements
OG00010060± 12
Cis-CTB Day 6 versus Day 7
Ratio of adjusted geometric mean
133.79
2-Sided
90
119.84
149.36
Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect (fed vs fasted)
Other
OG002
Cis-CTB Day 6 versus Day 7
Ratio of adjusted geometric mean
99.93
2-Sided
90
90.70
110.10
Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect (fed vs fasted)
Other
OG000
Trans-CTB Day 6 versus Day 7
Ratio of adjusted geometric mean
89.17
2-Sided
90
75.27
105.63
Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect (fed vs fasted) for CTB 400 mg + AVP 1350 mg only
Other
OG00036.56± 21
OG00128.43± 26
OG00243.22± 11
Cis-CTB Day 6
ParticipantsOG0004
ParticipantsOG0016
ParticipantsOG0026
Title
Measurements
OG00056.59± 7
OG00157.06± 24
OG00251.72± 16
Cis-CTB Day 7
ParticipantsOG0004
ParticipantsOG0016
ParticipantsOG0026
Title
Measurements
OG00054.21± 17
OG00144.08± 25
OG00251.00± 10
Trans-CTB Day 1
ParticipantsOG0006
ParticipantsOG0010
ParticipantsOG0020
Title
Measurements
OG0002.089± 17
Trans-CTB Day 6
ParticipantsOG0004
ParticipantsOG0010
ParticipantsOG0020
Title
Measurements
OG0003.572± 12
Trans-CTB Day 7
ParticipantsOG0004
ParticipantsOG0010
ParticipantsOG0020
Title
Measurements
OG0004.105± 15
OG000161.6± 14
OG001141.6± 22
OG002169.5± 11
Cis-CTB Day 6
ParticipantsOG0004
ParticipantsOG0016
ParticipantsOG0026
Title
Measurements
OG000260.4± 9
OG001280.7± 23
OG002234.2± 17
Cis-CTB Day 7
ParticipantsOG0004
ParticipantsOG0016
ParticipantsOG0026
Title
Measurements
OG000255.6± 11
OG001209.8± 24
OG002234.1± 8
Trans-CTB Day 1
ParticipantsOG0006
ParticipantsOG0010
ParticipantsOG0020
Title
Measurements
OG00010.28± 13
Trans-CTB Day 6
ParticipantsOG0004
ParticipantsOG0010
ParticipantsOG0020
Title
Measurements
OG00022.45± 11
Trans-CTB Day 7
ParticipantsOG0004
ParticipantsOG0010
ParticipantsOG0020
Title
Measurements
OG00025.20± 12
OG0003.710± 0.47011
OG0013.930± 0.61106
OG0023.030± 0.32668
Trans-CTB Day 7
ParticipantsOG0004
ParticipantsOG0010
ParticipantsOG0020
Title
Measurements
OG0004.040± 0.84699
OG00016.5± 13.7
OG00115.6± NAGeometric CV could not be calculated as only 1 participant was analyzed.
OG00215.37± 15
Cis-CTB Day 6
ParticipantsOG0002
ParticipantsOG0012
ParticipantsOG0022
Title
Measurements
OG00016.5± 13.8
OG00111.5± 8.95
OG00214.8± 11.2
Cis-CTB Day 7
ParticipantsOG0004
ParticipantsOG0016
ParticipantsOG0026
Title
Measurements
OG00020.86± 22
OG00126.76± 36
OG00218.58± 13
Trans-CTB Day 1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
Trans-CTB Day 6
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
Trans-CTB Day 7
ParticipantsOG0004
ParticipantsOG0010
ParticipantsOG0020
Title
Measurements
OG000227.5± 25
OG0004.61± 4.45
OG0014.89± NAGeometric CV could not be calculated as only 1 participant was analyzed.
OG0025.014± 10
Cis-CTB Day 6
ParticipantsOG0002
ParticipantsOG0012
ParticipantsOG0022
Title
Measurements
OG0003.844± 10
OG0013.579± 23
OG0024.283± 17
Cis-CTB Day 7
ParticipantsOG0004
ParticipantsOG0016
ParticipantsOG0026
Title
Measurements
OG0003.914± 11
OG0014.774± 24
OG0024.273± 8
Trans-CTB Day 1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
Trans-CTB Day 6
ParticipantsOG0004
ParticipantsOG0010
ParticipantsOG0020
Title
Measurements
OG00044.85± 12
Trans-CTB Day 7
ParticipantsOG0004
ParticipantsOG0010
ParticipantsOG0020
Title
Measurements
OG00039.67± 12
OG000NA± NAData could not be calculated as values were below limit of quantification.
OG001NA± NAData could not be calculated as values were below limit of quantification.
OG002NA± NAData could not be calculated as values were below limit of quantification.
AVP Day 6
ParticipantsOG0004
ParticipantsOG0016
ParticipantsOG0026
Title
Measurements
OG000NA± NAData could not be calculated as values were below limit of quantification.
OG001NA± NAData could not be calculated as values were below limit of quantification.
OG002NA± NAData could not be calculated as values were below limit of quantification.
AVP Day 7
ParticipantsOG0004
ParticipantsOG0016
ParticipantsOG0026
Title
Measurements
OG000NA± NAData could not be calculated as values were below limit of quantification.
OG001NA± NAData could not be calculated as values were below limit of quantification.
OG002NA± NAData could not be calculated as values were below limit of quantification.
AVI Day 1
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0026
Title
Measurements
OG0006249± 25
OG0015852± 12
OG0024779± 27
AVI Day 6
ParticipantsOG0004
ParticipantsOG0016
ParticipantsOG0026
Title
Measurements
OG0007940± 15
OG0018676± 37
OG0026159± 15
AVI Day 7
ParticipantsOG0004
ParticipantsOG0016
ParticipantsOG0026
Title
Measurements
OG0008474± 12
OG0017673± 20
OG0025753± 12
HPA Day 1
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0026
Title
Measurements
OG0002568± 29
OG0012539± 10
OG0021977± 25
HPA Day 6
ParticipantsOG0004
ParticipantsOG0016
ParticipantsOG0026
Title
Measurements
OG0003216± 28
OG0013432± 35
OG0022643± 20
HPA Day 7
ParticipantsOG0004
ParticipantsOG0016
ParticipantsOG0026
Title
Measurements
OG0003986± 24
OG0013817± 21
OG0022707± 15
AVI-CTB Day 6 versus Day 7
Ratio of adjusted geometric mean
113.07
2-Sided
90
88.31
144.76
Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect (fed vs fasted)
Other
OG002
AVI- Day 6 versus Day 7
Ratio of adjusted geometric mean
107.06
90
92.77
123.54
Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect (fed vs fasted)
Other
OG000
HPA- Day 6 versus Day 7
Ratio of adjusted geometric mean
80.68
2-Sided
90
68.32
95.27
Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect (fed vs fasted)
Other
OG001
HPA- Day 6 versus Day 7
Ratio of adjusted geometric mean
89.92
2-Sided
90
69.70
116.02
Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect (fed vs fasted)
Other
OG002
HPA- Day 6 versus Day 7
Ratio of adjusted geometric mean
97.65
2-Sided
90
84.08
113.41
Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect (fed vs fasted)
Other
0
ParticipantsOG0010
ParticipantsOG0020
AVP Day 7
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
AVI Day 1
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0026
Title
Measurements
OG00029480± 16
OG00127920± 24
OG00222530± 15
AVI Day 6
ParticipantsOG0004
ParticipantsOG0016
ParticipantsOG0026
Title
Measurements
OG00039570± 14
OG00145130± 21
OG00229920± 17
AVI Day 7
ParticipantsOG0004
ParticipantsOG0016
ParticipantsOG0026
Title
Measurements
OG00038670± 16
OG00138300± 19
OG00225810± 9
HPA Day 1
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0026
Title
Measurements
OG00012310± 28
OG00112740± 23
OG0029623± 22
HPA Day 6
ParticipantsOG0004
ParticipantsOG0016
ParticipantsOG0026
Title
Measurements
OG00017910± 32
OG00120020± 30
OG00214190± 22
HPA Day 7
ParticipantsOG0004
ParticipantsOG0016
ParticipantsOG0026
Title
Measurements
OG00021000± 22
OG00120500± 22
OG00213790± 16
AVI- Day 6 versus Day 7
Ratio of adjusted geometric mean
117.83
2-Sided
90
100.61
138.00
Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect (fed vs fasted)
Other
OG002
AVI- Day 6 versus Day 7
Ratio of adjusted geometric mean
115.88
2-Sided
90
104.12
128.98
Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect (fed vs fasted)
Other
OG000
HPA- Day 6 versus Day 7
Ratio of adjusted geometric mean
85.27
2-Sided
90
70.37
103.32
Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect (fed vs fasted)
Other
OG001
HPA- Day 6 versus Day 7
Ratio of adjusted geometric mean
97.69
2-Sided
90
78.83
121.06
Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect (fed vs fasted)
Other
OG002
HPA- Day 6 versus Day 7
Ratio of adjusted geometric mean
102.85
2-Sided
90
94.80
111.58
Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect (fed vs fasted)
Other
0
ParticipantsOG0010
ParticipantsOG0020
AVP Day 7
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0021
Title
Measurements
OG002NA(NA to NA)Data could not be calculated as values were below limit of quantification.
AVI Day 1
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0026
Title
Measurements
OG0004.02(2.50 to 6.00)
OG0014.00(2.50 to 6.00)
OG0024.49(1.50 to 6.02)
AVI Day 6
ParticipantsOG0004
ParticipantsOG0016
ParticipantsOG0026
Title
Measurements
OG0002.77(2.00 to 4.00)
OG0012.50(0.000 to 4.00)
OG0022.75(1.02 to 6.00)
AVI Day 7
ParticipantsOG0004
ParticipantsOG0016
ParticipantsOG0026
Title
Measurements
OG0001.75(1.00 to 3.00)
OG0012.00(1.00 to 4.00)
OG0022.54(1.00 to 3.00)
HPA Day 1
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0026
Title
Measurements
OG0005.02(2.50 to 6.02)
OG0014.00(2.50 to 6.00)
OG0024.49(1.50 to 6.02)
HPA Day 6
ParticipantsOG0004
ParticipantsOG0016
ParticipantsOG0026
Title
Measurements
OG0002.52(2.00 to 4.00)
OG0012.50(0.000 to 3.00)
OG0022.02(0.500 to 6.00)
HPA Day 7
ParticipantsOG0004
ParticipantsOG0016
ParticipantsOG0026
Title
Measurements
OG0001.75(0.500 to 3.00)
OG0012.26(1.00 to 4.00)
OG0022.30(1.00 to 3.00)
OG000NA± NAData could not be calculated as values were below limit of quantification.
OG001NA± NAData could not be calculated as values were below limit of quantification.
OG002NA± NAData could not be calculated as values were below limit of quantification.
AVP Day 6
ParticipantsOG0004
ParticipantsOG0016
ParticipantsOG0026
Title
Measurements
OG000NA± NAData could not be calculated as values were below limit of quantification.
OG001NA± NAData could not be calculated as values were below limit of quantification.
OG002NA± NAData could not be calculated as values were below limit of quantification.
AVP Day 7
ParticipantsOG0004
ParticipantsOG0016
ParticipantsOG0026
Title
Measurements
OG000NA± NAData could not be calculated as values were below limit of quantification.
OG001NA± NAData could not be calculated as values were below limit of quantification.
OG002NA± NAData could not be calculated as values were below limit of quantification.
AVI Day 1
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0026
Title
Measurements
OG0006.907± 25
OG0016.470± 12
OG0027.927± 27
AVI Day 6
ParticipantsOG0004
ParticipantsOG0016
ParticipantsOG0026
Title
Measurements
OG0008.786± 15
OG0019.587± 37
OG00210.21± 15
AVI Day 7
ParticipantsOG0004
ParticipantsOG0016
ParticipantsOG0026
Title
Measurements
OG0009.373± 12
OG0018.483± 20
OG0029.544± 12
HPA Day 1
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0026
Title
Measurements
OG0006.340± 29
OG0016.270± 10
OG0027.324± 25
HPA Day 6
ParticipantsOG0004
ParticipantsOG0016
ParticipantsOG0026
Title
Measurements
OG0007.939± 28
OG0018.471± 35
OG0029.782± 20
HPA Day 7
ParticipantsOG0004
ParticipantsOG0016
ParticipantsOG0026
Title
Measurements
OG0009.824± 23
OG0019.430± 21
OG00210.02± 15
0
ParticipantsOG0010
ParticipantsOG0020
AVP Day 7
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
AVI Day 1
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0026
Title
Measurements
OG00032.63± 16
OG00130.88± 24
OG00237.37± 15
AVI Day 6
ParticipantsOG0004
ParticipantsOG0016
ParticipantsOG0026
Title
Measurements
OG00043.77± 14
OG00149.92± 21
OG00249.62± 17
AVI Day 7
ParticipantsOG0004
ParticipantsOG0016
ParticipantsOG0026
Title
Measurements
OG00042.73± 16
OG00142.32± 19
OG00242.81± 9
HPA Day 1
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0026
Title
Measurements
OG00030.43± 28
OG00131.53± 23
OG00235.63± 21
HPA Day 6
ParticipantsOG0004
ParticipantsOG0016
ParticipantsOG0026
Title
Measurements
OG00044.19± 32
OG00149.40± 30
OG00252.59± 22
HPA Day 7
ParticipantsOG0004
ParticipantsOG0016
ParticipantsOG0026
Title
Measurements
OG00051.84± 22
OG00150.56± 22
OG00251.08± 16
3
ParticipantsOG0016
ParticipantsOG0026
Title
Measurements
OG0006.473± 1.0929
OG0018.165± 1.3241
OG0027.150± 1.8379
HPA Day 7
ParticipantsOG0003
ParticipantsOG0012
ParticipantsOG0026
Title
Measurements
OG0006.270± 0.64211
OG001NA± NAData could not be calculated as values were below limit of quantification.
OG0025.965± 1.1229
0
ParticipantsOG0010
ParticipantsOG0020
AVP Day 7
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
AVI Day 1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0023
Title
Measurements
OG00263.23± 10
AVI Day 6
ParticipantsOG0002
ParticipantsOG0013
ParticipantsOG0024
Title
Measurements
OG000NA± NAData could not be calculated as values were below limit of quantification.
OG00158.04± 25
OG00264.02± 22
AVI Day 7
ParticipantsOG0003
ParticipantsOG0016
ParticipantsOG0026
Title
Measurements
OG000228.7± 22
OG001275.1± 21
OG002234.7± 18
HPA Day 1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0022
Title
Measurements
OG002NA± NAData could not be calculated as values were below limit of quantification.
HPA Day 6
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0021
Title
Measurements
OG000NA± NAData could not be calculated as values were below limit of quantification.
OG002NA± NAData could not be calculated as values were below limit of quantification.
HPA Day 7
ParticipantsOG0003
ParticipantsOG0012
ParticipantsOG0026
Title
Measurements
OG000188.1± 24
OG001NA± NAData could not be calculated as values were below limit of quantification.
OG002165.9± 9
0
ParticipantsOG0010
ParticipantsOG0020
AVP Day 7
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
AVI Day 1
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0026
Title
Measurements
OG00030.65± 16
OG00132.38± 24
OG00226.76± 15
AVI Day 6
ParticipantsOG0004
ParticipantsOG0016
ParticipantsOG0026
Title
Measurements
OG00022.86± 14
OG00120.02± 21
OG00220.13± 17
AVI Day 7
ParticipantsOG0004
ParticipantsOG0016
ParticipantsOG0026
Title
Measurements
OG00023.41± 16
OG00123.61± 19
OG00223.34± 9
HPA Day 1
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0026
Title
Measurements
OG00032.89± 28
OG00131.73± 23
OG00228.07± 21
HPA Day 6
ParticipantsOG0004
ParticipantsOG0016
ParticipantsOG0026
Title
Measurements
OG00022.64± 32
OG00120.25± 30
OG00219.02± 22
HPA Day 7
ParticipantsOG0004
ParticipantsOG0016
ParticipantsOG0026
Title
Measurements
OG00019.28± 22
OG00119.78± 22
OG00219.59± 16
2
OG0046
OG0052
OG0065
OG0071
OG0083
OG0091
1
OG0045
OG0052
OG0062
OG0070
OG0083
OG0090
Severe TEAEs
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
Related TEAEs
Title
Measurements
OG0004
OG0011
OG0024
OG0031
OG0043
OG0052
OG0061
OG0070
OG0083
OG0090
2
OG0046
OG0052
OG0065
OG0071
OG0083
OG0091
0
OG0040
OG0051
OG0060
OG0070
OG0081
OG0090
2
OG0046
OG0052
OG0065
OG0071
OG0083
OG0091
0
OG0041
OG0050
OG0060
OG0070
OG0080
OG0090
Eosinophils/leukocytes
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0041
OG0050
OG0061
OG0070
OG0080
OG0090
Monocytes/leukocytes
Title
Measurements
OG0001
OG0010
OG0022
OG0031
OG0044
OG0050
OG0060
OG0070
OG0080
OG0090
Bicarbonate
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0061
OG0070
OG0080
OG0090
Urine glucose
Title
Measurements
OG0001
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
Ketones (scalar)
Title
Measurements
OG0001
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
Urine hemoglobin (scalar)
Title
Measurements
OG0001
OG0010
OG0020
OG0030
OG0041
OG0050
OG0060
OG0071
OG0080
OG0090
Leukocyte esterase (scalar)
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0051
OG0060
OG0070
OG0080
OG0090
2
OG0046
OG0052
OG0065
OG0071
OG0083
OG0091
0
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
2
OG0046
OG0052
OG0065
OG0071
OG0083
OG0091
0
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
5
Title
Measurements
OG00048.23± 54
AVP Day 6
ParticipantsOG0000
AVI Day 6
ParticipantsOG0005
Title
Measurements
OG000295.6± 101
HPA Day 6
ParticipantsOG0005
Title
Measurements
OG00022.01± 51
5
Title
Measurements
OG00012.08± 55
AVP Day 6
ParticipantsOG0000
AVI Day 6
ParticipantsOG0005
Title
Measurements
OG00032.68± 101
HPA Day 6
ParticipantsOG0005
Title
Measurements
OG0005.434± 51
4
Title
Measurements
OG0006.657± 27
AVP Day 6
ParticipantsOG0000
AVI Day 6
ParticipantsOG0004
Title
Measurements
OG00010.61± 34
HPA Day 6
ParticipantsOG0004
Title
Measurements
OG0001.390± 22
OG00119540± 16
Cis CTB Day 6
ParticipantsOG0005
ParticipantsOG0012
Title
Measurements
OG00022080± 11
OG001NA± NAData could not be calculated as values were below limit of quantification.
Cis CTB Day 7
ParticipantsOG0005
ParticipantsOG0012
Title
Measurements
OG00021330± 14
OG001NA± NAData could not be calculated as values were below limit of quantification.
AVP Day 1
ParticipantsOG0000
ParticipantsOG0010
AVP Day 6
ParticipantsOG0000
ParticipantsOG0010
AVP Day 7
ParticipantsOG0000
ParticipantsOG0010
AVI Day 1
ParticipantsOG0005
ParticipantsOG0013
Title
Measurements
OG0005167± 49
OG0016858± 24
AVI Day 6
ParticipantsOG0005
ParticipantsOG0012
Title
Measurements
OG0007677± 24
OG001NA± NAData could not be calculated as values were below limit of quantification.
AVI Day 7
ParticipantsOG0005
ParticipantsOG0012
Title
Measurements
OG0007279± 15
OG001NA± NAData could not be calculated as values were below limit of quantification.
HPA Day 1
ParticipantsOG0005
ParticipantsOG0013
Title
Measurements
OG0002248± 45
OG0013341± 33
HPA Day 6
ParticipantsOG0005
ParticipantsOG0012
Title
Measurements
OG0003380± 14
OG001NA± NAData could not be calculated as values were below limit of quantification.
HPA Day 7
ParticipantsOG0005
ParticipantsOG0012
Title
Measurements
OG0003708± 8
OG001NA± NAData could not be calculated as values were below limit of quantification.
AVI- Day 6 versus Day 7
Ratio of adjusted geometric mean
134.24
90
51.81
347.81
Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect (Japanese participants fed vs fasted and Chinese participants fed vs fasted)
Other
OG000
HPA- Day 6 versus Day 7
Ratio of adjusted geometric mean
91.17
90
79.54
104.51
Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect (Japanese participants fed vs fasted and Chinese participants fed vs fasted)
Other
OG001
HPA- Day 6 versus Day 7
Ratio of adjusted geometric mean
115.26
2-Sided
90
71.46
185.90
Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect (Japanese participants fed vs fasted and Chinese participants fed vs fasted)
Other
OG0013.05(2.57 to 4.05)
Cis CTB Day 6
ParticipantsOG0005
ParticipantsOG0012
Title
Measurements
OG0003.03(2.53 to 4.03)
OG001NA(NA to NA)Data could not be calculated as values were below limit of quantification.
Cis CTB Day 7
ParticipantsOG0005
ParticipantsOG0012
Title
Measurements
OG0002.03(1.53 to 3.03)
OG001NA(NA to NA)Data could not be calculated as values were below limit of quantification.
AVP Day 1
ParticipantsOG0000
ParticipantsOG0010
AVP Day 6
ParticipantsOG0000
ParticipantsOG0010
AVP Day 7
ParticipantsOG0000
ParticipantsOG0010
AVI Day 1
ParticipantsOG0005
ParticipantsOG0013
Title
Measurements
OG0006.00(1.50 to 6.00)
OG0013.02(3.00 to 6.02)
AVI Day 6
ParticipantsOG0005
ParticipantsOG0012
Title
Measurements
OG0004.00(2.50 to 6.02)
OG001NA(NA to NA)Data could not be calculated as values were below limit of quantification.
AVI Day 7
ParticipantsOG0005
ParticipantsOG0012
Title
Measurements
OG0001.50(1.00 to 2.50)
OG001NA(NA to NA)Data could not be calculated as values were below limit of quantification.
HPA Day 1
ParticipantsOG0005
ParticipantsOG0013
Title
Measurements
OG0006.00(1.00 to 6.00)
OG0014.00(2.50 to 6.02)
HPA Day 6
ParticipantsOG0005
ParticipantsOG0012
Title
Measurements
OG0002.50(2.00 to 6.02)
OG001NA(NA to NA)Data could not be calculated as values were below limit of quantification.
HPA Day 7
ParticipantsOG0005
ParticipantsOG0012
Title
Measurements
OG0002.00(0.500 to 3.00)
OG001NA(NA to NA)Data could not be calculated as values were below limit of quantification.
OG00184790± 17
Cis CTB Day 6
ParticipantsOG0005
ParticipantsOG0012
Title
Measurements
OG00092920± 9
OG001NA± NAData could not be calculated as values were below limit of quantification.
Cis CTB Day 7
ParticipantsOG0005
ParticipantsOG0012
Title
Measurements
OG00090270± 9
OG001NA± NAData could not be calculated as values were below limit of quantification.
AVP Day 1
ParticipantsOG0000
ParticipantsOG0010
AVP Day 6
ParticipantsOG0000
ParticipantsOG0010
AVP Day 7
ParticipantsOG0000
ParticipantsOG0010
AVI Day 1
ParticipantsOG0005
ParticipantsOG0013
Title
Measurements
OG00022240± 33
OG00132650± 32
AVI Day 6
ParticipantsOG0005
ParticipantsOG0012
Title
Measurements
OG00038010± 11
OG001NA± NAData could not be calculated as values were below limit of quantification.
AVI Day 7
ParticipantsOG0005
ParticipantsOG0012
Title
Measurements
OG00033100± 8
OG001NA± NAData could not be calculated as values were below limit of quantification.
HPA Day 1
ParticipantsOG0005
ParticipantsOG0013
Title
Measurements
OG00010400± 35
OG00116670± 35
HPA Day 6
ParticipantsOG0005
ParticipantsOG0012
Title
Measurements
OG00019160± 7
OG001NA± NAData could not be calculated as values were below limit of quantification.
HPA Day 7
ParticipantsOG0005
ParticipantsOG0012
Title
Measurements
OG00018890± 11
OG001NA± NAData could not be calculated as values were below limit of quantification.
AVI- Day 6 versus Day 7
Ratio of adjusted geometric mean
140.44
2-Sided
90
104.17
189.34
Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect (Japanese participants fed vs fasted and Chinese participants fed vs fasted)
Other
OG000
HPA- Day 6 versus Day 7
Ratio of adjusted geometric mean
101.46
90
90.79
113.39
Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect (Japanese participants fed vs fasted and Chinese participants fed vs fasted)
Other
OG001
HPA- Day 6 versus Day 7
Ratio of adjusted geometric means
123.20
2-Sided
90
110.25
137.67
Model is a mixed effect model with treatment as a fixed effect and participant as a random effect (Japanese participants fed vs fasted and Chinese participants fed vs fasted)
Other
OG00148.90± 16
Cis CTB Day 6
ParticipantsOG0005
ParticipantsOG0012
Title
Measurements
OG00055.21± 11
OG001NA± NAData could not be calculated as values were below limit of quantification.
Cis CTB Day 7
ParticipantsOG0005
ParticipantsOG0012
Title
Measurements
OG00053.35± 14
OG001NA± NAData could not be calculated as values were below limit of quantification.
AVP Day 1
ParticipantsOG0000
ParticipantsOG0010
AVP Day 6
ParticipantsOG0000
ParticipantsOG0010
AVP Day 7
ParticipantsOG0000
ParticipantsOG0010
AVI Day 1
ParticipantsOG0005
ParticipantsOG0013
Title
Measurements
OG0005.714± 49
OG0017.582± 24
AVI Day 6
ParticipantsOG0005
ParticipantsOG0012
Title
Measurements
OG0008.483± 24
OG001NA± NAData could not be calculated as values were below limit of quantification.
AVI Day 7
ParticipantsOG0005
ParticipantsOG0012
Title
Measurements
OG0008.046± 15
OG001NA± NAData could not be calculated as values were below limit of quantification.
HPA Day 1
ParticipantsOG0005
ParticipantsOG0013
Title
Measurements
OG0005.549± 45
OG0018.249± 33
HPA Day 6
ParticipantsOG0005
ParticipantsOG0012
Title
Measurements
OG0008.339± 14
OG001NA± NAData could not be calculated as values were below limit of quantification.
HPA Day 7
ParticipantsOG0005
ParticipantsOG0012
Title
Measurements
OG0009.145± 8
OG001NA± NAData could not be calculated as values were below limit of quantification.
OG001212.0± 17
Cis CTB Day 6
ParticipantsOG0005
ParticipantsOG0012
Title
Measurements
OG000232.3± 9
OG001NA± NAData could not be calculated as values were below limit of quantification.
Cis CTB Day 7
ParticipantsOG0005
ParticipantsOG0012
Title
Measurements
OG000225.9± 9
OG001NA± NAData could not be calculated as values were below limit of quantification.
AVP Day 1
ParticipantsOG0000
ParticipantsOG0010
AVP Day 6
ParticipantsOG0000
ParticipantsOG0010
AVP Day 7
ParticipantsOG0000
ParticipantsOG0010
AVI Day 1
ParticipantsOG0005
ParticipantsOG0013
Title
Measurements
OG00024.62± 33
OG00136.10± 32
AVI Day 6
ParticipantsOG0005
ParticipantsOG0012
Title
Measurements
OG00042.01± 11
OG001NA± NAData could not be calculated as values were below limit of quantification.
AVI Day 7
ParticipantsOG0005
ParticipantsOG0012
Title
Measurements
OG00036.59± 8
OG001NA± NAData could not be calculated as values were below limit of quantification.
HPA Day 1
ParticipantsOG0005
ParticipantsOG0013
Title
Measurements
OG00025.70± 35
OG00141.23± 35
HPA Day 6
ParticipantsOG0005
ParticipantsOG0012
Title
Measurements
OG00047.29± 7
OG001NA± NAData could not be calculated as values were below limit of quantification.
HPA Day 7
ParticipantsOG0005
ParticipantsOG0012
Title
Measurements
OG00046.65± 11
OG001NA± NAData could not be calculated as values were below limit of quantification.
0
Cis CTB Day 7
ParticipantsOG0005
ParticipantsOG0012
Title
Measurements
OG0002.788± 0.80670
OG001NA± NAData could not be calculated as values were below limit of quantification.
AVP Day 1
ParticipantsOG0000
ParticipantsOG0010
AVP Day 6
ParticipantsOG0000
ParticipantsOG0010
AVP Day 7
ParticipantsOG0000
ParticipantsOG0010
AVI Day 1
ParticipantsOG0000
ParticipantsOG0010
AVI Day 6
ParticipantsOG0000
ParticipantsOG0010
AVI Day 7
ParticipantsOG0005
ParticipantsOG0011
Title
Measurements
OG0005.734± 2.6304
OG001NA± NAData could not be calculated as values were below limit of quantification.
HPA Day 1
ParticipantsOG0000
ParticipantsOG0010
HPA Day 6
ParticipantsOG0000
ParticipantsOG0010
HPA Day 7
ParticipantsOG0005
ParticipantsOG0011
Title
Measurements
OG0005.290± 1.7122
OG001NA± NAData could not be calculated as values were below limit of quantification.
Cis CTB Day 6
ParticipantsOG0004
ParticipantsOG0010
Title
Measurements
OG00012.82± 8
Cis CTB Day 7
ParticipantsOG0005
ParticipantsOG0012
Title
Measurements
OG00017.33± 31
OG001NA± NAData could not be calculated as values were below limit of quantification.
AVP Day 1
ParticipantsOG0000
ParticipantsOG0010
AVP Day 6
ParticipantsOG0000
ParticipantsOG0010
AVP Day 7
ParticipantsOG0000
ParticipantsOG0010
AVI Day 1
ParticipantsOG0000
ParticipantsOG0010
AVI Day 6
ParticipantsOG0001
ParticipantsOG0011
Title
Measurements
OG000NA± NAData could not be calculated as values were below limit of quantification.
OG001NA± NAData could not be calculated as values were below limit of quantification.
AVI Day 7
ParticipantsOG0005
ParticipantsOG0011
Title
Measurements
OG000207.9± 43
OG001NA± NAData could not be calculated as values were below limit of quantification.
HPA Day 1
ParticipantsOG0000
ParticipantsOG0010
HPA Day 6
ParticipantsOG0001
ParticipantsOG0011
Title
Measurements
OG000NA± NAData could not be calculated as values were below limit of quantification.
OG001NA± NAData could not be calculated as values were below limit of quantification.
HPA Day 7
ParticipantsOG0005
ParticipantsOG0011
Title
Measurements
OG000156.0± 44
OG001NA± NAData could not be calculated as values were below limit of quantification.
Cis CTB Day 6
ParticipantsOG0005
ParticipantsOG0012
Title
Measurements
OG0004.303± 9
OG001NA± NAData could not be calculated as values were below limit of quantification.
Cis CTB Day 7
ParticipantsOG0005
ParticipantsOG0012
Title
Measurements
OG0004.428± 9
OG001NA± NAData could not be calculated as values were below limit of quantification.
AVP Day 1
ParticipantsOG0000
ParticipantsOG0010
AVP Day 6
ParticipantsOG0000
ParticipantsOG0010
AVP Day 7
ParticipantsOG0000
ParticipantsOG0010
AVI Day 1
ParticipantsOG0005
ParticipantsOG0013
Title
Measurements
OG00040.66± 33
OG00127.69± 32
AVI Day 6
ParticipantsOG0005
ParticipantsOG0012
Title
Measurements
OG00023.80± 11
OG001NA± NAData could not be calculated as values were below limit of quantification.
AVI Day 7
ParticipantsOG0005
ParticipantsOG0012
Title
Measurements
OG00027.33± 8
OG001NA± NAData could not be calculated as values were below limit of quantification.
HPA Day 1
ParticipantsOG0005
ParticipantsOG0013
Title
Measurements
OG00038.94± 35
OG00124.26± 35
HPA Day 6
ParticipantsOG0005
ParticipantsOG0012
Title
Measurements
OG00021.12± 7
OG001NA± NAData could not be calculated as values were below limit of quantification.
HPA Day 7
ParticipantsOG0005
ParticipantsOG0012
Title
Measurements
OG00021.42± 11
OG001NA± NAData could not be calculated as values were below limit of quantification.