A TAK-831-1001, Single and Multiple Rising Dose Study in... | NCT02566759 | Trialant
NCT02566759
Sponsor
Neurocrine Biosciences
Status
Terminated
Last Update Posted
Jun 14, 2021Actual
Enrollment
110Actual
Phase
Phase 1
Conditions
Schizophrenia, Cerebellar Ataxia
Interventions
TAK-831 Oral Suspension
TAK-831 Placebo
TAK-831 Tablet
Countries
United Kingdom
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
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
NCT02566759
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
TAK-831-1001
Secondary IDs
ID
Type
Description
Link
2015-002295-24
EudraCT Number
U1111-1168-6568
Registry Identifier
WHO
15/SC/0412
Registry Identifier
NRES
Brief Title
A TAK-831-1001, Single and Multiple Rising Dose Study in Healthy Participants
Official Title
A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Safety, Tolerability and Pharmacokinetic Study of Escalating Single and Multiple Doses of TAK-831 in Healthy Subjects
Acronym
Not provided
Organization
Neurocrine BiosciencesINDUSTRY
Status Module
Record Verification Date
Jun 2021
Overall Recruitment Status or Expanded Access Status
Terminated
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
The study was terminated by Takeda due to the discomfort observed in the study participants from the CSF collection procedure in Part 3 of the study.
Expanded Access Info
No
Start Date
Sep 23, 2015
Primary Completion Date
Jun 9, 2016Actual
Completion Date
Jul 12, 2016Actual
First Submitted Date
Oct 1, 2015
First Submission Date that Met QC Criteria
Oct 1, 2015
First Posted Date
Oct 2, 2015Estimated
Results Waived
Not provided
Results First Submitted Date
Aug 1, 2017
Results First Submitted that Met QC Criteria
Aug 1, 2017
Results First Posted Date
Feb 6, 2018Actual
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 9, 2021
Last Update Posted Date
Jun 14, 2021Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Neurocrine BiosciencesINDUSTRY
Collaborators
Name
Class
Takeda
INDUSTRY
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
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 study is to determine the safety, tolerability and pharmacokinetics (PK) of single and multiple rising doses of TAK-831 in healthy participants.
Detailed Description
The drug being tested in this study is called TAK-831. TAK-831 is being tested to treat participant who have schizophrenia and cerebellar ataxia. This study will look at the PK, safety and tolerability of TAK-831 in healthy participants. The study will enroll approximately 120 participants. The study will include 4 parts: Part 1 (single-rising dose [SRD]), Part 2 (SRD/multiple-rising dose [MRD]), Part 3 (MRD) and Part 4 (relative bioavailability study). Participants will be randomly assigned (by chance, like flipping a coin) to receive either active drug TAK-831 or placebo which will remain undisclosed to the participant and study doctor during the study (unless there is an urgent medical need):
Dosing with TAK-831 will progress into study Part 2, 3 and 4, only after review of all available safety, tolerability, and PK data collected in Cohorts 1 to 6 of the Study Part 1. This single center trial will be conducted in the United Kingdom. The overall time to participate in this study is approximately up to 58 days. Participants will be admitted in the clinic for the up to 20 days, and will be contacted by telephone 14 days after last dose of study drug for a follow-up assessment.
The study was terminated by Takeda due to the discomfort observed in the study participants from the CSF collection procedure in Part 3 of the study, hence it is was not feasible to collect further CSF samples that were required to meet the exploratory objectives of the study. Part 1, 2 and 4 of the study were completed as planned.
Conditions Module
Conditions
Schizophrenia, Cerebellar Ataxia
Keywords
Drug therapy
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
110Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Part 1, Cohort 1: TAK-831 100 mg
Experimental
TAK-831 100 milligram (mg), suspension, orally or TAK-831 placebo-matching suspension, orally, once on Day 1.
Drug: TAK-831 Oral Suspension
Drug: TAK-831 Placebo
Part 1, Cohort 2: TAK-831 250 mg
Experimental
TAK-831 250 mg, suspension, orally or TAK-831 placebo-matching suspension, orally, once on Day 1.
Drug: TAK-831 Oral Suspension
Drug: TAK-831 Placebo
Part 1, Cohort 3: TAK-831 500 mg
Experimental
TAK-831 500 mg, suspension, orally or TAK-831 placebo-matching suspension, orally, once on Day 1.
Drug: TAK-831 Oral Suspension
Drug: TAK-831 Placebo
Part 1, Cohort 4: TAK-831 30 mg
Experimental
TAK-831 30 mg, suspension, orally or TAK-831 placebo-matching suspension, orally, once on Day 1.
Drug: TAK-831 Oral Suspension
Drug: TAK-831 Placebo
Part 1, Cohort 5: TAK-831 750 mg
Experimental
TAK-831 750 mg, suspension, orally or TAK-831 placebo-matching suspension, orally, once on Day 1.
Interventions
Name
Type
Description
Arm Group Labels
Other Names
TAK-831 Oral Suspension
Drug
TAK-831 oral suspension.
Part 1, Cohort 1: TAK-831 100 mg
Part 1, Cohort 2: TAK-831 250 mg
Part 1, Cohort 3: TAK-831 500 mg
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Percentage of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE)
Baseline up to 30 days after the last dose of study drug (Part 1 Day 31, Part 2 Day 46, Part 3 Day 44 and Part 4 Day 43)
Percentage of Participants Who Meet the Markedly Abnormal Criteria for Safety Laboratory Tests at Least Once Post Dose
Clinical laboratory tests included hematology, serum chemistry and urinalysis.
Baseline up to Day 15 in Part 1, Day 30 in Part 2, Day 28 in Part 3 and Day 25 in Part 4
Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose
Markedly abnormal criteria for vital signs measurement was assessed. The lower criteria and upper criteria for abnormality are as follow: systolic blood pressure at less than (<) 85 millimeter of mercury (mm Hg) to greater than (>) 180 mm Hg; diastolic blood pressure < 50 mm Hg to >110 mm Hg; pulse rate <50 bpm to >120 bpm; Temperature <35.6 degree Celsius to >37.7 degree Celsius.
Baseline up to Day 15 in Part 1, Day 30 in Part 2, Day 28 in Part 3 and Day 25 in Part 4
Percentage of Participants Who Meet the Markedly Abnormal Criteria for Safety Electrocardiogram (ECG) Parameters at Least Once Post Dose
Markedly abnormal criteria for ECG was assessed. The lower cut-off point criteria and upper cut-off point criteria are as follow: heart rate <50 beats per minute (bpm) to >120 bpm; PR interval less than or equal to (<=) 80 millisecond (msec) to greater than or equal to (>=) 200 msec; QRS interval <=80 msec to >=180 msec; QT interval <=300 msec to >=460 msec; QTcB interval <=300 msec to >=500 msec or >=30 msec change from baseline and >=450 msec; QT interval with Fridericia's correction method (QTcF) interval <=50 msec to >=500 msec or >=30 msec change from baseline and >=450 msec.
Baseline up to Day 15 in Part 1, Day 30 in Part 2, Day 28 in Part 3 and Day 25 in Part 4
Secondary Outcomes
Measure
Description
Time Frame
Part 1, 2 and 4: Cmax: Maximum Observed Plasma Concentration for TAK-831
Day 1 pre-dose and at multiple time points (up to 96 hours in Part 1 and up to 72 hours in Part 2 and 4) post-dose
Part 2 and 3: Cmax, ss: Maximum Observed Plasma Concentration at Steady State for TAK-831
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Should be capable of understanding and complying with protocol requirements.
The participant or, when applicable, the participant's legally acceptable representative signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures.
Healthy male or female aged between 18 to 55 years- Weighing at least 45 kilogram (kg) and has a body mass index (BMI) from 18.0 to 30.0 kilogram per square meter (kg/m^2).
Male participant who is nonsterilized and sexually active with a female partner of childbearing potential agrees to use adequate contraception from signing of informed consent throughout the duration of the study and for 12 weeks after last dose.
Female participant with no childbearing potential, defined as a participant that has been surgically sterilized (hysterectomy, bilateral oophorectomy or tubal ligation) or who is post menopausal (defined as continuous amenorrhea of at least 2 years and follicle-stimulating hormone [FSH] greater than [>] 40 international units per liter [IU/L]).
Exclusion Criteria:
Received any investigational compound within 3 months prior to randomization.
Is an immediate family member, study site employee, or is in a dependent relationship with a study site employee who is involved in the conduct of this study (example, spouse, parent, child, sibling) or may consent under duress.
Has uncontrolled, clinically significant neurological (including seizure disorders), cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, urologic, immunologic, endocrine disease, or psychiatric disorder, or other abnormality.
Has a known hypersensitivity to any component of the formulation of TAK-831.
Female participant is of childbearing potential.
Has a positive urine drug result for drugs of abuse (defined as any illicit drug use) at Screening or Check-in.
History of drug abuse (defined as any illicit drug use) or a history of alcohol abuse within 1 year prior to the Screening visit or is unwilling to agree to abstain from alcohol and drugs throughout the study. One unit is equivalent to a half-pint of beer or 1 single measure of spirits or 1 small glass of wine.
Has taken any excluded medication, supplements, or food products during the time periods listed in the excluded medications and dietary products.
Female participant is pregnant or lactating or intending to become pregnant before, during, or within 1 month after participating in this study; or intending to donate ova during such time period.
Male participant intending to donate sperm during the course of this study or for 12 weeks after the last dose of study medication.
Has evidence of current cardiovascular, central nervous system, hepatic, hematopoietic disease, renal dysfunction, metabolic or endocrine dysfunction, serious allergy, asthma, hypoxemia, hypertension, seizures, or allergic skin rash.
Has a QT interval with Fridericia's correction method (QTcF) >450 millisecond (msec) (males) or >470 msec (females) or PR outside the range of 120 to 220 msec, confirmed with one repeat testing, at the screening visit or check-in (Day -2).
Has current or recent (within 6 months) gastrointestinal disease that would be expected to influence the absorption of drugs (that is, a history of malabsorption, esophageal reflux, peptic ulcer disease, erosive esophagitis, frequent [more than once per week] occurrence of heartburn, or any surgical intervention.
Has a history of cancer, except basal cell carcinoma which has been in remission for at least 5 years prior to Day 1.
Has a positive test result for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, or human immunodeficiency virus (HIV) antibody/antigen at Screening.
Has used nicotine-containing products (including but not limited to cigarettes, pipes, cigars, chewing tobacco, nicotine patch or nicotine gum) within 28 days prior to Check-in. Cotinine test is positive at Screening or Check-in.
Has poor peripheral venous access.
Has donated or lost 450 milliliter (mL) or more of his or her blood volume (including plasmapheresis), or had a transfusion of any blood product within 45 days prior to first dose of medication.
Has a Screening or Check-in abnormal (clinically significant) electrocardiogram (ECG). Entry of any participant with an abnormal (not clinically significant) ECG must be approved, and documented by signature by the principal investigator or designee.
Has a supine blood pressure outside the ranges of 90 to 140 millimeter of mercury (mm Hg) for systolic and 50 to 90 mm Hg for diastolic, confirmed on repeat testing within a maximum of 30 minutes, at the Screening Visit or Check-in.
Has a resting heart rate outside the range 40 to 100 bpm confirmed on repeat testing within a maximum of 30 minutes, at the Screening Visit or Check-in.
Has abnormal Screening or check-in laboratory values that suggest a clinically significant underlying disease or participant with the following lab abnormalities: Alanine transaminase (ALT) and/or aspartate aminotransferase (AST) >1.5 the upper limits of normal.
Has a risk of suicide according to the Investigator's clinical judgment (example, per The Columbia Suicide Severity Rating Scale [C-SSRS]), or has scored "yes" on item 4 or item 5 of the Suicidal Ideation section of the C-SSRS, if this ideation occurred in the past 6 months, or "yes" on any item of the Suicidal Behavior section, except for the "Non-Suicidal Self-Injurious Behavior", if this behaviour occurred in the past 2 years.
Has received TAK-831 in a previous clinical study.
Participant is vegan or vegetarian (Part 4 only - food effect).
Accepts Healthy Volunteers
Yes
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
55 Years
Standard Ages
Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Not provided
Locations
Facility
Status
City
State
ZIP
Country
Contacts
London
United Kingdom
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
Plan to Share IPD
No
Description
Not provided
Types
Not provided
Time Frame
Not provided
Access Criteria
Not provided
URL
Not provided
Healthy participants were enrolled in 4 part study to receive TAK-831: single rising dose (SRD) in Part 1; SRD/multiple rising dose (MRD) in Part 2; MRD in Part 3; relative bioavailability(rBA) in 3-sequence crossover in Part 4. Part 3 was terminated due to discomfort observed in participants from the cerebrospinal fluid (CSF) collection procedure.
Recruitment Details
Participants took part in the study at 1 investigative site in the United Kingdom from 23 September 2015 to 12 July 2016.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Part 1: Placebo Pooled
TAK-831 placebo-matching suspension, orally, once on Day 1.
FG001
Part 1: TAK-831 10 mg
TAK-831 10 milligram (mg), suspension, orally, once on Day 1.
FG002
Part 1: TAK-831 30 mg
TAK-831 30 mg, suspension, orally, once on Day 1.
FG003
Part 1: TAK-831 100 mg
TAK-831 100 mg, suspension, orally, once on Day 1.
FG004
Part 1: TAK-831 250 mg
TAK-831 250 mg, suspension, orally, once on Day 1.
FG005
Part 1: TAK-831 500 mg
TAK-831 500 mg, suspension, orally, once on Day 1.
FG006
Part 1: TAK-831 750 mg
TAK-831 750 mg, suspension, orally, once on Day 1.
FG007
Part 2: Placebo Pooled
TAK-831 placebo-matching suspension, orally, once on Day 1 and Days 4-16.
FG008
Part 2: TAK-831 30 mg
TAK-831 30 mg, suspension, orally, once on Day 1 and Days 4-16.
FG009
Part 2: TAK-831 100 mg
TAK-831 100 mg, suspension, orally, once on Day 1 and Days 4-16.
FG010
Part 2: TAK-831 200 mg
TAK-831 200 mg, suspension, orally, once on Day 1 and Days 4-16.
FG011
Part 2: TAK-831 400 mg
TAK-831 400 mg, suspension, orally, once on Day 1 and Days 4-16.
FG012
Part 3: Placebo
TAK-831 placebo-matching suspension, orally, once daily on Days 1-14.
FG013
Part 3: TAK-831 400 mg
TAK-831 400 mg, suspension, orally, once daily from Days 1-14.
FG014
Part 4: TAK-831 (Tablet Fasted+Tablet Fed+Suspension Fasted)
TAK-831 100 mg, tablet, orally, in fasted state, once on Day 1 of Period 1, followed by a 5-day washout period, further followed by TAK-831 100 mg, tablet, orally, in fed state, once on Day 1 of Period 2, followed by a 5-day washout period, further followed by TAK-831 100 mg, suspension, orally, in fasted state, once on Day 1 of Period 3.
FG015
Part 4: TAK-831 (Tablet Fed+Tablet Fasted+Suspension Fasted)
TAK-831 100 mg, tablet, orally, in fed state, once on Day 1 of Period 1, followed by a 5-day washout period, further followed by TAK-831 100 mg, tablet, orally, in fasted state, once on Day 1 of Period 2, followed by a 5-day washout period, further followed by TAK-831 100 mg, suspension, orally, in fasted state, once on Day 1 of Period 3.
FG016
Part 4: TAK-831 (Suspension Fasted+Tablet Fed+Tablet Fasted)
TAK-831 100 mg, suspension, orally, in fasted state, once on Day 1 of Period 1, followed by a 5-day washout period, further followed by TAK-831 100 mg, tablet, orally, in fed state, once on Day 1 of Period 2, followed by a 5-day washout interval, further followed by TAK-831 100 mg, tablet, orally, in fasted state, once on Day 1 of Period 3.
Periods
Title
Milestones
Reasons Not Completed
All Parts
Type
Comment
Milestone Data
STARTED
FG00012 subjects
FG0016 subjects
FG0026 subjects
FG0036 subjects
FG0046 subjects
FG0056 subjects
FG0066 subjects
FG0078 subjects
FG0086 subjects
FG0096 subjects
FG0106 subjects
FG0116 subjects
FG0121 subjects
FG0135 subjects
FG0148 subjects
FG0158 subjects
FG0168 subjects
COMPLETED
FG00012 subjectsParticipants from Part 1 and 2 did not continue in the washout period of Part 4 (crossover part).
FG0015 subjectsParticipants from Part 1 and 2 did not continue in the washout period of Part 4 (crossover part).
FG0026 subjectsParticipants from Part 1 and 2 did not continue in the washout period of Part 4 (crossover part).
FG003
NOT COMPLETED
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Withdrawal by Subject
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG003
Washout Crossover Period (Part 4:5 Days)
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Crossover Treatment (Part 4: 1 Day)
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Washout Crossover Period (Part 4:5 Days)
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Crossover Treatment (Part 4: 1 Day)
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Baseline Characteristics Module
Baseline Analysis Population Description
The safety set included all participants who received at least 1 dose of study drug.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Part 1: Placebo Pooled
TAK-831 placebo-matching suspension, orally, once on Day 1.
BG001
Part 1: TAK-831 10 mg
TAK-831 10 milligram (mg), suspension, orally, once on Day 1.
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
Number
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
Percentage of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE)
The safety set included all participants who received at least 1 dose of study drug.
Posted
Number
percentage of participants
Baseline up to 30 days after the last dose of study drug (Part 1 Day 31, Part 2 Day 46, Part 3 Day 44 and Part 4 Day 43)
ID
Title
Description
OG000
Part 1: Placebo Pooled
TAK-831 placebo-matching suspension, orally, once on Day 1.
OG001
Part 1: TAK-831 10 mg
TAK-831 10 milligram (mg), suspension, orally, once on Day 1.
OG002
Adverse Events Module
Frequency Threshold
0
Time Frame
Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (Part 1 Day 31, Part 2 Day 46, Part 3 Day 44 and Part 4 Day 43)
Description
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
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
Part 1: Placebo Pooled
TAK-831 placebo-matching suspension, orally, once on Day 1.
Serious Adverse Events
Not provided
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Nausea
Gastrointestinal disorders
MedDRA (19.0)
Systematic Assessment
More Info Module
Limitations and Caveats
Not provided
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
Point of Contact
Title
Organization
Phone
Extension
Email
Neurocrine Medical Information
Neurocrine Biosciences
877-641-3461
medinfo@neurocrine.com
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
ID
Term
D012559
Schizophrenia
D002524
Cerebellar Ataxia
Ancestor Terms
ID
Term
D019967
Schizophrenia Spectrum and Other Psychotic Disorders
D001523
Mental Disorders
D002526
Cerebellar Diseases
D001927
Brain Diseases
Browse Leaves
Not provided
Browse Branches
Not provided
Intervention Browse Module
No data available
No data is available for this block.
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Other
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Double
Masking Description
Not provided
Who Masked
ParticipantInvestigator
Drug: TAK-831 Oral Suspension
Drug: TAK-831 Placebo
Part 1, Cohort 6: TAK-831 10 mg
Experimental
TAK-831 10 mg, suspension, orally or TAK-831 placebo-matching suspension, orally, once on Day 1.
Drug: TAK-831 Oral Suspension
Drug: TAK-831 Placebo
Part 2, Cohort 1: TAK-831 30 mg
Experimental
TAK-831 30 mg, suspension, orally or TAK-831 placebo-matching suspension, orally, once on Day 1 and once daily from Days 4 to 16.
Drug: TAK-831 Oral Suspension
Drug: TAK-831 Placebo
Part 2, Cohort 2: TAK-831 100 mg
Experimental
TAK-831 100 mg, suspension, orally or TAK-831 placebo-matching suspension, orally, once on Day 1 and once daily from Days 4 to 16.
Drug: TAK-831 Oral Suspension
Drug: TAK-831 Placebo
Part 2, Cohort 3: TAK-831 200 mg
Experimental
TAK-831 200 mg, suspension, orally or TAK-831 placebo-matching suspension, orally, once on Day 1 and once daily from Days 4 to 16.
Drug: TAK-831 Oral Suspension
Drug: TAK-831 Placebo
Part 2, Cohort 4: TAK-831 400 mg
Experimental
TAK-831 400 mg, suspension, orally or TAK-831 placebo-matching suspension, orally, once on Day 1 and once daily from Days 4 to 16.
Drug: TAK-831 Oral Suspension
Drug: TAK-831 Placebo
Part 3, Cohort 1: TAK-831 400 mg
Experimental
TAK-831 400 mg, suspension, orally or TAK-831 placebo-matching suspension, orally, once daily from Days 1 to 14.
Drug: TAK-831 Oral Suspension
Drug: TAK-831 Placebo
Part 4:TAK-831(Tablet Fasted+ Tablet Fed + Suspension Fasted)
Experimental
TAK-831 100 mg, tablet, orally, once after an overnight fast of at least 10 hours on Day 1 of Period 1, followed by a washout interval of 5 days, further followed by TAK-831 100 mg, tablet, orally, once 30 minutes after starting a high fat meal on Day 1 of Period 2, followed by a washout interval of 5 days, further followed by TAK-831 100 mg, suspension, orally, once after an overnight fast of at least 10 hours on Day 1 of Period 3.
Drug: TAK-831 Oral Suspension
Drug: TAK-831 Tablet
Part 4:TAK-831(Tablet Fed + Tablet Fasted + Suspension Fasted)
Experimental
TAK-831 100 mg, tablet, orally, once 30 minutes after starting a high fat meal on Day 1 of Period 1, followed by a washout interval of 5 days, further followed by TAK-831 100 mg, tablet, orally, once after an overnight fast of at least 10 hours on Day 1 of Period 2, followed by a washout interval of 5 days, further followed by TAK-831 100 mg, suspension, orally, once after an overnight fast of at least 10 hours on Day 1 of Period 3.
Drug: TAK-831 Oral Suspension
Drug: TAK-831 Tablet
Part 4:TAK-831(Suspension Fasted+ Tablet Fed + Tablet Fasted)
Experimental
TAK-831 100 mg, suspension, orally, once after an overnight fast of at least 10 hours on Day 1 of Period 1, followed by a washout interval of 5 days, further followed by TAK-831 100 mg, tablet, orally, once 30 minutes after starting a high fat meal on Day 1 of Period 2, followed by a washout interval of 5 days, further followed by TAK-831 100 mg, tablet, orally, once after an overnight fast of at least 10 hours on Day 1 of Period 3.
Drug: TAK-831 Oral Suspension
Drug: TAK-831 Tablet
Part 1, Cohort 4: TAK-831 30 mg
Part 1, Cohort 5: TAK-831 750 mg
Part 1, Cohort 6: TAK-831 10 mg
Part 2, Cohort 1: TAK-831 30 mg
Part 2, Cohort 2: TAK-831 100 mg
Part 2, Cohort 3: TAK-831 200 mg
Part 2, Cohort 4: TAK-831 400 mg
Part 3, Cohort 1: TAK-831 400 mg
Part 4:TAK-831(Suspension Fasted+ Tablet Fed + Tablet Fasted)
Part 4:TAK-831(Tablet Fasted+ Tablet Fed + Suspension Fasted)
Part 4:TAK-831(Tablet Fed + Tablet Fasted + Suspension Fasted)
TAK-831 Placebo
Drug
TAK-831 placebo-matching oral suspension.
Part 1, Cohort 1: TAK-831 100 mg
Part 1, Cohort 2: TAK-831 250 mg
Part 1, Cohort 3: TAK-831 500 mg
Part 1, Cohort 4: TAK-831 30 mg
Part 1, Cohort 5: TAK-831 750 mg
Part 1, Cohort 6: TAK-831 10 mg
Part 2, Cohort 1: TAK-831 30 mg
Part 2, Cohort 2: TAK-831 100 mg
Part 2, Cohort 3: TAK-831 200 mg
Part 2, Cohort 4: TAK-831 400 mg
Part 3, Cohort 1: TAK-831 400 mg
TAK-831 Tablet
Drug
TAK-831 tablet.
Part 4:TAK-831(Suspension Fasted+ Tablet Fed + Tablet Fasted)
Part 4:TAK-831(Tablet Fasted+ Tablet Fed + Suspension Fasted)
Part 4:TAK-831(Tablet Fed + Tablet Fasted + Suspension Fasted)
Day 16 (Part 2) and Day 14 (Part 3) pre-dose and at multiple time points (up to 24 hours) post-dose
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-831
Day 1 pre-dose and at multiple time points (up to 96 hours in Part 1 and up to 72 hours in Part 2 and 4) post-dose; Day 16 (Part 2) and Day 14 (Part 3) pre-dose and at multiple time points (up to 24 hours) post-dose
Part 1, 2 and 4: AUCt: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-831
Day 1 pre-dose and at multiple time points (up to 96 hours in Part 1 and up to 72 hours in Part 2 and 4) post-dose
Part 1, 2 and 4: AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-831
Day 1 pre-dose and at multiple time points (up to 96 hours in Part 1 and up to 72 hours in Part 2 and 4) post-dose
Part 2 and 3: AUCτ: Area Under the Plasma Concentration-time Curve From Time 0 to Time Tau Over the Dosing Interval for TAK-831
Day 16 (Part 2) and Day 14 (Part 3) pre-dose and at multiple time points (up to 24 hours) post-dose
6 subjects
Participants from Part 1 and 2 did not continue in the washout period of Part 4 (crossover part).
FG0046 subjectsParticipants from Part 1 and 2 did not continue in the washout period of Part 4 (crossover part).
FG0056 subjectsParticipants from Part 1 and 2 did not continue in the washout period of Part 4 (crossover part).
FG0066 subjectsParticipants from Part 1 and 2 did not continue in the washout period of Part 4 (crossover part).
FG0078 subjectsParticipants from Part 1 and 2 did not continue in the washout period of Part 4 (crossover part).
FG0086 subjectsParticipants from Part 1 and 2 did not continue in the washout period of Part 4 (crossover part).
FG0096 subjectsParticipants from Part 1 and 2 did not continue in the washout period of Part 4 (crossover part).
FG0106 subjectsParticipants from Part 1 and 2 did not continue in the washout period of Part 4 (crossover part).
FG0116 subjectsParticipants from Part 1 and 2 did not continue in the washout period of Part 4 (crossover part).
FG0120 subjects
FG0130 subjects
FG0148 subjectsOnly participants of Part 4 continued in next period.
FG0158 subjectsOnly participants of Part 4 continued in next period.
FG0168 subjectsOnly participants of Part 4 continued in next period.
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0121 subjects
FG0135 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
0 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0121 subjects
FG0133 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
Other
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0132 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
0 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0148 subjects
FG0158 subjects
FG0168 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0148 subjects
FG0158 subjects
FG0168 subjects
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
0 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0148 subjects
FG0158 subjects
FG0168 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0148 subjects
FG0158 subjects
FG0167 subjects
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0161 subjects
Type
Comment
Reasons
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0161 subjects
0 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0148 subjects
FG0158 subjects
FG0167 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0148 subjects
FG0158 subjects
FG0167 subjects
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
0 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0148 subjects
FG0158 subjects
FG0167 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0148 subjects
FG0158 subjects
FG0167 subjects
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
BG002
Part 1: TAK-831 30 mg
TAK-831 30 mg, suspension, orally, once on Day 1.
BG003
Part 1: TAK-831 100 mg
TAK-831 100 mg, suspension, orally, once on Day 1.
BG004
Part 1: TAK-831 250 mg
TAK-831 250 mg, suspension, orally, once on Day 1.
BG005
Part 1: TAK-831 500 mg
TAK-831 500 mg, suspension, orally, once on Day 1.
BG006
Part 1: TAK-831 750 mg
TAK-831 750 mg, suspension, orally, once on Day 1.
BG007
Part 2: Placebo Pooled
TAK-831 placebo-matching suspension, orally, once on Day 1 and Days 4-16.
BG008
Part 2: TAK-831 30 mg
TAK-831 30 mg, suspension, orally, once on Day 1 and Days 4-16.
BG009
Part 2: TAK-831 100 mg
TAK-831 100 mg, suspension, orally, once on Day 1 and Days 4-16.
BG010
Part 2: TAK-831 200 mg
TAK-831 200 mg, suspension, orally, once on Day 1 and Days 4-16.
BG011
Part 2: TAK-831 400 mg
TAK-831 400 mg, suspension, orally, once on Day 1 and Days 4-16.
BG012
Part 3: Placebo
TAK-831 placebo-matching suspension, orally, once daily on Days 1-14.
BG013
Part 3: TAK-831 400 mg
TAK-831 400 mg, suspension, orally, once daily from Days 1-14.
BG014
Part 4: TAK-831 (Tablet Fasted+Tablet Fed+Suspension Fasted)
TAK-831 100 mg, tablet, orally, in fasted state, once on Day 1 of Period 1, followed by a 5-day washout period, further followed by TAK-831 100 mg, tablet, orally, in fed state, once on Day 1 of Period 2, followed by a 5-day washout period, further followed by TAK-831 100 mg, suspension, orally, in fasted state, once on Day 1 of Period 3.
BG015
Part 4: TAK-831 (Tablet Fed+Tablet Fasted+Suspension Fasted)
TAK-831 100 mg, tablet, orally, in fed state, once on Day 1 of Period 1, followed by a 5-day washout period, further followed by TAK-831 100 mg, tablet, orally, in fasted state, once on Day 1 of Period 2, followed by a 5-day washout period, further followed by TAK-831 100 mg, suspension, orally, in fasted state, once on Day 1 of Period 3.
BG016
Part 4: TAK-831 (Suspension Fasted+Tablet Fed+Tablet Fasted)
TAK-831 100 mg, suspension, orally, in fasted state, once on Day 1 of Period 1, followed by a 5-day washout period, further followed by TAK-831 100 mg, tablet, orally, in fed state, once on Day 1 of Period 2, followed by a 5-day washout interval, further followed by TAK-831 100 mg, tablet, orally, in fasted state, once on Day 1 of Period 3.
BG017
Total
Total of all reporting groups
12
BG0016
BG0026
BG0036
BG0046
BG0056
BG0066
BG0078
BG0086
BG0096
BG0106
BG0116
BG0121
BG0135
BG0148
BG0158
BG0168
BG017110
participants
Title
Denominators
Categories
18 to 55 years
Title
Measurements
BG00012
BG0016
BG0026
BG0036
BG0046
BG0056
BG0066
BG0078
BG0086
BG0096
BG0106
BG0116
BG0121
BG0135
BG0148
BG0158
BG0168
BG017110
Sex/Gender, Customized
Number
participants
Title
Denominators
Categories
Male
Title
Measurements
BG00012
BG0016
BG0026
BG0036
BG0046
BG0056
BG0066
BG0078
BG0086
BG0096
BG0106
BG0116
BG0121
BG0135
BG0148
BG0158
BG0168
BG017110
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
BG0110
BG0120
BG0130
BG0140
BG0150
BG0160
BG0170
Asian
BG0002
BG0010
BG0021
BG0030
BG004
Native Hawaiian or Other Pacific Islander
BG0000
BG0010
BG0020
BG0030
BG004
Black or African American
BG0000
BG0011
BG0020
BG0031
BG004
White
BG00010
BG0015
BG0025
BG0035
BG004
More than one race
BG0000
BG0010
BG0020
BG0030
BG004
Unknown or Not Reported
BG0000
BG0010
BG0020
BG0030
BG004
Region of Enrollment
Number
participants
Title
Denominators
Categories
United Kingdom
Title
Measurements
BG00012
BG0016
BG0026
BG0036
BG0046
BG0056
BG0066
BG0078
BG0086
BG0096
BG0106
BG0116
BG0121
BG0135
BG0148
BG0158
BG0168
BG017110
Smoking History
Number
participants
Title
Denominators
Categories
Never smoked
Title
Measurements
BG0008
BG0014
BG0025
BG0035
BG0043
BG0053
BG0066
BG0075
BG0085
BG0095
BG0104
BG0115
BG0121
BG0134
BG0148
BG0155
BG0166
BG01782
Ex-smoker
Title
Measurements
BG0004
BG0012
BG0021
BG003
Alcohol history
Number
participants
Title
Denominators
Categories
Never drunk
Title
Measurements
BG0003
BG0011
BG0023
BG0032
BG0041
BG0051
BG0064
BG0073
BG0084
BG0093
BG0100
BG0110
BG0121
BG0133
BG0142
BG0151
BG0161
BG01733
Current drinker
Title
Measurements
BG0009
BG0015
BG0023
BG003
Caffeine Consumption
Number
participants
Title
Denominators
Categories
Caffeine consumption
Title
Measurements
BG00010
BG0016
BG0024
BG0035
BG0045
BG0054
BG0066
BG0073
BG0083
BG0094
BG0104
BG0114
BG0121
BG0133
BG0148
BG0154
BG0164
BG01778
No caffeine consumption
Title
Measurements
BG0002
BG0010
BG0022
BG003
Part 1: TAK-831 30 mg
TAK-831 30 mg, suspension, orally, once on Day 1.
OG003
Part 1: TAK-831 100 mg
TAK-831 100 mg, suspension, orally, once on Day 1.
OG004
Part 1: TAK-831 250 mg
TAK-831 250 mg, suspension, orally, once on Day 1.
OG005
Part 1: TAK-831 500 mg
TAK-831 500 mg, suspension, orally, once on Day 1.
OG006
Part 1: TAK-831 750 mg
TAK-831 750 mg, suspension, orally, once on Day 1.
OG007
Part 2: Placebo Pooled
TAK-831 placebo-matching suspension, orally, once on Day 1 and Days 4-16.
OG008
Part 2: TAK-831 30 mg
TAK-831 30 mg, suspension, orally, once on Day 1 and Days 4-16.
OG009
Part 2: TAK-831 100 mg
TAK-831 100 mg, suspension, orally, once on Day 1 and Days 4-16.
OG010
Part 2: TAK-831 200 mg
TAK-831 200 mg, suspension, orally, once on Day 1 and Days 4-16.
OG011
Part 2: TAK-831 400 mg
TAK-831 400 mg, suspension, orally, once on Day 1 and Days 4-16.
OG012
Part 3: Placebo
TAK-831 placebo-matching suspension, orally, once daily on Days 1-14.
OG013
Part 3: TAK-831 400 mg
TAK-831 400 mg, suspension, orally, once daily from Days 1-14.
OG014
Part 4: TAK-831 100 mg Tablet Fasted
TAK-831 100 mg, tablet, orally, once in fasted state on Day 1 of either Period 1, 2 or 3.
OG015
Part 4: TAK-831 100 mg Tablet Fed
TAK-831 100 mg, tablet, orally, once in fed state on Day 1 of either Period 1, 2 or 3.
OG016
Part 4: TAK-831 100 mg Suspension Fasted
TAK-831 100 mg, suspension, orally, once in fasted state on Day 1 of either Period 1, 2 or 3.
Units
Counts
Participants
OG00012
OG0016
OG0026
OG0036
OG0046
OG0056
OG0066
OG0078
OG0086
OG0096
OG0106
OG0116
OG0121
OG0135
OG01423
OG01523
OG01624
Title
Denominators
Categories
Title
Measurements
OG00050.0
OG00133.3
OG00233.3
OG00333.3
OG00416.7
OG00550.0
OG00666.7
OG00775.0
OG00883.3
OG009100.0
OG01033.3
OG01183.3
OG012100.0
OG013100.0
OG01421.7
OG01513.0
OG01616.7
Primary
Percentage of Participants Who Meet the Markedly Abnormal Criteria for Safety Laboratory Tests at Least Once Post Dose
Clinical laboratory tests included hematology, serum chemistry and urinalysis.
The safety set included all participants who received at least 1 dose of study drug.
Posted
Number
percentage of participants
Baseline up to Day 15 in Part 1, Day 30 in Part 2, Day 28 in Part 3 and Day 25 in Part 4
ID
Title
Description
OG000
Part 1: Placebo Pooled
TAK-831 placebo-matching suspension, orally, once on Day 1.
OG001
Part 1: TAK-831 10 mg
TAK-831 10 milligram (mg), suspension, orally, once on Day 1.
OG002
Part 1: TAK-831 30 mg
TAK-831 30 mg, suspension, orally, once on Day 1.
OG003
Part 1: TAK-831 100 mg
TAK-831 100 mg, suspension, orally, once on Day 1.
OG004
Part 1: TAK-831 250 mg
TAK-831 250 mg, suspension, orally, once on Day 1.
OG005
Part 1: TAK-831 500 mg
TAK-831 500 mg, suspension, orally, once on Day 1.
OG006
Part 1: TAK-831 750 mg
TAK-831 750 mg, suspension, orally, once on Day 1.
OG007
Part 2: Placebo Pooled
TAK-831 placebo-matching suspension, orally, once on Day 1 and Days 4-16.
OG008
Part 2: TAK-831 30 mg
TAK-831 30 mg, suspension, orally, once on Day 1 and Days 4-16.
OG009
Part 2: TAK-831 100 mg
TAK-831 100 mg, suspension, orally, once on Day 1 and Days 4-16.
OG010
Part 2: TAK-831 200 mg
TAK-831 200 mg, suspension, orally, once on Day 1 and Days 4-16.
OG011
Part 2: TAK-831 400 mg
TAK-831 400 mg, suspension, orally, once on Day 1 and Days 4-16.
OG012
Part 3: Placebo
TAK-831 placebo-matching suspension, orally, once daily on Days 1-14.
OG013
Part 3: TAK-831 400 mg
TAK-831 400 mg, suspension, orally, once daily from Days 1-14.
OG014
Part 4: TAK-831 100 mg Tablet Fasted
TAK-831 100 mg, tablet, orally, once in fasted state on Day 1 of either Period 1, 2 or 3.
OG015
Part 4: TAK-831 100 mg Tablet Fed
TAK-831 100 mg, tablet, orally, once in fed state on Day 1 of either Period 1, 2 or 3.
OG016
Part 4: TAK-831 100 mg Suspension Fasted
TAK-831 100 mg, suspension, orally, once in fasted state on Day 1 of either Period 1, 2 or 3.
Units
Counts
Participants
OG00012
OG0016
OG0026
OG003
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG003
Primary
Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose
Markedly abnormal criteria for vital signs measurement was assessed. The lower criteria and upper criteria for abnormality are as follow: systolic blood pressure at less than (<) 85 millimeter of mercury (mm Hg) to greater than (>) 180 mm Hg; diastolic blood pressure < 50 mm Hg to >110 mm Hg; pulse rate <50 bpm to >120 bpm; Temperature <35.6 degree Celsius to >37.7 degree Celsius.
The safety set included all participants who received at least 1 dose of study drug.
Posted
Number
percentage of participants
Baseline up to Day 15 in Part 1, Day 30 in Part 2, Day 28 in Part 3 and Day 25 in Part 4
ID
Title
Description
OG000
Part 1: Placebo Pooled
TAK-831 placebo-matching suspension, orally, once on Day 1.
OG001
Part 1: TAK-831 10 mg
TAK-831 10 milligram (mg), suspension, orally, once on Day 1.
OG002
Part 1: TAK-831 30 mg
TAK-831 30 mg, suspension, orally, once on Day 1.
OG003
Part 1: TAK-831 100 mg
TAK-831 100 mg, suspension, orally, once on Day 1.
OG004
Part 1: TAK-831 250 mg
TAK-831 250 mg, suspension, orally, once on Day 1.
OG005
Part 1: TAK-831 500 mg
TAK-831 500 mg, suspension, orally, once on Day 1.
OG006
Part 1: TAK-831 750 mg
TAK-831 750 mg, suspension, orally, once on Day 1.
OG007
Part 2: Placebo Pooled
TAK-831 placebo-matching suspension, orally, once on Day 1 and Days 4-16.
OG008
Part 2: TAK-831 30 mg
TAK-831 30 mg, suspension, orally, once on Day 1 and Days 4-16.
OG009
Part 2: TAK-831 100 mg
TAK-831 100 mg, suspension, orally, once on Day 1 and Days 4-16.
OG010
Part 2: TAK-831 200 mg
TAK-831 200 mg, suspension, orally, once on Day 1 and Days 4-16.
OG011
Part 2: TAK-831 400 mg
TAK-831 400 mg, suspension, orally, once on Day 1 and Days 4-16.
OG012
Part 3: Placebo
TAK-831 placebo-matching suspension, orally, once daily on Days 1-14.
OG013
Part 3: TAK-831 400 mg
TAK-831 400 mg, suspension, orally, once daily from Days 1-14.
OG014
Part 4: TAK-831 100 mg Tablet Fasted
TAK-831 100 mg, tablet, orally, once in fasted state on Day 1 of either Period 1, 2 or 3.
OG015
Part 4: TAK-831 100 mg Tablet Fed
TAK-831 100 mg, tablet, orally, once in fed state on Day 1 of either Period 1, 2 or 3.
OG016
Part 4: TAK-831 100 mg Suspension Fasted
TAK-831 100 mg, suspension, orally, once in fasted state on Day 1 of either Period 1, 2 or 3.
Units
Counts
Participants
OG00012
OG0016
OG0026
OG003
Title
Denominators
Categories
< lower criteria
Title
Measurements
OG00050.0
OG00150.0
OG00216.7
OG003
Primary
Percentage of Participants Who Meet the Markedly Abnormal Criteria for Safety Electrocardiogram (ECG) Parameters at Least Once Post Dose
Markedly abnormal criteria for ECG was assessed. The lower cut-off point criteria and upper cut-off point criteria are as follow: heart rate <50 beats per minute (bpm) to >120 bpm; PR interval less than or equal to (<=) 80 millisecond (msec) to greater than or equal to (>=) 200 msec; QRS interval <=80 msec to >=180 msec; QT interval <=300 msec to >=460 msec; QTcB interval <=300 msec to >=500 msec or >=30 msec change from baseline and >=450 msec; QT interval with Fridericia's correction method (QTcF) interval <=50 msec to >=500 msec or >=30 msec change from baseline and >=450 msec.
The safety set included all participants who received at least 1 dose of study drug.
Posted
Number
percentage of participants
Baseline up to Day 15 in Part 1, Day 30 in Part 2, Day 28 in Part 3 and Day 25 in Part 4
ID
Title
Description
OG000
Part 1: Placebo Pooled
TAK-831 placebo-matching suspension, orally, once on Day 1.
OG001
Part 1: TAK-831 10 mg
TAK-831 10 milligram (mg), suspension, orally, once on Day 1.
OG002
Part 1: TAK-831 30 mg
TAK-831 30 mg, suspension, orally, once on Day 1.
OG003
Part 1: TAK-831 100 mg
TAK-831 100 mg, suspension, orally, once on Day 1.
OG004
Part 1: TAK-831 250 mg
TAK-831 250 mg, suspension, orally, once on Day 1.
OG005
Part 1: TAK-831 500 mg
TAK-831 500 mg, suspension, orally, once on Day 1.
OG006
Part 1: TAK-831 750 mg
TAK-831 750 mg, suspension, orally, once on Day 1.
OG007
Part 2: Placebo Pooled
TAK-831 placebo-matching suspension, orally, once on Day 1 and Days 4-16.
OG008
Part 2: TAK-831 30 mg
TAK-831 30 mg, suspension, orally, once on Day 1 and Days 4-16.
OG009
Part 2: TAK-831 100 mg
TAK-831 100 mg, suspension, orally, once on Day 1 and Days 4-16.
OG010
Part 2: TAK-831 200 mg
TAK-831 200 mg, suspension, orally, once on Day 1 and Days 4-16.
OG011
Part 2: TAK-831 400 mg
TAK-831 400 mg, suspension, orally, once on Day 1 and Days 4-16.
OG012
Part 3: Placebo
TAK-831 placebo-matching suspension, orally, once daily on Days 1-14.
OG013
Part 3: TAK-831 400 mg
TAK-831 400 mg, suspension, orally, once daily from Days 1-14.
OG014
Part 4: TAK-831 100 mg Tablet Fasted
TAK-831 100 mg, tablet, orally, once in fasted state on Day 1 of either Period 1, 2 or 3.
OG015
Part 4: TAK-831 100 mg Tablet Fed
TAK-831 100 mg, tablet, orally, once in fed state on Day 1 of either Period 1, 2 or 3.
OG016
Part 4: TAK-831 100 mg Suspension Fasted
TAK-831 100 mg, suspension, orally, once in fasted state on Day 1 of either Period 1, 2 or 3.
Units
Counts
Participants
OG00012
OG0016
OG0026
OG003
Title
Denominators
Categories
< lower cut-off point criteria
Title
Measurements
OG00041.7
OG00133.3
OG00216.7
OG003
Secondary
Part 1, 2 and 4: Cmax: Maximum Observed Plasma Concentration for TAK-831
The PK set included all participants with at least 1 estimable PK parameter for TAK-831.
Posted
Mean
Standard Deviation
nanogram per milliliter (ng/mL)
Day 1 pre-dose and at multiple time points (up to 96 hours in Part 1 and up to 72 hours in Part 2 and 4) post-dose
ID
Title
Description
OG000
Part 1: TAK-831 10 mg
TAK-831 10 milligram (mg), suspension, orally, once on Day 1.
OG001
Part 1: TAK-831 30 mg
TAK-831 30 mg, suspension, orally, once on Day 1.
OG002
Part 1: TAK-831 100 mg
TAK-831 100 mg, suspension, orally, once on Day 1.
OG003
Part 1: TAK-831 250 mg
TAK-831 250 mg, suspension, orally, once on Day 1.
OG004
Part 1: TAK-831 500 mg
TAK-831 500 mg, suspension, orally, once on Day 1.
OG005
Part 1: TAK-831 750 mg
TAK-831 750 mg, suspension, orally, once on Day 1.
OG006
Part 2: TAK-831 30 mg
TAK-831 30 mg, suspension, orally, once on Day 1 and Days 4-16.
OG007
Part 2: TAK-831 100 mg
TAK-831 100 mg, suspension, orally, once on Day 1 and Days 4-16.
OG008
Part 2: TAK-831 200 mg
TAK-831 200 mg, suspension, orally, once on Day 1 and Days 4-16.
OG009
Part 2: TAK-831 400 mg
TAK-831 400 mg, suspension, orally, once on Day 1 and Days 4-16.
OG010
Part 4: TAK-831 100 mg Tablet Fasted
TAK-831 100 mg, tablet, orally, once in fasted state on Day 1 of either Period 1, 2 or 3.
OG011
Part 4: TAK-831 100 mg Tablet Fed
TAK-831 100 mg, tablet, orally, once in fed state on Day 1 of either Period 1, 2 or 3.
OG012
Part 4: TAK-831 100 mg Suspension Fasted
TAK-831 100 mg, suspension, orally, once in fasted state on Day 1 of either Period 1, 2 or 3.
Units
Counts
Participants
OG0006
OG0016
OG0026
OG003
Title
Denominators
Categories
Title
Measurements
OG00090.7± 26.95
OG001313.3± 121.97
OG002567.7± 218.76
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
OG000
OG001
OG002
OG003
OG004
OG005
Dose proportionality was evaluated using the following power model: ln (PK Parameter) is equal to (=) a+b*ln (dose), where a and b are the intercept and slope of the line, respectively. Dose proportionality was declared when the 90 percent (%) confidence interval (CI) of the slope lies entirely within the critical region (0.9483, 1.0517) for the dose range of 10 mg to 750 mg.
Slope
0.6662
2-Sided
90
0.5969
0.7355
Superiority or Other (legacy)
Secondary
Part 2 and 3: Cmax, ss: Maximum Observed Plasma Concentration at Steady State for TAK-831
The PK set included all participants with at least 1 estimable PK parameter for TAK-831. Due to discomfort observed in participants from the CSF collection procedure, Part 3 of the study was terminated hence no participants were analyzed.
Posted
Mean
Standard Deviation
ng/mL
Day 16 (Part 2) and Day 14 (Part 3) pre-dose and at multiple time points (up to 24 hours) post-dose
ID
Title
Description
OG000
Part 2: TAK-831 30 mg
TAK-831 30 mg, suspension, orally, once on Day 1 and Days 4-16.
OG001
Part 2: TAK-831 100 mg
TAK-831 100 mg, suspension, orally, once on Day 1 and Days 4-16.
OG002
Part 2: TAK-831 200 mg
TAK-831 200 mg, suspension, orally, once on Day 1 and Days 4-16.
OG003
Part 2: TAK-831 400 mg
TAK-831 400 mg, suspension, orally, once on Day 1 and Days 4-16.
OG004
Part 3: TAK-831 400 mg
TAK-831 400 mg, suspension, orally, once daily from Days 1-14.
Units
Counts
Participants
OG0006
OG0016
OG0026
OG003
Title
Denominators
Categories
Title
Measurements
OG000177.5± 45.85
OG001560.7± 214.90
OG002897.7± 192.73
OG003
Secondary
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-831
The PK set included all participants with at least 1 estimable PK parameter for TAK-831. Due to discomfort observed in participants from the CSF collection procedure, Part 3 of the study was terminated hence no participants were analyzed.
Posted
Median
Full Range
hours
Day 1 pre-dose and at multiple time points (up to 96 hours in Part 1 and up to 72 hours in Part 2 and 4) post-dose; Day 16 (Part 2) and Day 14 (Part 3) pre-dose and at multiple time points (up to 24 hours) post-dose
ID
Title
Description
OG000
Part 1: TAK-831 10 mg
TAK-831 10 milligram (mg), suspension, orally, once on Day 1.
OG001
Part 1: TAK-831 30 mg
TAK-831 30 mg, suspension, orally, once on Day 1.
OG002
Part 1: TAK-831 100 mg
TAK-831 100 mg, suspension, orally, once on Day 1.
OG003
Part 1: TAK-831 250 mg
TAK-831 250 mg, suspension, orally, once on Day 1.
OG004
Part 1: TAK-831 500 mg
TAK-831 500 mg, suspension, orally, once on Day 1.
OG005
Part 1: TAK-831 750 mg
TAK-831 750 mg, suspension, orally, once on Day 1.
OG006
Part 2: TAK-831 30 mg
TAK-831 30 mg, suspension, orally, once on Day 1 and Days 4-16.
OG007
Part 2: TAK-831 100 mg
TAK-831 100 mg, suspension, orally, once on Day 1 and Days 4-16.
OG008
Part 2: TAK-831 200 mg
TAK-831 200 mg, suspension, orally, once on Day 1 and Days 4-16.
OG009
Part 2: TAK-831 400 mg
TAK-831 400 mg, suspension, orally, once on Day 1 and Days 4-16.
OG010
Part 3: Placebo
TAK-831 placebo-matching suspension, orally, once daily on Days 1-14.
OG011
Part 3: TAK-831 400 mg
TAK-831 400 mg, suspension, orally, once daily from Days 1-14.
OG012
Part 4: TAK-831 100 mg Tablet Fasted
TAK-831 100 mg, tablet, orally, once in fasted state on Day 1 of either Period 1, 2 or 3.
OG013
Part 4: TAK-831 100 mg Tablet Fed
TAK-831 100 mg, tablet, orally, once in fed state on Day 1 of either Period 1, 2 or 3.
OG014
Part 4: TAK-831 100 mg Suspension Fasted
TAK-831 100 mg, suspension, orally, once in fasted state on Day 1 of either Period 1, 2 or 3.
Units
Counts
Participants
OG0006
OG0016
OG0026
OG003
Title
Denominators
Categories
Day 1
Title
Measurements
OG0000.250(0.23 to 0.50)
OG0010.260(0.25 to 0.33)
OG0020.435(0.23 to 1.50)
OG003
Secondary
Part 1, 2 and 4: AUCt: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-831
The PK set included all participants with at least 1 estimable PK parameter for TAK-831.
Posted
Mean
Standard Deviation
nanogram*hour per milliliter (ng*hr/mL)
Day 1 pre-dose and at multiple time points (up to 96 hours in Part 1 and up to 72 hours in Part 2 and 4) post-dose
ID
Title
Description
OG000
Part 1: TAK-831 10 mg
TAK-831 10 milligram (mg), suspension, orally, once on Day 1.
OG001
Part 1: TAK-831 30 mg
TAK-831 30 mg, suspension, orally, once on Day 1.
OG002
Part 1: TAK-831 100 mg
TAK-831 100 mg, suspension, orally, once on Day 1.
OG003
Part 1: TAK-831 250 mg
TAK-831 250 mg, suspension, orally, once on Day 1.
OG004
Part 1: TAK-831 500 mg
TAK-831 500 mg, suspension, orally, once on Day 1.
OG005
Part 1: TAK-831 750 mg
TAK-831 750 mg, suspension, orally, once on Day 1.
OG006
Part 2: TAK-831 30 mg
TAK-831 30 mg, suspension, orally, once on Day 1 and Days 4-16.
OG007
Part 2: TAK-831 100 mg
TAK-831 100 mg, suspension, orally, once on Day 1 and Days 4-16.
OG008
Part 2: TAK-831 200 mg
TAK-831 200 mg, suspension, orally, once on Day 1 and Days 4-16.
OG009
Part 2: TAK-831 400 mg
TAK-831 400 mg, suspension, orally, once on Day 1 and Days 4-16.
OG010
Part 4: TAK-831 100 mg Tablet Fasted
TAK-831 100 mg, tablet, orally, once in fasted state on Day 1 of either Period 1, 2 or 3.
OG011
Part 4: TAK-831 100 mg Tablet Fed
TAK-831 100 mg, tablet, orally, once in fed state on Day 1 of either Period 1, 2 or 3.
OG012
Part 4: TAK-831 100 mg Suspension Fasted
TAK-831 100 mg, suspension, orally, once in fasted state on Day 1 of either Period 1, 2 or 3.
Units
Counts
Participants
OG0006
OG0016
OG0026
OG003
Title
Denominators
Categories
Title
Measurements
OG00098.0± 17.02
OG001463.8± 80.13
OG0021186.8± 256.67
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
OG000
OG001
OG002
OG003
OG004
OG005
Dose proportionality was evaluated using the following power model: ln (PK Parameter) = a+b*ln (dose), where a and b are the intercept and slope of the line, respectively. Dose proportionality was declared when the 90 % CI of the slope lies entirely within the critical region (0.9483, 1.0517) for the dose range of 10 mg to 750 mg.
Slope
0.8720
2-Sided
90
0.8145
0.9296
Superiority or Other (legacy)
Secondary
Part 1, 2 and 4: AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-831
The PK set included all participants with at least 1 estimable PK parameter for TAK-831.
Posted
Mean
Standard Deviation
ng*hr/mL
Day 1 pre-dose and at multiple time points (up to 96 hours in Part 1 and up to 72 hours in Part 2 and 4) post-dose
ID
Title
Description
OG000
Part 1: TAK-831 10 mg
TAK-831 10 milligram (mg), suspension, orally, once on Day 1.
OG001
Part 1: TAK-831 30 mg
TAK-831 30 mg, suspension, orally, once on Day 1.
OG002
Part 1: TAK-831 100 mg
TAK-831 100 mg, suspension, orally, once on Day 1.
OG003
Part 1: TAK-831 250 mg
TAK-831 250 mg, suspension, orally, once on Day 1.
OG004
Part 1: TAK-831 500 mg
TAK-831 500 mg, suspension, orally, once on Day 1.
OG005
Part 1: TAK-831 750 mg
TAK-831 750 mg, suspension, orally, once on Day 1.
OG006
Part 2: TAK-831 30 mg
TAK-831 30 mg, suspension, orally, once on Day 1 and Days 4-16.
OG007
Part 2: TAK-831 100 mg
TAK-831 100 mg, suspension, orally, once on Day 1 and Days 4-16.
OG008
Part 2: TAK-831 200 mg
TAK-831 200 mg, suspension, orally, once on Day 1 and Days 4-16.
OG009
Part 2: TAK-831 400 mg
TAK-831 400 mg, suspension, orally, once on Day 1 and Days 4-16.
OG010
Part 4: TAK-831 100 mg Tablet Fasted
TAK-831 100 mg, tablet, orally, once in fasted state on Day 1 of either Period 1, 2 or 3.
OG011
Part 4: TAK-831 100 mg Tablet Fed
TAK-831 100 mg, tablet, orally, once in fed state on Day 1 of either Period 1, 2 or 3.
OG012
Part 4: TAK-831 100 mg Suspension Fasted
TAK-831 100 mg, suspension, orally, once in fasted state on Day 1 of either Period 1, 2 or 3.
Units
Counts
Participants
OG0006
OG0016
OG0026
OG003
Title
Denominators
Categories
Title
Measurements
OG000109.7± 22.02
OG001499.2± 92.57
OG0021271.4± 253.26
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
OG000
OG001
OG002
OG003
OG004
OG005
Dose proportionality was evaluated using the following power model: ln (PK Parameter) = a+b*ln (dose), where a and b are the intercept and slope of the line, respectively. Dose proportionality was declared when the 90 % CI of the slope lies entirely within the critical region (0.9483, 1.0517) for the dose range of 10 mg to 750 mg.
Power model
<0.001
Slope
0.8505
2-Sided
90
0.7925
0.9084
Superiority or Other (legacy)
Secondary
Part 2 and 3: AUCτ: Area Under the Plasma Concentration-time Curve From Time 0 to Time Tau Over the Dosing Interval for TAK-831
The PK set included all participants with at least 1 estimable PK parameter for TAK-831. Due to discomfort observed in participants from the CSF collection procedure, Part 3 of the study was terminated hence no participants were analyzed.
Posted
Mean
Standard Deviation
ng*hr/mL
Day 16 (Part 2) and Day 14 (Part 3) pre-dose and at multiple time points (up to 24 hours) post-dose
ID
Title
Description
OG000
Part 2: TAK-831 30 mg
TAK-831 30 mg, suspension, orally, once on Day 1 and Days 4-16.
OG001
Part 2: TAK-831 100 mg
TAK-831 100 mg, suspension, orally, once on Day 1 and Days 4-16.
OG002
Part 2: TAK-831 200 mg
TAK-831 200 mg, suspension, orally, once on Day 1 and Days 4-16.
OG003
Part 2: TAK-831 400 mg
TAK-831 400 mg, suspension, orally, once on Day 1 and Days 4-16.
OG004
Part 3: TAK-831 400 mg
TAK-831 400 mg, suspension, orally, once daily from Days 1-14.
Units
Counts
Participants
OG0006
OG0016
OG0026
OG003
Title
Denominators
Categories
Title
Measurements
OG000319.8± 83.06
OG0011211.0± 236.45
OG0021973.0± 316.34
OG003
0
12
6
12
EG001
Part 1: TAK-831 10 mg
TAK-831 10 milligram (mg), suspension, orally, once on Day 1.
0
6
2
6
EG002
Part 1: TAK-831 30 mg
TAK-831 30 mg, suspension, orally, once on Day 1.
0
6
2
6
EG003
Part 1: TAK-831 100 mg
TAK-831 100 mg, suspension, orally, once on Day 1.
0
6
2
6
EG004
Part 1: TAK-831 250 mg
TAK-831 250 mg, suspension, orally, once on Day 1.
0
6
1
6
EG005
Part 1: TAK-831 500 mg
TAK-831 500 mg, suspension, orally, once on Day 1.
0
6
3
6
EG006
Part 1: TAK-831 750 mg
TAK-831 750 mg, suspension, orally, once on Day 1.
0
6
4
6
EG007
Part 2: Placebo Pooled
TAK-831 placebo-matching suspension, orally, once on Day 1 and Days 4-16.
0
8
6
8
EG008
Part 2: TAK-831 30 mg
TAK-831 30 mg, suspension, orally, once on Day 1 and Days 4-16.
0
6
5
6
EG009
Part 2: TAK-831 100 mg
TAK-831 100 mg, suspension, orally, once on Day 1 and Days 4-16.
0
6
6
6
EG010
Part 2: TAK-831 200 mg
TAK-831 200 mg, suspension, orally, once on Day 1 and Days 4-16.
0
6
2
6
EG011
Part 2: TAK-831 400 mg
TAK-831 400 mg, suspension, orally, once on Day 1 and Days 4-16.
0
6
5
6
EG012
Part 3: Placebo
TAK-831 placebo-matching suspension, orally, once daily on Days 1-14.
0
1
1
1
EG013
Part 3: TAK-831 400 mg
TAK-831 400 mg, suspension, orally, once daily from Days 1-14.
0
5
5
5
EG014
Part 4: TAK-831 100 mg Tablet Fasted
TAK-831 100 mg, tablet, orally, once in fasted state on Day 1 of either Period 1, 2 or 3.
0
23
5
23
EG015
Part 4: TAK-831 100 mg Tablet Fed
TAK-831 100 mg, tablet, orally, once in fed state on Day 1 of either Period 1, 2 or 3.
0
23
3
23
EG016
Part 4: TAK-831 100 mg Suspension Fasted
TAK-831 100 mg, suspension, orally, once in fasted state on Day 1 of either Period 1, 2 or 3.
0
24
4
24
EG0000 events0 affected12 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0051 events1 affected6 at risk
EG0061 events1 affected6 at risk
EG0071 events1 affected8 at risk
EG0081 events1 affected6 at risk
EG0095 events3 affected6 at risk
EG0101 events1 affected6 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected1 at risk
EG0134 events3 affected5 at risk
EG0141 events1 affected23 at risk
EG0150 events0 affected23 at risk
EG0161 events1 affected24 at risk
Vomiting
Gastrointestinal disorders
MedDRA (19.0)
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0061 events1 affected6 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected6 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected1 at risk
EG0134 events2 affected5 at risk
EG0140 events0 affected23 at risk
EG0150 events0 affected23 at risk
EG0160 events0 affected24 at risk
Dry mouth
Gastrointestinal disorders
MedDRA (19.0)
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0051 events1 affected6 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected6 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected1 at risk
EG0130 events0 affected5 at risk
EG0140 events0 affected23 at risk
EG0150 events0 affected23 at risk
EG0160 events0 affected24 at risk
Dyspepsia
Gastrointestinal disorders
MedDRA (19.0)
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected6 at risk
EG0091 events1 affected6 at risk
EG0101 events1 affected6 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected1 at risk
EG0130 events0 affected5 at risk
EG0140 events0 affected23 at risk
EG0150 events0 affected23 at risk
EG0160 events0 affected24 at risk
Oral pain
Gastrointestinal disorders
MedDRA (19.0)
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0031 events1 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected6 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected1 at risk
EG0130 events0 affected5 at risk
EG0140 events0 affected23 at risk
EG0150 events0 affected23 at risk
EG0160 events0 affected24 at risk
Swollen tongue
Gastrointestinal disorders
MedDRA (19.0)
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0031 events1 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected6 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected1 at risk
EG0130 events0 affected5 at risk
EG0140 events0 affected23 at risk
EG0150 events0 affected23 at risk
EG0160 events0 affected24 at risk
Abdominal discomfort
Gastrointestinal disorders
MedDRA (19.0)
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected8 at risk
EG0082 events2 affected6 at risk
EG0090 events0 affected6 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected1 at risk
EG0130 events0 affected5 at risk
EG0140 events0 affected23 at risk
EG0150 events0 affected23 at risk
EG0160 events0 affected24 at risk
Abdominal pain
Gastrointestinal disorders
MedDRA (19.0)
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected6 at risk
EG0091 events1 affected6 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected1 at risk
EG0131 events1 affected5 at risk
EG0140 events0 affected23 at risk
EG0150 events0 affected23 at risk
EG0160 events0 affected24 at risk
Diarrhoea
Gastrointestinal disorders
MedDRA (19.0)
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected6 at risk
EG0101 events1 affected6 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected1 at risk
EG0130 events0 affected5 at risk
EG0144 events2 affected23 at risk
EG0150 events0 affected23 at risk
EG0160 events0 affected24 at risk
Eructation
Gastrointestinal disorders
MedDRA (19.0)
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected6 at risk
EG0100 events0 affected6 at risk
EG0111 events1 affected6 at risk
EG0120 events0 affected1 at risk
EG0130 events0 affected5 at risk
EG0140 events0 affected23 at risk
EG0150 events0 affected23 at risk
EG0160 events0 affected24 at risk
Abdominal distension
Gastrointestinal disorders
MedDRA (19.0)
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected6 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected1 at risk
EG0130 events0 affected5 at risk
EG0141 events1 affected23 at risk
EG0150 events0 affected23 at risk
EG0160 events0 affected24 at risk
Catheter site bruise
General disorders
MedDRA (19.0)
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0061 events1 affected6 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected6 at risk
EG0091 events1 affected6 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected1 at risk
EG0130 events0 affected5 at risk
EG0140 events0 affected23 at risk
EG0150 events0 affected23 at risk
EG0160 events0 affected24 at risk
Catheter site related reaction
General disorders
MedDRA (19.0)
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected6 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected1 at risk
EG0130 events0 affected5 at risk
EG0140 events0 affected23 at risk
EG0150 events0 affected23 at risk
EG0160 events0 affected24 at risk
Chills
General disorders
MedDRA (19.0)
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected6 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected1 at risk
EG0130 events0 affected5 at risk
EG0140 events0 affected23 at risk
EG0150 events0 affected23 at risk
EG0160 events0 affected24 at risk
Fatigue
General disorders
MedDRA (19.0)
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
EG0071 events1 affected8 at risk
EG0080 events0 affected6 at risk
EG0093 events2 affected6 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected1 at risk
EG0130 events0 affected5 at risk
EG0140 events0 affected23 at risk
EG0150 events0 affected23 at risk
EG0160 events0 affected24 at risk
Feeling cold
General disorders
MedDRA (19.0)
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected6 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected1 at risk
EG0130 events0 affected5 at risk
EG0140 events0 affected23 at risk
EG0150 events0 affected23 at risk
EG0160 events0 affected24 at risk
Feeling abnormal
General disorders
MedDRA (19.0)
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
EG0073 events1 affected8 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected6 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected1 at risk
EG0130 events0 affected5 at risk
EG0140 events0 affected23 at risk
EG0150 events0 affected23 at risk
EG0160 events0 affected24 at risk
Nasopharyngitis
Infections and infestations
MedDRA (19.0)
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected6 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected1 at risk
EG0131 events1 affected5 at risk
EG0140 events0 affected23 at risk
EG0150 events0 affected23 at risk
EG0160 events0 affected24 at risk
Influenza like illness
General disorders
MedDRA (19.0)
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected6 at risk
EG0100 events0 affected6 at risk
EG0111 events1 affected6 at risk
EG0120 events0 affected1 at risk
EG0130 events0 affected5 at risk
EG0140 events0 affected23 at risk
EG0150 events0 affected23 at risk
EG0160 events0 affected24 at risk
Fungal skin infection
Infections and infestations
MedDRA (19.0)
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected6 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected1 at risk
EG0130 events0 affected5 at risk
EG0140 events0 affected23 at risk
EG0151 events1 affected23 at risk
EG0160 events0 affected24 at risk
Ligament sprain
Injury, poisoning and procedural complications
MedDRA (19.0)
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected6 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected1 at risk
EG0130 events0 affected5 at risk
EG0140 events0 affected23 at risk
EG0150 events0 affected23 at risk
EG0160 events0 affected24 at risk
Nail injury
Injury, poisoning and procedural complications
MedDRA (19.0)
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected8 at risk
EG0081 events1 affected6 at risk
EG0090 events0 affected6 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected1 at risk
EG0130 events0 affected5 at risk
EG0140 events0 affected23 at risk
EG0150 events0 affected23 at risk
EG0160 events0 affected24 at risk
Headache
Nervous system disorders
MedDRA (19.0)
Systematic Assessment
EG0001 events1 affected12 at risk
EG0011 events1 affected6 at risk
EG0022 events1 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
EG0075 events2 affected8 at risk
EG0083 events2 affected6 at risk
EG0097 events4 affected6 at risk
EG0100 events0 affected6 at risk
EG0113 events2 affected6 at risk
EG0122 events1 affected1 at risk
EG01316 events5 affected5 at risk
EG0141 events1 affected23 at risk
EG0151 events1 affected23 at risk
EG0161 events1 affected24 at risk
Dizziness
Nervous system disorders
MedDRA (19.0)
Systematic Assessment
EG0002 events1 affected12 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0031 events1 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
EG0075 events1 affected8 at risk
EG0080 events0 affected6 at risk
EG0093 events2 affected6 at risk
EG0100 events0 affected6 at risk
EG0111 events1 affected6 at risk
EG0120 events0 affected1 at risk
EG0131 events1 affected5 at risk
EG0140 events0 affected23 at risk
EG0150 events0 affected23 at risk
EG0160 events0 affected24 at risk
Dizziness postural
Nervous system disorders
MedDRA (19.0)
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
EG0079 events3 affected8 at risk
EG0087 events3 affected6 at risk
EG00913 events4 affected6 at risk
EG0100 events0 affected6 at risk
EG0119 events3 affected6 at risk
EG0120 events0 affected1 at risk
EG0130 events0 affected5 at risk
EG0140 events0 affected23 at risk
EG0150 events0 affected23 at risk
EG0161 events1 affected24 at risk
Dysgeusia
Nervous system disorders
MedDRA (19.0)
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0061 events1 affected6 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected6 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected1 at risk
EG0130 events0 affected5 at risk
EG0140 events0 affected23 at risk
EG0150 events0 affected23 at risk
EG0160 events0 affected24 at risk
Presyncope
Nervous system disorders
MedDRA (19.0)
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
EG0071 events1 affected8 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected6 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected1 at risk
EG0130 events0 affected5 at risk
EG0140 events0 affected23 at risk
EG0150 events0 affected23 at risk
EG0160 events0 affected24 at risk
Somnolence
Nervous system disorders
MedDRA (19.0)
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
EG0071 events1 affected8 at risk
EG0080 events0 affected6 at risk
EG0093 events2 affected6 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected1 at risk
EG0130 events0 affected5 at risk
EG0140 events0 affected23 at risk
EG0151 events1 affected23 at risk
EG0160 events0 affected24 at risk
Paraesthesia
Nervous system disorders
MedDRA (19.0)
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
EG0073 events1 affected8 at risk
EG0080 events0 affected6 at risk
EG0091 events1 affected6 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected1 at risk
EG0132 events2 affected5 at risk
EG0140 events0 affected23 at risk
EG0150 events0 affected23 at risk
EG0160 events0 affected24 at risk
Tremor
Nervous system disorders
MedDRA (19.0)
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
EG0071 events1 affected8 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected6 at risk
EG0101 events1 affected6 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected1 at risk
EG0130 events0 affected5 at risk
EG0140 events0 affected23 at risk
EG0150 events0 affected23 at risk
EG0160 events0 affected24 at risk
Disturbance in attention
Nervous system disorders
MedDRA (19.0)
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected6 at risk
EG0091 events1 affected6 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected1 at risk
EG0130 events0 affected5 at risk
EG0140 events0 affected23 at risk
EG0150 events0 affected23 at risk
EG0160 events0 affected24 at risk
Lethargy
Nervous system disorders
MedDRA (19.0)
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected6 at risk
EG0091 events1 affected6 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected1 at risk
EG0130 events0 affected5 at risk
EG0140 events0 affected23 at risk
EG0150 events0 affected23 at risk
EG0160 events0 affected24 at risk
Memory impairment
Nervous system disorders
MedDRA (19.0)
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
EG0071 events1 affected8 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected6 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected1 at risk
EG0130 events0 affected5 at risk
EG0140 events0 affected23 at risk
EG0150 events0 affected23 at risk
EG0160 events0 affected24 at risk
Insomnia
Psychiatric disorders
MedDRA (19.0)
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0051 events1 affected6 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected6 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected1 at risk
EG0130 events0 affected5 at risk
EG0140 events0 affected23 at risk
EG0150 events0 affected23 at risk
EG0160 events0 affected24 at risk
Disorientation
Psychiatric disorders
MedDRA (19.0)
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected6 at risk
EG0091 events1 affected6 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected1 at risk
EG0130 events0 affected5 at risk
EG0140 events0 affected23 at risk
EG0150 events0 affected23 at risk
EG0160 events0 affected24 at risk
Tearfulness
Psychiatric disorders
MedDRA (19.0)
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
EG0071 events1 affected8 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected6 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected1 at risk
EG0130 events0 affected5 at risk
EG0140 events0 affected23 at risk
EG0150 events0 affected23 at risk
EG0160 events0 affected24 at risk
Throat irritation
Respiratory, thoracic and mediastinal disorders
MedDRA (19.0)
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0041 events1 affected6 at risk
EG0051 events1 affected6 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected6 at risk
EG0091 events1 affected6 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected1 at risk
EG0131 events1 affected5 at risk
EG0141 events1 affected23 at risk
EG0150 events0 affected23 at risk
EG0160 events0 affected24 at risk
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA (19.0)
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0061 events1 affected6 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected6 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected1 at risk
EG0130 events0 affected5 at risk
EG0140 events0 affected23 at risk
EG0150 events0 affected23 at risk
EG0160 events0 affected24 at risk
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA (19.0)
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0031 events1 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
EG0072 events1 affected8 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected6 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected1 at risk
EG0130 events0 affected5 at risk
EG0140 events0 affected23 at risk
EG0150 events0 affected23 at risk
EG0160 events0 affected24 at risk
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA (19.0)
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected6 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected1 at risk
EG0130 events0 affected5 at risk
EG0140 events0 affected23 at risk
EG0150 events0 affected23 at risk
EG0161 events1 affected24 at risk
Dermatitis contact
Skin and subcutaneous tissue disorders
MedDRA (19.0)
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0061 events1 affected6 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected6 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected1 at risk
EG0130 events0 affected5 at risk
EG0140 events0 affected23 at risk
EG0150 events0 affected23 at risk
EG0160 events0 affected24 at risk
Dry skin
Skin and subcutaneous tissue disorders
MedDRA (19.0)
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected6 at risk
EG0101 events1 affected6 at risk
EG0111 events1 affected6 at risk
EG0120 events0 affected1 at risk
EG0130 events0 affected5 at risk
EG0140 events0 affected23 at risk
EG0151 events1 affected23 at risk
EG0160 events0 affected24 at risk
Erythema
Skin and subcutaneous tissue disorders
MedDRA (19.0)
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
EG0071 events1 affected8 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected6 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected1 at risk
EG0130 events0 affected5 at risk
EG0140 events0 affected23 at risk
EG0150 events0 affected23 at risk
EG0160 events0 affected24 at risk
Palpitations
Cardiac disorders
MedDRA (19.0)
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected6 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected1 at risk
EG0130 events0 affected5 at risk
EG0140 events0 affected23 at risk
EG0150 events0 affected23 at risk
EG0161 events1 affected24 at risk
Eye irritation
Eye disorders
MedDRA (19.0)
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected6 at risk
EG0091 events1 affected6 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected1 at risk
EG0130 events0 affected5 at risk
EG0140 events0 affected23 at risk
EG0150 events0 affected23 at risk
EG0160 events0 affected24 at risk
Muscle twitching
Musculoskeletal and connective tissue disorders
MedDRA (19.0)
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected8 at risk
EG0082 events2 affected6 at risk
EG0090 events0 affected6 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected1 at risk
EG0130 events0 affected5 at risk
EG0140 events0 affected23 at risk
EG0150 events0 affected23 at risk
EG0160 events0 affected24 at risk
Musculoskeletal stiffness
Musculoskeletal and connective tissue disorders
MedDRA (19.0)
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected8 at risk
EG0081 events1 affected6 at risk
EG0090 events0 affected6 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected1 at risk
EG0131 events1 affected5 at risk
EG0140 events0 affected23 at risk
EG0150 events0 affected23 at risk
EG0160 events0 affected24 at risk
Flatulence
Gastrointestinal disorders
MedDRA (19.0)
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected6 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected1 at risk
EG0131 events1 affected5 at risk
EG0140 events0 affected23 at risk
EG0150 events0 affected23 at risk
EG0160 events0 affected24 at risk
Catheter site pain
General disorders
MedDRA (19.0)
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected6 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected1 at risk
EG0132 events2 affected5 at risk
EG0140 events0 affected23 at risk
EG0150 events0 affected23 at risk
EG0160 events0 affected24 at risk
Back pain
Musculoskeletal and connective tissue disorders
MedDRA (19.0)
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected6 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected1 at risk
EG0135 events4 affected5 at risk
EG0140 events0 affected23 at risk
EG0150 events0 affected23 at risk
EG0160 events0 affected24 at risk
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA (19.0)
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected6 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected6 at risk
EG0121 events1 affected1 at risk
EG0132 events1 affected5 at risk
EG0140 events0 affected23 at risk
EG0150 events0 affected23 at risk
EG0160 events0 affected24 at risk
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA (19.0)
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected6 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected1 at risk
EG0131 events1 affected5 at risk
EG0140 events0 affected23 at risk
EG0150 events0 affected23 at risk
EG0160 events0 affected24 at risk
Trismus
Musculoskeletal and connective tissue disorders
MedDRA (19.0)
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected6 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected1 at risk
EG0131 events1 affected5 at risk
EG0140 events0 affected23 at risk
EG0150 events0 affected23 at risk
EG0160 events0 affected24 at risk
Hypoaesthesia
Nervous system disorders
MedDRA (19.0)
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected6 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected1 at risk
EG0131 events1 affected5 at risk
EG0140 events0 affected23 at risk
EG0150 events0 affected23 at risk
EG0160 events0 affected24 at risk
Hyperhidrosis
Skin and subcutaneous tissue disorders
MedDRA (19.0)
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected6 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected1 at risk
EG0131 events1 affected5 at risk
EG0140 events0 affected23 at risk
EG0150 events0 affected23 at risk
EG0160 events0 affected24 at risk
Hypoacusis
Ear and labyrinth disorders
MedDRA (19.0)
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected6 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected6 at risk
EG0121 events1 affected1 at risk
EG0130 events0 affected5 at risk
EG0140 events0 affected23 at risk
EG0150 events0 affected23 at risk
EG0160 events0 affected24 at risk
Tinnitus
Ear and labyrinth disorders
MedDRA (19.0)
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected6 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected1 at risk
EG0131 events1 affected5 at risk
EG0140 events0 affected23 at risk
EG0150 events0 affected23 at risk
EG0160 events0 affected24 at risk
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Generally, the PI may publish results of the study following the publication of results by the Sponsor.
D002493
Central Nervous System Diseases
D009422
Nervous System Diseases
D001259
Ataxia
D020820
Dyskinesias
D009461
Neurologic Manifestations
D012816
Signs and Symptoms
D013568
Pathological Conditions, Signs and Symptoms
1
BG0050
BG0061
BG0071
BG0080
BG0090
BG0101
BG0110
BG0120
BG0131
BG0140
BG0151
BG0160
BG0179
0
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
BG0110
BG0120
BG0130
BG0140
BG0150
BG0160
BG0170
0
BG0050
BG0060
BG0071
BG0082
BG0091
BG0100
BG0110
BG0120
BG0130
BG0141
BG0150
BG0160
BG0177
5
BG0056
BG0065
BG0076
BG0084
BG0095
BG0105
BG0116
BG0121
BG0134
BG0146
BG0157
BG0168
BG01793
0
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
BG0110
BG0120
BG0130
BG0141
BG0150
BG0160
BG0171
0
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
BG0110
BG0120
BG0130
BG0140
BG0150
BG0160
BG0170
1
BG0043
BG0053
BG0060
BG0073
BG0081
BG0091
BG0102
BG0111
BG0120
BG0131
BG0140
BG0153
BG0162
BG01728
4
BG0045
BG0055
BG0062
BG0075
BG0082
BG0093
BG0106
BG0116
BG0120
BG0132
BG0146
BG0157
BG0167
BG01777
1
BG0041
BG0052
BG0060
BG0075
BG0083
BG0092
BG0102
BG0112
BG0120
BG0132
BG0140
BG0154
BG0164
BG01732
6
OG0046
OG0056
OG0066
OG0078
OG0086
OG0096
OG0106
OG0116
OG0121
OG0135
OG01423
OG01523
OG01624
0
OG0040
OG0050
OG00616.7
OG0070
OG0080
OG00933.3
OG0100
OG0110
OG0120
OG0130
OG0140
OG0150
OG0160
6
OG0046
OG0056
OG0066
OG0078
OG0086
OG0096
OG0106
OG0116
OG0121
OG0135
OG01423
OG01523
OG01624
16.7
OG0040
OG00533.3
OG00616.7
OG00787.5
OG00866.7
OG00983.3
OG01033.3
OG01183.3
OG012100.0
OG01360.0
OG01413.0
OG01517.4
OG01629.2
> greater criteria
Title
Measurements
OG0008.3
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG00916.7
OG0100
OG01133.3
OG0120
OG01320.0
OG0144.3
OG0158.7
OG01612.5
6
OG0046
OG0056
OG0066
OG0078
OG0086
OG0096
OG0106
OG0116
OG0121
OG0135
OG01423
OG01523
OG01624
50.0
OG00416.7
OG00533.3
OG00616.7
OG00737.5
OG00833.3
OG00950.0
OG0100
OG01116.7
OG0120
OG01320.0
OG01413.0
OG01521.7
OG01616.7
> upper cut-off point criteria
Title
Measurements
OG0008.3
OG00150.0
OG0020
OG00316.7
OG0040
OG00533.3
OG00616.7
OG00725.0
OG00850.0
OG00916.7
OG01016.7
OG01116.7
OG0120
OG0130
OG0148.7
OG01513.0
OG01612.5
6
OG0046
OG0056
OG0066
OG0076
OG0086
OG0096
OG01023
OG01123
OG01224
905.8
± 329.53
OG0041304.5± 402.89
OG0052121.7± 554.92
OG006167.1± 39.95
OG007467.2± 84.36
OG0081087.3± 398.76
OG0091095.5± 236.86
OG010216.0± 104.68
OG011377.7± 175.90
OG012594.1± 288.77
OG006
OG007
OG008
OG009
Dose proportionality was evaluated using the following power model: ln (PK Parameter) = a+b*ln (dose), where a and b were the intercept and slope of the line, respectively. Dose proportionality was declared when the 90% CI of the slope lies entirely within the critical region (0.9139, 1.0861) for the dose range of 30 mg to 400 mg.
Power model
Slope
0.7795
2-Sided
90
0.6597
0.8993
Superiority or Other (legacy)
OG010
OG012
The point estimate and CI were obtained by taking the antilog of the difference in the log transformed lease square (LS) Means.
Least Square (LS) Mean Ratio
0.362
2-Sided
90
0.3043
0.4301
Superiority or Other (legacy)
OG010
OG011
The point estimate and CI were obtained by taking the antilog of the difference in the log transformed LS Means.
LS Mean Ratio
1.799
2-Sided
90
1.4625
2.2116
Superiority or Other (legacy)
6
OG0040
1269.5
± 451.37
6
OG0046
OG0056
OG0066
OG0076
OG0086
OG0096
OG0100
OG0110
OG01223
OG01323
OG01424
0.275
(0.23 to 2.02)
OG0040.725(0.20 to 1.00)
OG0050.760(0.25 to 2.02)
OG0060.500(0.47 to 0.68)
OG0070.500(0.17 to 2.00)
OG0080.375(0.17 to 1.02)
OG0090.500(0.15 to 1.00)
OG0120.930(0.25 to 4.00)
OG0133.980(0.95 to 4.05)
OG0140.250(0.17 to 2.02)
Day 16
Title
Measurements
OG000NA(NA to NA)Tmax for Part 1 was not planned to analyzed on Day 16.
OG001NA(NA to NA)Tmax for Part 1 was not planned to analyzed on Day 16.
OG002NA(NA to NA)Tmax for Part 1 was not planned to analyzed on Day 16.
OG003NA(NA to NA)Tmax for Part 1 was not planned to analyzed on Day 16.
OG004NA(NA to NA)Tmax for Part 1 was not planned to analyzed on Day 16.
OG005NA(NA to NA)Tmax for Part 1 was not planned to analyzed on Day 16.
OG0060.500(0.48 to 0.53)
OG0070.365(0.23 to 0.98)
OG0080.500(0.20 to 0.50)
OG0090.490(0.23 to 1.00)
OG012NA(NA to NA)Tmax for Part 4 was not planned to analyzed on Day 16.
OG013NA(NA to NA)Tmax for Part 4 was not planned to analyzed on Day 16.
OG014NA(NA to NA)Tmax for Part 4 was not planned to analyzed on Day 16.
6
OG0046
OG0056
OG0066
OG0076
OG0086
OG0096
OG01023
OG01123
OG01224
1900.8
± 293.72
OG0044111.1± 1599.18
OG0055374.0± 1651.36
OG006296.3± 95.31
OG007938.4± 180.29
OG0082030.2± 265.73
OG0092832.7± 819.36
OG010598.6± 310.31
OG0111397.7± 434.45
OG0121083.6± 302.13
OG006
OG007
OG008
OG009
Dose proportionality was evaluated using the following power model: ln (PK Parameter) = a+b*ln (dose), where a and b were the intercept and slope of the line, respectively. Dose proportionality was declared when the 90% CI of the slope lies entirely within the critical region (0.9139, 1.0861) for the dose range of 30 mg to 400 mg.
Power model
Slope
0.9135
2-Sided
90
0.8062
1.0209
Superiority or Other (legacy)
OG010
OG012
The point estimate and CI were obtained by taking the antilog of the difference in the log transformed LS Means.
LS Mean Ratio
0.500
2-Sided
90
0.4324
0.5777
Superiority or Other (legacy)
OG010
OG011
The point estimate and CI were obtained by taking the antilog of the difference in the log transformed LS Means.
LS Mean Ratio
2.563
2-Sided
90
2.1000
3.1275
Superiority or Other (legacy)
6
OG0046
OG0056
OG0066
OG0076
OG0086
OG0096
OG01023
OG01123
OG01224
1945.5
± 294.36
OG0044140.7± 1602.32
OG0055512.0± 1721.84
OG006342.9± 46.80
OG007980.5± 204.04
OG0082092.7± 273.06
OG0092866.6± 822.22
OG010653.7± 308.86
OG0111428.8± 433.24
OG0121115.3± 296.56
OG006
OG007
OG008
OG009
Dose proportionality was evaluated using the following power model: ln (PK Parameter) = a+b*ln (dose), where a and b were the intercept and slope of the line, respectively. Dose proportionality was declared when the 90% CI of the slope lies entirely within the critical region (0.9139, 1.0861) for the dose range of 30 mg to 400 mg.
Power model
<0.001
Slope
0.8415
2-Sided
90
0.7618
0.9212
Superiority or Other (legacy)
OG010
OG012
The point estimate and CI were obtained by taking the antilog of the difference in the log transformed LS Means.
LS Mean Ratio
0.543
2-Sided
90
0.4797
0.6149
Superiority or Other (legacy)
OG010
OG011
The point estimate and CI were obtained by taking the antilog of the difference in the log transformed LS Means.