4-Week, Multiple-dose, Dose-escalating Study In Patients... | NCT03538743 | Trialant
NCT03538743
Sponsor
Pfizer
Status
Completed
Last Update Posted
Jul 1, 2020Actual
Enrollment
98Actual
Phase
Phase 1
Conditions
Type 2 Diabetes Mellitus
Interventions
Placebo
PF-06882961
PF-06882961
PF-06882961
PF-06882961
PF-06882961
PF-06882961
PF-06882961
PF-06882961
Countries
United States
Protocol Section
Identification Module
NCT ID
Results Section
Participant Flow Module
Pre-assignment Details
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Derived Section
Miscellaneous Info Module
Version Holder
NCT03538743
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
C3421002
Secondary IDs
Not provided
Brief Title
4-Week, Multiple-dose, Dose-escalating Study In Patients With Type 2 Diabetes
Official Title
A PHASE 1, RANDOMIZED, DOUBLE-BLIND, SPONSOR-OPEN, PLACEBO-CONTROLLED STUDY TO ASSESS THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF MULTIPLE ESCALATING ORAL DOSES OF PF-06882961 IN ADULT SUBJECTS WITH TYPE 2 DIABETES MELLITUS
Acronym
Not provided
Organization
PfizerINDUSTRY
Status Module
Record Verification Date
Jun 2020
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Jun 25, 2018Actual
Primary Completion Date
May 23, 2019Actual
Completion Date
Jun 10, 2019Actual
First Submitted Date
May 7, 2018
First Submission Date that Met QC Criteria
May 24, 2018
First Posted Date
May 29, 2018Actual
Results Waived
Not provided
Results First Submitted Date
May 8, 2020
Results First Submitted that Met QC Criteria
Jun 17, 2020
Results First Posted Date
Jul 1, 2020Actual
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 17, 2020
Last Update Posted Date
Jul 1, 2020Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
PfizerINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
This is a dose-escalating study in patients with Type 2 diabetes on metformin. Participants will receive an investigational product or placebo for 28 days.
Detailed Description
Not provided
Conditions Module
Conditions
Type 2 Diabetes Mellitus
Keywords
Type 2 diabetes mellitus
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
98Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Placebo
Placebo Comparator
Drug: Placebo
PF-06882961 30 mg
Experimental
Drug: PF-06882961
PF-06882961 100 mg
Experimental
Drug: PF-06882961
PF-06882961 300 mg
Experimental
Drug: PF-06882961
PF-06882961 600 mg
Experimental
Drug: PF-06882961
PF-06882961 dose TBD Cohort 5
Experimental
Drug: PF-06882961
PF-06882961 dose TBD Cohort 6
Experimental
Drug: PF-06882961
PF-06882961 dose TBD Cohort 7
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Placebo
Drug
Tablet, 0 mg, twice daily, 28 days
Placebo
PF-06882961
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number of Participants With All-causality and Treatment-related Treatment-emergent Adverse Events (TEAEs)
Treatment-related adverse event (AE) was any untoward medical occurrence attributed to study treatment in a participant who received study treatment. A serious AE (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening; initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect. Any such events with initial onset or increasing in severity after the first dose of study treatment were counted as treatment-emergent.
From baseline to up to 35 days after last dose for a total of approximately 63 days
Number of Participants With Laboratory Abnormalities Without Regard to Baseline Abnormality
From baseline to up to 14 days after last dose for a total of approximately 42 days
Number of Participants With Abnormal Vital Signs
Vital signs categorical summarization criteria: 1) supine systolic blood pressure (SBP) <90 millimeters of mercury (mmHg); 2) supine diastolic blood pressure (DBP) <50 mmHg; 3) supine pulse rate <40 or >120 beats per minute (bpm); 4) change from baseline (increase or decrease) in supine SBP greater than or equal to (>=) 30 mmHg; 5) change from baseline (increase or decrease) in supine DBP >= 20 mmHg.
From baseline to up to 14 days after last dose for a total of approximately 42 days
Secondary Outcomes
Measure
Description
Time Frame
AUC24 and AUCtau of PF-06882961 on Day 1, Day 14 or 21 and Day 28
Area under the concentration-time profile from time zero to time 24 hours (AUC24) was calculated as AUCtau1 +AUCtau2, where AUCtau was area under the plasma concentration-time profile from time zero to time tau (tau1 = 0 to 10 hours and tau2=10 to 24 hours). AUCtau was determined using linear/log trapezoidal method.
0, 1, 2, 4, 6, 8, 10, 12, 14 and 24 hrs post dose on Day 1, 14 or 21, and 28
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Type 2 diabetes treated with a stable dose of metformin at least 500 mg
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
Types
Not provided
Time Frame
Not provided
Access Criteria
Not provided
URL
Not provided
Not provided
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Placebo
Placebo matched to PF-06882961 was administered orally once daily (QD) or twice daily (BID) (dependent upon corresponding study treatment regimen) for a total of 28 days.
FG001
PF-06882961 10mg BID
PF-06882961 tablet was administered orally at 5 mg BID from Day 1 to Day 14 followed by a dose of 10 mg BID from Day 15 to Day 28.
FG002
PF-06882961 15mg BID
PF-06882961 tablet was administered orally at 15 mg BID for a total of 28 days.
FG003
PF-06882961 50mg BID
PF-06882961 tablet was administered orally at 50 mg BID for a total of 28 days.
FG004
PF-06882961 70mg BID
PF-06882961 tablet was administered orally at 20 mg (Day 1-3), 40 mg (Day 4-6), 50 mg (Day 7-9) and 70 mg (Day 10-28) BID for a total of 28 days.
FG005
PF-06882961 120mg BID
PF-06882961 tablet was administered orally at 20 mg (Day 1-2), 40 mg (Day 3-4), 60 mg (Day 5-6), 80 mg (Day 7-9), 100 mg (Day 10-12) and 120 mg (Day 13-28) BID for a total of 28 days.
FG006
PF-06882961 120mg BID Slow Titration (ST)
PF-06882961 tablet was administered orally at 10 mg (Day 1-4), 20 mg (Day 5-8), 40 mg (Day 9-12), 60 mg (Day 13-16), 80 mg (Day 17-20), 100 mg (Day 21-24) and 120 mg (Day 25-28) BID for a total of 28 days.
FG007
PF-06882961 120mg QD
PF-06882961 tablet was administered orally at 10 mg (Day 1-2), 20 mg (Day 3-4), 30 mg (Day 5-6), 40 mg (Day 7-10), 60 mg (Day 11-14), 80 mg (Day 15-18), 100 mg (Day 19-22) and 120 mg (Day 23-28) QD for a total of 28 days.
FG008
PF-06882961 200mg QD Controlled Release (CR)
PF-06882961 CR tablet was administered orally at 50 mg (Day 1-7), 100 mg (Day 8-14), 150 mg (Day 15-21) and 200 mg (Day 22-28) QD for a total of 28 days.
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
FG00025 subjects
FG0019 subjects
FG0029 subjects
FG00310 subjects
FG0049 subjects
FG0059 subjects
FG0069 subjects
FG0078 subjects
FG00810 subjects
Received Treatment
FG00025 subjects
FG0019 subjects
FG0029 subjects
FG00310 subjects
FG004
COMPLETED
FG00025 subjects
FG0019 subjects
FG0028 subjects
FG0038 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0032 subjects
FG004
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG003
Baseline Characteristics Module
Baseline Analysis Population Description
All randomized participants who received at least 1 dose of randomized study treatment.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Placebo
Placebo matched to PF-06882961 was administered orally QD or BID(dependent upon corresponding study treatment regimen) for a total of 28 days.
BG001
PF-06882961 10mg BID
Denominators
Units
Counts
Participants
BG000
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Customized
Count of Participants
Outcome Measures Module
Outcome Measures
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Number of Participants With All-causality and Treatment-related Treatment-emergent Adverse Events (TEAEs)
Treatment-related adverse event (AE) was any untoward medical occurrence attributed to study treatment in a participant who received study treatment. A serious AE (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening; initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect. Any such events with initial onset or increasing in severity after the first dose of study treatment were counted as treatment-emergent.
All randomized participants who received at least 1 dose of randomized study treatment.
Posted
Count of Participants
Participants
From baseline to up to 35 days after last dose for a total of approximately 63 days
ID
Title
Description
OG000
Placebo
Adverse Events Module
Frequency Threshold
5
Time Frame
Baseline up to 35 days after last dose for a total of approximately 63 days
Description
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
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
Placebo
Placebo matched to PF-06882961 was administered orally QD or BID(dependent upon corresponding study treatment regimen) for a total of 28 days.
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Acute myocardial infarction
Cardiac disorders
MedDRA v22.0
Non-systematic Assessment
This event occurred in the follow up period and was assessed as not treatment-related.
Number of Participants With Abnormal Electrocardiogram (ECG) Interval
ECG categorical summarization criteria: 1. PR interval (the interval between the start of the P wave and the start of the QRS complex, corresponding to the time between the onset of the atrial depolarization and onset of ventricular depolarization): a) greater than or equal to (>=) 300 millisecond (msec), b) >=25% increase when baseline is > 200 msec or >=50% increase when baseline is less than or equal to (<=) 200 msec.
2. QRS duration (time from ECG Q wave to the end of the S wave corresponding to ventricle depolarization): a) >=140 msec, b) >=50% increase from baseline.
3. QTcF interval (QT corrected using the Fridericia formula): a) >450 msec and <=480 msec, b) >480 msec and <=500 msec, c) >500 msec, d) >30 msec and <=60 msec increase from baseline, e) >60 msec increase from baseline
From baseline to up to 14 days after last dose for a total of approximately 42 days
Maximum Plasma Concentration (Cmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28
For BID dosing, parameters were calculated for both dosing intervals (0-10 hr = interval 1 and 10-24 hr = interval 2) and were displayed as Cmax1, Cmax2.
Cmax1: maximum plasma concentration during the dosing interval τ1 =0 to 10 hours.
Cmax2: maximum plasma concentration during the dosing interval τ2=10 to 24 hours.
0, 1, 2, 4, 6, 8, 10, 12, 14 and 24 hours post dose on Day 1, 14 or 21, and 28
Time for Cmax (Tmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28
Time for Cmax, Cmax1 and Cmax2 (Tmax, Tmax1 and Tmax2) of PF-06293620 was observed directly from data as time of first occurrence.
0, 1, 2, 4, 6, 8, 10, 12, 14 and 24 hrs post dose on Day 1, 14 or 21, and 28
Terminal Half-life (t½) of PF-06882961 on Day 28
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
0, 1, 2, 4, 6, 8, 10, 12, 14 and 24 hrs post dose on Day 28
Amount of Unchanged Drug Recovered in Urine Over 24 Hours (Ae24) of PF-06882961 on Day 28
Ae was the cumulative amount of drug recovered unchanged in urine during the dosing interval, where the dosing interval was 24 hours. Cumulative amount was calculated as sum of urine drug concentration in sample volume for each collection interval. Sample volume = (urine weight in gram [g]/1.020), where 1.020 g/mL was the approximate specific gravity of urine.
0 to 24 hours post-dose on Day 28
Ae24 (%) of PF-06882961 on Day 28
Percent of dose recovered in urine as unchanged drug. Ae24% = 100* Ae24/Dose
0 to 24 hours post-dose on Day 28
Renal Clearance (CLr) of PF-06882961 on Day 28
CLr was calculated as Ae divided by AUCtau, where dosing interval is 24 hours.
0 to 24 hours post-dose on Day 28
South Miami
Florida
33143
United States
Qps-Mra,Llc
South Miami
Florida
33143
United States
Altasciences Clinical Kansas, Inc.
Overland Park
Kansas
66212
United States
9 subjects
FG0059 subjects
FG0069 subjects
FG0078 subjects
FG00810 subjects
9 subjects
FG0059 subjects
FG0069 subjects
FG0078 subjects
FG0087 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0083 subjects
1 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
Non-Treatment-Related Reasons
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0083 subjects
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
PF-06882961 tablet was administered orally at 5 mg BID from Day 1 to Day 14 followed by a dose of 10 mg BID from Day 15 to Day 28.
BG002
PF-06882961 15mg BID
PF-06882961 tablet was administered orally at 15 mg BID for a total of 28 days.
BG003
PF-06882961 50mg BID
PF-06882961 tablet was administered orally at 50 mg BID for a total of 28 days.
BG004
PF-06882961 70mg BID
PF-06882961 tablet was administered orally at 20 mg (Day 1-3), 40 mg (Day 4-6), 50 mg (Day 7-9) and 70 mg (Day 10-28) BID for a total of 28 days.
BG005
PF-06882961 120mg BID
PF-06882961 tablet was administered orally at 20 mg (Day 1-2), 40 mg (Day 3-4), 60 mg (Day 5-6), 80 mg (Day 7-9), 100 mg (Day 10-12) and 120 mg (Day 13-28) BID for a total of 28 days.
BG006
PF-06882961 120mg BID ST
PF-06882961 tablet was administered orally at 10 mg (Day 1-4), 20 mg (Day 5-8), 40 mg (Day 9-12), 60 mg (Day 13-16), 80 mg (Day 17-20), 100 mg (Day 21-24) and 120 mg (Day 25-28) BID for a total of 28 days.
BG007
PF-06882961 120mg QD
PF-06882961 tablet was administered orally at 10 mg (Day 1-2), 20 mg (Day 3-4), 30 mg (Day 5-6), 40 mg (Day 7-10), 60 mg (Day 11-14), 80 mg (Day 15-18), 100 mg (Day 19-22) and 120 mg (Day 23-28) QD for a total of 28 days.
BG008
PF-06882961 200mg QD CR
PF-06882961 CR tablet was administered orally at 50 mg (Day 1-7), 100 mg (Day 8-14), 150 mg (Day 15-21) and 200 mg (Day 22-28) QD for a total of 28 days.
BG009
Total
Total of all reporting groups
25
BG0019
BG0029
BG00310
BG0049
BG0059
BG0069
BG0078
BG00810
BG00998
Participants
Title
Denominators
Categories
Title
Measurements
18-44 years
BG0001
BG0011
BG0021
BG0030
BG0040
BG0051
BG0060
BG0070
BG0080
BG0094
45-64 years
BG00019
BG0018
BG0026
BG0036
BG004
>=65 years
BG0005
BG0010
BG0022
BG0034
BG004
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00013
BG0012
BG0026
BG0035
BG0045
BG0052
BG0065
BG0074
BG0085
BG00947
Male
BG00012
BG0017
BG0023
BG0035
BG004
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG00018
BG0016
BG0024
BG0037
BG0046
BG0054
BG0064
BG0076
BG0086
BG00961
Not Hispanic or Latino
BG0007
BG0013
BG0025
BG0033
BG004
Unknown or Not Reported
BG0000
BG0010
BG0020
BG0030
BG004
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
White
BG00018
BG0017
BG0025
BG0038
BG0047
BG0056
BG0064
BG0078
BG0087
BG00970
Black or African American
BG0007
BG0012
BG0023
BG0032
BG004
Native Hawaiian or Other Pacific Islander
BG0000
BG0010
BG0021
BG0030
BG004
Age Range
Median
Full Range
Years
Title
Denominators
Categories
Title
Measurements
BG00060.0(41 to 70)
BG00155.0(44 to 61)
BG00255.0(37 to 68)
BG00363.5(48 to 68)
BG00460.0(46 to 65)
BG00557.0(40 to 64)
BG00658.0(50 to 69)
BG00758.0(53 to 66)
BG00859.0(45 to 69)
BG00958.0(37 to 70)
Placebo matched to PF-06882961 was administered orally QD or BID(dependent upon corresponding study treatment regimen) for a total of 28 days.
OG001
PF-06882961 10mg BID
PF-06882961 tablet was administered orally at 5 mg BID from Day 1 to Day 14 followed by a dose of 10 mg BID from Day 15 to Day 28.
OG002
PF-06882961 15mg BID
PF-06882961 tablet was administered orally at 15 mg BID for a total of 28 days.
OG003
PF-06882961 50mg BID
PF-06882961 tablet was administered orally at 50 mg BID for a total of 28 days.
OG004
PF-06882961 70mg BID
PF-06882961 tablet was administered orally at 20 mg (Day 1-3), 40 mg (Day 4-6), 50 mg (Day 7-9) and 70 mg (Day 10-28) BID for a total of 28 days.
OG005
PF-06882961 120mg BID
PF-06882961 tablet was administered orally at 20 mg (Day 1-2), 40 mg (Day 3-4), 60 mg (Day 5-6), 80 mg (Day 7-9), 100 mg (Day 10-12) and 120 mg (Day 13-28) BID for a total of 28 days.
OG006
PF-06882961 120mg BID ST
PF-06882961 tablet was administered orally at 10 mg (Day 1-4), 20 mg (Day 5-8), 40 mg (Day 9-12), 60 mg (Day 13-16), 80 mg (Day 17-20), 100 mg (Day 21-24) and 120 mg (Day 25-28) BID for a total of 28 days.
OG007
PF-06882961 120mg QD
PF-06882961 tablet was administered orally at 10 mg (Day 1-2), 20 mg (Day 3-4), 30 mg (Day 5-6), 40 mg (Day 7-10), 60 mg (Day 11-14), 80 mg (Day 15-18), 100 mg (Day 19-22) and 120 mg (Day 23-28) QD for a total of 28 days.
OG008
PF-06882961 200mg QD CR
PF-06882961 CR tablet was administered orally at 50 mg (Day 1-7), 100 mg (Day 8-14), 150 mg (Day 15-21) and 200 mg (Day 22-28) QD for a total of 28 days.
Units
Counts
Participants
OG00025
OG0019
OG0029
OG00310
OG0049
OG0059
OG0069
OG0078
OG00810
Title
Denominators
Categories
All-causality AE
Title
Measurements
OG00017
OG0016
OG0028
OG00310
OG0048
OG0058
OG0069
OG0078
OG0089
All-causality SAE
Title
Measurements
OG0000
OG0010
OG0020
OG003
Treatment-related AE
Title
Measurements
OG00014
OG0014
OG0024
OG003
Treatment-related SAE
Title
Measurements
OG0000
OG0010
OG0020
OG003
Primary
Number of Participants With Laboratory Abnormalities Without Regard to Baseline Abnormality
All randomized participants who received at least 1 dose of randomized study treatment.
Posted
Count of Participants
Participants
From baseline to up to 14 days after last dose for a total of approximately 42 days
ID
Title
Description
OG000
Placebo
Placebo matched to PF-06882961 was administered orally QD or BID(dependent upon corresponding study treatment regimen) for a total of 28 days.
OG001
PF-06882961 10mg BID
PF-06882961 tablet was administered orally at 5 mg BID from Day 1 to Day 14 followed by a dose of 10 mg BID from Day 15 to Day 28.
OG002
PF-06882961 15mg BID
PF-06882961 tablet was administered orally at 15 mg BID for a total of 28 days.
OG003
PF-06882961 50mg BID
PF-06882961 tablet was administered orally at 50 mg BID for a total of 28 days.
OG004
PF-06882961 70mg BID
PF-06882961 tablet was administered orally at 20 mg (Day 1-3), 40 mg (Day 4-6), 50 mg (Day 7-9) and 70 mg (Day 10-28) BID for a total of 28 days.
OG005
PF-06882961 120mg BID
PF-06882961 tablet was administered orally at 20 mg (Day 1-2), 40 mg (Day 3-4), 60 mg (Day 5-6), 80 mg (Day 7-9), 100 mg (Day 10-12) and 120 mg (Day 13-28) BID for a total of 28 days.
OG006
PF-06882961 120mg BID ST
PF-06882961 tablet was administered orally at 10 mg (Day 1-4), 20 mg (Day 5-8), 40 mg (Day 9-12), 60 mg (Day 13-16), 80 mg (Day 17-20), 100 mg (Day 21-24) and 120 mg (Day 25-28) BID for a total of 28 days.
OG007
PF-06882961 120mg QD
PF-06882961 tablet was administered orally at 10 mg (Day 1-2), 20 mg (Day 3-4), 30 mg (Day 5-6), 40 mg (Day 7-10), 60 mg (Day 11-14), 80 mg (Day 15-18), 100 mg (Day 19-22) and 120 mg (Day 23-28) QD for a total of 28 days.
OG008
PF-06882961 200mg QD CR
PF-06882961 CR tablet was administered orally at 50 mg (Day 1-7), 100 mg (Day 8-14), 150 mg (Day 15-21) and 200 mg (Day 22-28) QD for a total of 28 days.
Units
Counts
Participants
OG00025
OG0019
OG0029
OG003
Title
Denominators
Categories
Title
Measurements
OG00024
OG0017
OG0028
OG003
Primary
Number of Participants With Abnormal Vital Signs
Vital signs categorical summarization criteria: 1) supine systolic blood pressure (SBP) <90 millimeters of mercury (mmHg); 2) supine diastolic blood pressure (DBP) <50 mmHg; 3) supine pulse rate <40 or >120 beats per minute (bpm); 4) change from baseline (increase or decrease) in supine SBP greater than or equal to (>=) 30 mmHg; 5) change from baseline (increase or decrease) in supine DBP >= 20 mmHg.
All randomized participants who received at least 1 dose of randomized study treatment.
Posted
Count of Participants
Participants
From baseline to up to 14 days after last dose for a total of approximately 42 days
ID
Title
Description
OG000
Placebo
Placebo matched to PF-06882961 was administered orally QD or BID(dependent upon corresponding study treatment regimen) for a total of 28 days.
OG001
PF-06882961 10mg BID
PF-06882961 tablet was administered orally at 5 mg BID from Day 1 to Day 14 followed by a dose of 10 mg BID from Day 15 to Day 28.
OG002
PF-06882961 15mg BID
PF-06882961 tablet was administered orally at 15 mg BID for a total of 28 days.
OG003
PF-06882961 50mg BID
PF-06882961 tablet was administered orally at 50 mg BID for a total of 28 days.
OG004
PF-06882961 70mg BID
PF-06882961 tablet was administered orally at 20 mg (Day 1-3), 40 mg (Day 4-6), 50 mg (Day 7-9) and 70 mg (Day 10-28) BID for a total of 28 days.
OG005
PF-06882961 120mg BID
PF-06882961 tablet was administered orally at 20 mg (Day 1-2), 40 mg (Day 3-4), 60 mg (Day 5-6), 80 mg (Day 7-9), 100 mg (Day 10-12) and 120 mg (Day 13-28) BID for a total of 28 days.
OG006
PF-06882961 120mg BID ST
PF-06882961 tablet was administered orally at 10 mg (Day 1-4), 20 mg (Day 5-8), 40 mg (Day 9-12), 60 mg (Day 13-16), 80 mg (Day 17-20), 100 mg (Day 21-24) and 120 mg (Day 25-28) BID for a total of 28 days.
OG007
PF-06882961 120mg QD
PF-06882961 tablet was administered orally at 10 mg (Day 1-2), 20 mg (Day 3-4), 30 mg (Day 5-6), 40 mg (Day 7-10), 60 mg (Day 11-14), 80 mg (Day 15-18), 100 mg (Day 19-22) and 120 mg (Day 23-28) QD for a total of 28 days.
OG008
PF-06882961 200mg QD CR
PF-06882961 CR tablet was administered orally at 50 mg (Day 1-7), 100 mg (Day 8-14), 150 mg (Day 15-21) and 200 mg (Day 22-28) QD for a total of 28 days.
Units
Counts
Participants
OG00025
OG0019
OG0029
OG003
Title
Denominators
Categories
Supine SBP <90 mmHg
Title
Measurements
OG0003
OG0013
OG0022
OG003
Primary
Number of Participants With Abnormal Electrocardiogram (ECG) Interval
ECG categorical summarization criteria: 1. PR interval (the interval between the start of the P wave and the start of the QRS complex, corresponding to the time between the onset of the atrial depolarization and onset of ventricular depolarization): a) greater than or equal to (>=) 300 millisecond (msec), b) >=25% increase when baseline is > 200 msec or >=50% increase when baseline is less than or equal to (<=) 200 msec.
2. QRS duration (time from ECG Q wave to the end of the S wave corresponding to ventricle depolarization): a) >=140 msec, b) >=50% increase from baseline.
3. QTcF interval (QT corrected using the Fridericia formula): a) >450 msec and <=480 msec, b) >480 msec and <=500 msec, c) >500 msec, d) >30 msec and <=60 msec increase from baseline, e) >60 msec increase from baseline
All randomized participants who received at least 1 dose of randomized study treatment.
Posted
Count of Participants
Participants
From baseline to up to 14 days after last dose for a total of approximately 42 days
ID
Title
Description
OG000
Placebo
Placebo matched to PF-06882961 was administered orally QD or BID(dependent upon corresponding study treatment regimen) for a total of 28 days.
OG001
PF-06882961 10mg BID
PF-06882961 tablet was administered orally at 5 mg BID from Day 1 to Day 14 followed by a dose of 10 mg BID from Day 15 to Day 28.
OG002
PF-06882961 15mg BID
PF-06882961 tablet was administered orally at 15 mg BID for a total of 28 days.
OG003
PF-06882961 50mg BID
PF-06882961 tablet was administered orally at 50 mg BID for a total of 28 days.
OG004
PF-06882961 70mg BID
PF-06882961 tablet was administered orally at 20 mg (Day 1-3), 40 mg (Day 4-6), 50 mg (Day 7-9) and 70 mg (Day 10-28) BID for a total of 28 days.
OG005
PF-06882961 120mg BID
PF-06882961 tablet was administered orally at 20 mg (Day 1-2), 40 mg (Day 3-4), 60 mg (Day 5-6), 80 mg (Day 7-9), 100 mg (Day 10-12) and 120 mg (Day 13-28) BID for a total of 28 days.
OG006
PF-06882961 120mg BID ST
PF-06882961 tablet was administered orally at 10 mg (Day 1-4), 20 mg (Day 5-8), 40 mg (Day 9-12), 60 mg (Day 13-16), 80 mg (Day 17-20), 100 mg (Day 21-24) and 120 mg (Day 25-28) BID for a total of 28 days.
OG007
PF-06882961 120mg QD
PF-06882961 tablet was administered orally at 10 mg (Day 1-2), 20 mg (Day 3-4), 30 mg (Day 5-6), 40 mg (Day 7-10), 60 mg (Day 11-14), 80 mg (Day 15-18), 100 mg (Day 19-22) and 120 mg (Day 23-28) QD for a total of 28 days.
OG008
PF-06882961 200mg QD CR
PF-06882961 CR tablet was administered orally at 50 mg (Day 1-7), 100 mg (Day 8-14), 150 mg (Day 15-21) and 200 mg (Day 22-28) QD for a total of 28 days.
Units
Counts
Participants
OG00025
OG0019
OG0029
OG003
Title
Denominators
Categories
PR interval ≥300 msec
Title
Measurements
OG0000
OG0010
OG0020
OG003
Secondary
AUC24 and AUCtau of PF-06882961 on Day 1, Day 14 or 21 and Day 28
Area under the concentration-time profile from time zero to time 24 hours (AUC24) was calculated as AUCtau1 +AUCtau2, where AUCtau was area under the plasma concentration-time profile from time zero to time tau (tau1 = 0 to 10 hours and tau2=10 to 24 hours). AUCtau was determined using linear/log trapezoidal method.
All randomized participants who received at least 1 dose of PF-06882961 and who had at least 1 of the PK parameters of interest.
Posted
Geometric Mean
Geometric Coefficient of Variation
nanogram.hours/milliliter (ng.h/mL)
0, 1, 2, 4, 6, 8, 10, 12, 14 and 24 hrs post dose on Day 1, 14 or 21, and 28
ID
Title
Description
OG000
PF-06882961 15mg BID (Cohort 1)
PF-06882961 tablet was administered orally at 15 mg BID for a total of 28 days.
OG001
PF-06882961 50mg BID (Cohort 2)
PF-06882961 tablet was administered orally at 50 mg BID for a total of 28 days.
OG002
PF-06882961 70mg BID (Cohort 3)
PF-06882961 tablet was administered orally at 20 mg (Day 1-3), 40 mg (Day 4-6), 50 mg (Day 7-9) and 70 mg (Day 10-28) BID for a total of 28 days.
OG003
PF-06882961 120mg BID (Cohort 4)
PF-06882961 tablet was administered orally at 20 mg (Day 1-2), 40 mg (Day 3-4), 60 mg (Day 5-6), 80 mg (Day 7-9), 100 mg (Day 10-12) and 120 mg (Day 13-28) BID for a total of 28 days.
OG004
PF-06882961 10mg BID (Cohort 5)
PF-06882961 tablet was administered orally at 5 mg BID from Day 1 to Day 14 followed by a dose of 10 mg BID from Day 15 to Day 28.
OG005
PF-06882961 120mg BID ST (Cohort 6)
PF-06882961 tablet was administered orally at 10 mg (Day 1-4), 20 mg (Day 5-8), 40 mg (Day 9-12), 60 mg (Day 13-16), 80 mg (Day 17-20), 100 mg (Day 21-24) and 120 mg (Day 25-28) BID for a total of 28 days.
OG006
PF-06882961 200mg QD CR (Cohort 7)
PF-06882961 CR tablet was administered orally at 50 mg (Day 1-7), 100 mg (Day 8-14), 150 mg (Day 15-21) and 200 mg (Day 22-28) QD for a total of 28 days.
OG007
PF-06882961 120mg QD (Cohort 8)
PF-06882961 tablet was administered orally at 10 mg (Day 1-2), 20 mg (Day 3-4), 30 mg (Day 5-6), 40 mg (Day 7-10), 60 mg (Day 11-14), 80 mg (Day 15-18), 100 mg (Day 19-22) and 120 mg (Day 23-28) QD for a total of 28 days.
Units
Counts
Participants
OG0009
OG00110
OG0029
OG003
Title
Denominators
Categories
AUC24 on Day 1
ParticipantsOG0009
ParticipantsOG00110
ParticipantsOG0029
ParticipantsOG003
Secondary
Maximum Plasma Concentration (Cmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28
For BID dosing, parameters were calculated for both dosing intervals (0-10 hr = interval 1 and 10-24 hr = interval 2) and were displayed as Cmax1, Cmax2.
Cmax1: maximum plasma concentration during the dosing interval τ1 =0 to 10 hours.
Cmax2: maximum plasma concentration during the dosing interval τ2=10 to 24 hours.
All randomized participants treated who had at least 1 measurable concentration value.
Posted
Geometric Mean
Geometric Coefficient of Variation
nanogram/milliliter (ng/mL)
0, 1, 2, 4, 6, 8, 10, 12, 14 and 24 hours post dose on Day 1, 14 or 21, and 28
ID
Title
Description
OG000
PF-06882961 15mg BID (Cohort 1)
PF-06882961 tablet was administered orally at 15 mg BID for a total of 28 days.
OG001
PF-06882961 50mg BID (Cohort 2)
PF-06882961 tablet was administered orally at 50 mg BID for a total of 28 days.
OG002
PF-06882961 70mg BID (Cohort 3)
PF-06882961 tablet was administered orally at 20 mg (Day 1-3), 40 mg (Day 4-6), 50 mg (Day 7-9) and 70 mg (Day 10-28) BID for a total of 28 days.
OG003
PF-06882961 120mg BID (Cohort 4)
PF-06882961 tablet was administered orally at 20 mg (Day 1-2), 40 mg (Day 3-4), 60 mg (Day 5-6), 80 mg (Day 7-9), 100 mg (Day 10-12) and 120 mg (Day 13-28) BID for a total of 28 days.
OG004
PF-06882961 10mg BID (Cohort 5)
PF-06882961 tablet was administered orally at 5 mg BID from Day 1 to Day 14 followed by a dose of 10 mg BID from Day 15 to Day 28.
OG005
PF-06882961 120mg BID ST (Cohort 6)
PF-06882961 tablet was administered orally at 10 mg (Day 1-4), 20 mg (Day 5-8), 40 mg (Day 9-12), 60 mg (Day 13-16), 80 mg (Day 17-20), 100 mg (Day 21-24) and 120 mg (Day 25-28) BID for a total of 28 days.
OG006
PF-06882961 200mg QD CR (Cohort 7)
PF-06882961 CR tablet was administered orally at 50 mg (Day 1-7), 100 mg (Day 8-14), 150 mg (Day 15-21) and 200 mg (Day 22-28) QD for a total of 28 days.
OG007
PF-06882961 120mg QD (Cohort 8)
PF-06882961 tablet was administered orally at 10 mg (Day 1-2), 20 mg (Day 3-4), 30 mg (Day 5-6), 40 mg (Day 7-10), 60 mg (Day 11-14), 80 mg (Day 15-18), 100 mg (Day 19-22) and 120 mg (Day 23-28) QD for a total of 28 days.
Units
Counts
Participants
OG0009
OG00110
OG0029
OG003
Title
Denominators
Categories
Cmax on Day 1
ParticipantsOG0009
ParticipantsOG00110
ParticipantsOG0029
ParticipantsOG003
Secondary
Time for Cmax (Tmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28
Time for Cmax, Cmax1 and Cmax2 (Tmax, Tmax1 and Tmax2) of PF-06293620 was observed directly from data as time of first occurrence.
All participants randomized and treated who had at least 1 of the PK parameters of interest.
Posted
Median
Full Range
hours
0, 1, 2, 4, 6, 8, 10, 12, 14 and 24 hrs post dose on Day 1, 14 or 21, and 28
ID
Title
Description
OG000
PF-06882961 15mg BID (Cohort 1)
PF-06882961 tablet was administered orally at 15 mg BID for a total of 28 days.
OG001
PF-06882961 50mg BID (Cohort 2)
PF-06882961 tablet was administered orally at 50 mg BID for a total of 28 days.
OG002
PF-06882961 70mg BID (Cohort 3)
PF-06882961 tablet was administered orally at 20 mg (Day 1-3), 40 mg (Day 4-6), 50 mg (Day 7-9) and 70 mg (Day 10-28) BID for a total of 28 days.
OG003
PF-06882961 120mg BID (Cohort 4)
PF-06882961 tablet was administered orally at 20 mg (Day 1-2), 40 mg (Day 3-4), 60 mg (Day 5-6), 80 mg (Day 7-9), 100 mg (Day 10-12) and 120 mg (Day 13-28) BID for a total of 28 days.
OG004
PF-06882961 10mg BID (Cohort 5)
PF-06882961 tablet was administered orally at 5 mg BID from Day 1 to Day 14 followed by a dose of 10 mg BID from Day 15 to Day 28.
OG005
PF-06882961 120mg BID ST (Cohort 6)
PF-06882961 tablet was administered orally at 10 mg (Day 1-4), 20 mg (Day 5-8), 40 mg (Day 9-12), 60 mg (Day 13-16), 80 mg (Day 17-20), 100 mg (Day 21-24) and 120 mg (Day 25-28) BID for a total of 28 days.
OG006
PF-06882961 200mg QD CR (Cohort 7)
PF-06882961 CR tablet was administered orally at 50 mg (Day 1-7), 100 mg (Day 8-14), 150 mg (Day 15-21) and 200 mg (Day 22-28) QD for a total of 28 days.
OG007
PF-06882961 120mg QD (Cohort 8)
PF-06882961 tablet was administered orally at 10 mg (Day 1-2), 20 mg (Day 3-4), 30 mg (Day 5-6), 40 mg (Day 7-10), 60 mg (Day 11-14), 80 mg (Day 15-18), 100 mg (Day 19-22) and 120 mg (Day 23-28) QD for a total of 28 days.
Units
Counts
Participants
OG0009
OG00110
OG0029
OG003
Title
Denominators
Categories
Tmax on Day 1
ParticipantsOG0009
ParticipantsOG00110
ParticipantsOG0029
ParticipantsOG003
Secondary
Terminal Half-life (t½) of PF-06882961 on Day 28
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
All participants randomized and treated who had at least 1 of the PK parameters of interest.
Posted
Mean
Standard Deviation
hours
0, 1, 2, 4, 6, 8, 10, 12, 14 and 24 hrs post dose on Day 28
ID
Title
Description
OG000
PF-06882961 15mg BID (Cohort 1)
PF-06882961 tablet was administered orally at 15 mg BID for a total of 28 days.
OG001
PF-06882961 50mg BID (Cohort 2)
PF-06882961 tablet was administered orally at 50 mg BID for a total of 28 days.
OG002
PF-06882961 70mg BID (Cohort 3)
PF-06882961 tablet was administered orally at 20 mg (Day 1-3), 40 mg (Day 4-6), 50 mg (Day 7-9) and 70 mg (Day 10-28) BID for a total of 28 days.
OG003
PF-06882961 120mg BID (Cohort 4)
PF-06882961 tablet was administered orally at 20 mg (Day 1-2), 40 mg (Day 3-4), 60 mg (Day 5-6), 80 mg (Day 7-9), 100 mg (Day 10-12) and 120 mg (Day 13-28) BID for a total of 28 days.
OG004
PF-06882961 10mg BID (Cohort 5)
PF-06882961 tablet was administered orally at 5 mg BID from Day 1 to Day 14 followed by a dose of 10 mg BID from Day 15 to Day 28.
OG005
PF-06882961 120mg BID ST (Cohort 6)
PF-06882961 tablet was administered orally at 10 mg (Day 1-4), 20 mg (Day 5-8), 40 mg (Day 9-12), 60 mg (Day 13-16), 80 mg (Day 17-20), 100 mg (Day 21-24) and 120 mg (Day 25-28) BID for a total of 28 days.
OG006
PF-06882961 200mg QD CR (Cohort 7)
PF-06882961 CR tablet was administered orally at 50 mg (Day 1-7), 100 mg (Day 8-14), 150 mg (Day 15-21) and 200 mg (Day 22-28) QD for a total of 28 days.
OG007
PF-06882961 120mg QD (Cohort 8)
PF-06882961 tablet was administered orally at 10 mg (Day 1-2), 20 mg (Day 3-4), 30 mg (Day 5-6), 40 mg (Day 7-10), 60 mg (Day 11-14), 80 mg (Day 15-18), 100 mg (Day 19-22) and 120 mg (Day 23-28) QD for a total of 28 days.
Units
Counts
Participants
OG0009
OG00110
OG0029
OG003
Title
Denominators
Categories
Title
Measurements
OG0005.100± 1.2186
OG0015.067± 0.75593
OG0024.681± 0.59504
OG003
Secondary
Amount of Unchanged Drug Recovered in Urine Over 24 Hours (Ae24) of PF-06882961 on Day 28
Ae was the cumulative amount of drug recovered unchanged in urine during the dosing interval, where the dosing interval was 24 hours. Cumulative amount was calculated as sum of urine drug concentration in sample volume for each collection interval. Sample volume = (urine weight in gram [g]/1.020), where 1.020 g/mL was the approximate specific gravity of urine.
All randomized participants who received at least 1 dose of PF-06882961 and who have at least 1 of the PK parameters of interest.
Posted
Geometric Mean
Geometric Coefficient of Variation
microgram
0 to 24 hours post-dose on Day 28
ID
Title
Description
OG000
PF-06882961 15mg BID (Cohort 1)
PF-06882961 tablet was administered orally at 15 mg BID for a total of 28 days.
OG001
PF-06882961 50mg BID (Cohort 2)
PF-06882961 tablet was administered orally at 50 mg BID for a total of 28 days.
OG002
PF-06882961 70mg BID (Cohort 3)
PF-06882961 tablet was administered orally at 20 mg (Day 1-3), 40 mg (Day 4-6), 50 mg (Day 7-9) and 70 mg (Day 10-28) BID for a total of 28 days.
OG003
PF-06882961 120mg BID (Cohort 4)
PF-06882961 tablet was administered orally at 20 mg (Day 1-2), 40 mg (Day 3-4), 60 mg (Day 5-6), 80 mg (Day 7-9), 100 mg (Day 10-12) and 120 mg (Day 13-28) BID for a total of 28 days.
OG004
PF-06882961 10mg BID (Cohort 5)
PF-06882961 tablet was administered orally at 5 mg BID from Day 1 to Day 14 followed by a dose of 10 mg BID from Day 15 to Day 28.
OG005
PF-06882961 120mg BID ST (Cohort 6)
PF-06882961 tablet was administered orally at 10 mg (Day 1-4), 20 mg (Day 5-8), 40 mg (Day 9-12), 60 mg (Day 13-16), 80 mg (Day 17-20), 100 mg (Day 21-24) and 120 mg (Day 25-28) BID for a total of 28 days.
OG006
PF-06882961 200mg QD CR (Cohort 7)
PF-06882961 CR tablet was administered orally at 50 mg (Day 1-7), 100 mg (Day 8-14), 150 mg (Day 15-21) and 200 mg (Day 22-28) QD for a total of 28 days.
OG007
PF-06882961 120mg QD (Cohort 8)
PF-06882961 tablet was administered orally at 10 mg (Day 1-2), 20 mg (Day 3-4), 30 mg (Day 5-6), 40 mg (Day 7-10), 60 mg (Day 11-14), 80 mg (Day 15-18), 100 mg (Day 19-22) and 120 mg (Day 23-28) QD for a total of 28 days.
Units
Counts
Participants
OG0009
OG00110
OG0029
OG003
Title
Denominators
Categories
Title
Measurements
OG00017.25± 36
OG00133.60± 69
OG00241.16± 243
OG003
Secondary
Ae24 (%) of PF-06882961 on Day 28
Percent of dose recovered in urine as unchanged drug. Ae24% = 100* Ae24/Dose
All randomized participants who received at least 1 dose of PF-06882961 and who have at least 1 of the PK parameters of interest.
Posted
Geometric Mean
Geometric Coefficient of Variation
Percentage
0 to 24 hours post-dose on Day 28
ID
Title
Description
OG000
PF-06882961 15mg BID (Cohort 1)
PF-06882961 tablet was administered orally at 15 mg BID for a total of 28 days.
OG001
PF-06882961 50mg BID (Cohort 2)
PF-06882961 tablet was administered orally at 50 mg BID for a total of 28 days.
OG002
PF-06882961 70mg BID (Cohort 3)
PF-06882961 tablet was administered orally at 20 mg (Day 1-3), 40 mg (Day 4-6), 50 mg (Day 7-9) and 70 mg (Day 10-28) BID for a total of 28 days.
OG003
PF-06882961 120mg BID (Cohort 4)
PF-06882961 tablet was administered orally at 20 mg (Day 1-2), 40 mg (Day 3-4), 60 mg (Day 5-6), 80 mg (Day 7-9), 100 mg (Day 10-12) and 120 mg (Day 13-28) BID for a total of 28 days.
OG004
PF-06882961 10mg BID (Cohort 5)
PF-06882961 tablet was administered orally at 5 mg BID from Day 1 to Day 14 followed by a dose of 10 mg BID from Day 15 to Day 28.
OG005
PF-06882961 120mg BID ST (Cohort 6)
PF-06882961 tablet was administered orally at 10 mg (Day 1-4), 20 mg (Day 5-8), 40 mg (Day 9-12), 60 mg (Day 13-16), 80 mg (Day 17-20), 100 mg (Day 21-24) and 120 mg (Day 25-28) BID for a total of 28 days.
OG006
PF-06882961 200mg QD CR (Cohort 7)
PF-06882961 CR tablet was administered orally at 50 mg (Day 1-7), 100 mg (Day 8-14), 150 mg (Day 15-21) and 200 mg (Day 22-28) QD for a total of 28 days.
OG007
PF-06882961 120mg QD (Cohort 8)
PF-06882961 tablet was administered orally at 10 mg (Day 1-2), 20 mg (Day 3-4), 30 mg (Day 5-6), 40 mg (Day 7-10), 60 mg (Day 11-14), 80 mg (Day 15-18), 100 mg (Day 19-22) and 120 mg (Day 23-28) QD for a total of 28 days.
Units
Counts
Participants
OG0009
OG00110
OG0029
OG003
Title
Denominators
Categories
Title
Measurements
OG0000.05747± 36
OG0010.03360± 69
OG0020.02942± 242
OG003
Secondary
Renal Clearance (CLr) of PF-06882961 on Day 28
CLr was calculated as Ae divided by AUCtau, where dosing interval is 24 hours.
All randomized participants who received at least 1 dose of PF-06882961 and who have at least 1 of the PK parameters of interest.
Posted
Geometric Mean
Geometric Coefficient of Variation
mL/min
0 to 24 hours post-dose on Day 28
ID
Title
Description
OG000
PF-06882961 15mg BID (Cohort 1)
PF-06882961 tablet was administered orally at 15 mg BID for a total of 28 days.
OG001
PF-06882961 50mg BID (Cohort 2)
PF-06882961 tablet was administered orally at 50 mg BID for a total of 28 days.
OG002
PF-06882961 70mg BID (Cohort 3)
PF-06882961 tablet was administered orally at 20 mg (Day 1-3), 40 mg (Day 4-6), 50 mg (Day 7-9) and 70 mg (Day 10-28) BID for a total of 28 days.
OG003
PF-06882961 120mg BID (Cohort 4)
PF-06882961 tablet was administered orally at 20 mg (Day 1-2), 40 mg (Day 3-4), 60 mg (Day 5-6), 80 mg (Day 7-9), 100 mg (Day 10-12) and 120 mg (Day 13-28) BID for a total of 28 days.
OG004
PF-06882961 10mg BID (Cohort 5)
PF-06882961 tablet was administered orally at 5 mg BID from Day 1 to Day 14 followed by a dose of 10 mg BID from Day 15 to Day 28.
OG005
PF-06882961 120mg BID ST (Cohort 6)
PF-06882961 tablet was administered orally at 10 mg (Day 1-4), 20 mg (Day 5-8), 40 mg (Day 9-12), 60 mg (Day 13-16), 80 mg (Day 17-20), 100 mg (Day 21-24) and 120 mg (Day 25-28) BID for a total of 28 days.
OG006
PF-06882961 200mg QD CR (Cohort 7)
PF-06882961 CR tablet was administered orally at 50 mg (Day 1-7), 100 mg (Day 8-14), 150 mg (Day 15-21) and 200 mg (Day 22-28) QD for a total of 28 days.
OG007
PF-06882961 120mg QD (Cohort 8)
PF-06882961 tablet was administered orally at 10 mg (Day 1-2), 20 mg (Day 3-4), 30 mg (Day 5-6), 40 mg (Day 7-10), 60 mg (Day 11-14), 80 mg (Day 15-18), 100 mg (Day 19-22) and 120 mg (Day 23-28) QD for a total of 28 days.
Units
Counts
Participants
OG0009
OG00110
OG0029
OG003
Title
Denominators
Categories
Title
Measurements
OG0000.3273± 18
OG0010.3385± 18
OG0020.3094± 70
OG003
0
25
0
25
15
25
EG001
PF-06882961 10mg BID
PF-06882961 tablet was administered orally at 5 mg BID from Day 1 to Day 14 followed by a dose of 10 mg BID from Day 15 to Day 28.
0
9
0
9
6
9
EG002
PF-06882961 15mg BID
PF-06882961 tablet was administered orally at 15 mg BID for a total of 28 days.
0
9
0
9
8
9
EG003
PF-06882961 50mg BID
PF-06882961 tablet was administered orally at 50 mg BID for a total of 28 days.
0
10
0
10
10
10
EG004
PF-06882961 70mg BID
PF-06882961 tablet was administered orally at 20 mg (Day 1-3), 40 mg (Day 4-6), 50 mg (Day 7-9) and 70 mg (Day 10-28) BID for a total of 28 days.
0
9
0
9
8
9
EG005
PF-06882961 120mg BID
PF-06882961 tablet was administered orally at 20 mg (Day 1-2), 40 mg (Day 3-4), 60 mg (Day 5-6), 80 mg (Day 7-9), 100 mg (Day 10-12) and 120 mg (Day 13-28) BID for a total of 28 days.
0
9
0
9
8
9
EG006
PF-06882961 120mg BID ST
PF-06882961 tablet was administered orally at 10 mg (Day 1-4), 20 mg (Day 5-8), 40 mg (Day 9-12), 60 mg (Day 13-16), 80 mg (Day 17-20), 100 mg (Day 21-24) and 120 mg (Day 25-28) BID for a total of 28 days.
0
9
1
9
9
9
EG007
PF-06882961 120mg QD
PF-06882961 tablet was administered orally at 10 mg (Day 1-2), 20 mg (Day 3-4), 30 mg (Day 5-6), 40 mg (Day 7-10), 60 mg (Day 11-14), 80 mg (Day 15-18), 100 mg (Day 19-22) and 120 mg (Day 23-28) QD for a total of 28 days.
0
8
0
8
8
8
EG008
PF-06882961 200mg QD CR
PF-06882961 CR tablet was administered orally at 50 mg (Day 1-7), 100 mg (Day 8-14), 150 mg (Day 15-21) and 200 mg (Day 22-28) QD for a total of 28 days.
0
10
0
10
9
10
EG0000 affected25 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG0030 affected10 at risk
EG0040 affected9 at risk
EG0050 affected9 at risk
EG0061 affected9 at risk
EG0070 affected8 at risk
EG0080 affected10 at risk
EG0000 affected25 at risk
EG0011 affected9 at risk
EG0020 affected9 at risk
EG0030 affected10 at risk
EG0040 affected9 at risk
EG0050 affected9 at risk
EG0060 affected9 at risk
EG0070 affected8 at risk
EG0080 affected10 at risk
Ear discomfort
Ear and labyrinth disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG0030 affected10 at risk
EG0040 affected9 at risk
EG0050 affected9 at risk
EG0060 affected9 at risk
EG0070 affected8 at risk
EG0081 affected10 at risk
Tinnitus
Ear and labyrinth disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG0030 affected10 at risk
EG0040 affected9 at risk
EG0050 affected9 at risk
EG0060 affected9 at risk
EG0070 affected8 at risk
EG0081 affected10 at risk
Dry eye
Eye disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG0032 affected10 at risk
EG0040 affected9 at risk
EG0050 affected9 at risk
EG0060 affected9 at risk
EG0070 affected8 at risk
EG0081 affected10 at risk
Vision blurred
Eye disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG0032 affected10 at risk
EG0041 affected9 at risk
EG0050 affected9 at risk
EG0060 affected9 at risk
EG0070 affected8 at risk
EG0080 affected10 at risk
Asthenia
General disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG0030 affected10 at risk
EG0040 affected9 at risk
EG0051 affected9 at risk
EG0060 affected9 at risk
EG0070 affected8 at risk
EG0080 affected10 at risk
Chest pain
General disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG0030 affected10 at risk
EG0040 affected9 at risk
EG0050 affected9 at risk
EG0061 affected9 at risk
EG0070 affected8 at risk
EG0080 affected10 at risk
Early satiety
General disorders
MedDRA v22.0
Non-systematic Assessment
EG0002 affected25 at risk
EG0011 affected9 at risk
EG0020 affected9 at risk
EG0035 affected10 at risk
EG0041 affected9 at risk
EG0050 affected9 at risk
EG0062 affected9 at risk
EG0071 affected8 at risk
EG0082 affected10 at risk
Fatigue
General disorders
MedDRA v22.0
Non-systematic Assessment
EG0001 affected25 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG0033 affected10 at risk
EG0040 affected9 at risk
EG0050 affected9 at risk
EG0060 affected9 at risk
EG0070 affected8 at risk
EG0080 affected10 at risk
Abdominal discomfort
Gastrointestinal disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG0030 affected10 at risk
EG0040 affected9 at risk
EG0052 affected9 at risk
EG0062 affected9 at risk
EG0071 affected8 at risk
EG0080 affected10 at risk
Abdominal distension
Gastrointestinal disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG0030 affected10 at risk
EG0043 affected9 at risk
EG0050 affected9 at risk
EG0060 affected9 at risk
EG0072 affected8 at risk
EG0080 affected10 at risk
Abdominal pain
Gastrointestinal disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0011 affected9 at risk
EG0021 affected9 at risk
EG0031 affected10 at risk
EG0040 affected9 at risk
EG0051 affected9 at risk
EG0060 affected9 at risk
EG0070 affected8 at risk
EG0080 affected10 at risk
Change of bowel habit
Gastrointestinal disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG0030 affected10 at risk
EG0040 affected9 at risk
EG0050 affected9 at risk
EG0060 affected9 at risk
EG0071 affected8 at risk
EG0080 affected10 at risk
Constipation
Gastrointestinal disorders
MedDRA v22.0
Non-systematic Assessment
EG0003 affected25 at risk
EG0012 affected9 at risk
EG0022 affected9 at risk
EG0031 affected10 at risk
EG0042 affected9 at risk
EG0051 affected9 at risk
EG0066 affected9 at risk
EG0071 affected8 at risk
EG0082 affected10 at risk
Diarrhoea
Gastrointestinal disorders
MedDRA v22.0
Non-systematic Assessment
EG0005 affected25 at risk
EG0010 affected9 at risk
EG0023 affected9 at risk
EG0032 affected10 at risk
EG0043 affected9 at risk
EG0054 affected9 at risk
EG0061 affected9 at risk
EG0072 affected8 at risk
EG0084 affected10 at risk
Dyspepsia
Gastrointestinal disorders
MedDRA v22.0
Non-systematic Assessment
EG0004 affected25 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG0035 affected10 at risk
EG0044 affected9 at risk
EG0054 affected9 at risk
EG0067 affected9 at risk
EG0073 affected8 at risk
EG0085 affected10 at risk
Eructation
Gastrointestinal disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG0032 affected10 at risk
EG0040 affected9 at risk
EG0051 affected9 at risk
EG0060 affected9 at risk
EG0070 affected8 at risk
EG0080 affected10 at risk
Flatulence
Gastrointestinal disorders
MedDRA v22.0
Non-systematic Assessment
EG0001 affected25 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG0030 affected0 at risk
EG0040 affected0 at risk
EG0050 affected9 at risk
EG0061 affected9 at risk
EG0070 affected8 at risk
EG0080 affected10 at risk
Gastrointestinal motility disorder
Gastrointestinal disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG0030 affected10 at risk
EG0040 affected9 at risk
EG0050 affected9 at risk
EG0060 affected9 at risk
EG0071 affected8 at risk
EG0080 affected10 at risk
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA v22.0
Non-systematic Assessment
EG0001 affected25 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG0031 affected10 at risk
EG0040 affected9 at risk
EG0050 affected9 at risk
EG0060 affected9 at risk
EG0071 affected8 at risk
EG0081 affected10 at risk
Gingivitis ulcerative
Gastrointestinal disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG0030 affected10 at risk
EG0040 affected9 at risk
EG0050 affected9 at risk
EG0060 affected9 at risk
EG0070 affected8 at risk
EG0081 affected10 at risk
Nausea
Gastrointestinal disorders
MedDRA v22.0
Non-systematic Assessment
EG0004 affected25 at risk
EG0010 affected9 at risk
EG0022 affected9 at risk
EG0037 affected10 at risk
EG0043 affected9 at risk
EG0058 affected9 at risk
EG0069 affected9 at risk
EG0077 affected8 at risk
EG0088 affected10 at risk
Retching
Gastrointestinal disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG0030 affected10 at risk
EG0040 affected9 at risk
EG0050 affected9 at risk
EG0061 affected9 at risk
EG0070 affected8 at risk
EG0080 affected10 at risk
Toothache
Gastrointestinal disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0011 affected9 at risk
EG0020 affected9 at risk
EG0030 affected10 at risk
EG0040 affected9 at risk
EG0050 affected9 at risk
EG0061 affected9 at risk
EG0070 affected8 at risk
EG0080 affected10 at risk
Vomiting
Gastrointestinal disorders
MedDRA v22.0
Non-systematic Assessment
EG0002 affected25 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG0032 affected10 at risk
EG0042 affected9 at risk
EG0057 affected9 at risk
EG0067 affected9 at risk
EG0073 affected8 at risk
EG0083 affected10 at risk
Tooth infection
Infections and infestations
MedDRA v22.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG0030 affected10 at risk
EG0040 affected9 at risk
EG0050 affected9 at risk
EG0061 affected9 at risk
EG0070 affected8 at risk
EG0080 affected10 at risk
Upper respiratory tract infection
Infections and infestations
MedDRA v22.0
Non-systematic Assessment
EG0002 affected25 at risk
EG0011 affected9 at risk
EG0020 affected9 at risk
EG0030 affected10 at risk
EG0040 affected9 at risk
EG0050 affected9 at risk
EG0060 affected9 at risk
EG0070 affected8 at risk
EG0080 affected10 at risk
Fall
Injury, poisoning and procedural complications
MedDRA v22.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected9 at risk
EG0021 affected9 at risk
EG0030 affected10 at risk
EG0040 affected9 at risk
EG0050 affected9 at risk
EG0060 affected9 at risk
EG0070 affected8 at risk
EG0080 affected10 at risk
Limb injury
Injury, poisoning and procedural complications
MedDRA v22.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG0030 affected10 at risk
EG0041 affected9 at risk
EG0050 affected9 at risk
EG0060 affected9 at risk
EG0070 affected8 at risk
EG0080 affected10 at risk
Road traffic accident
Injury, poisoning and procedural complications
MedDRA v22.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG0030 affected10 at risk
EG0041 affected9 at risk
EG0050 affected9 at risk
EG0060 affected9 at risk
EG0070 affected8 at risk
EG0080 affected10 at risk
Skin laceration
Injury, poisoning and procedural complications
MedDRA v22.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG0031 affected10 at risk
EG0040 affected9 at risk
EG0050 affected9 at risk
EG0060 affected9 at risk
EG0070 affected8 at risk
EG0080 affected10 at risk
Alanine aminotransferase increased
Investigations
MedDRA v22.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG0030 affected10 at risk
EG0040 affected9 at risk
EG0050 affected9 at risk
EG0061 affected9 at risk
EG0070 affected8 at risk
EG0082 affected10 at risk
Aspartate aminotransferase increased
Investigations
MedDRA v22.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG0030 affected10 at risk
EG0040 affected9 at risk
EG0050 affected9 at risk
EG0061 affected9 at risk
EG0070 affected8 at risk
EG0081 affected10 at risk
Blood creatinine increased
Investigations
MedDRA v22.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG0030 affected10 at risk
EG0041 affected9 at risk
EG0050 affected9 at risk
EG0060 affected9 at risk
EG0070 affected8 at risk
EG0080 affected10 at risk
Thyroid function test abnormal
Investigations
MedDRA v22.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG0030 affected10 at risk
EG0040 affected9 at risk
EG0051 affected9 at risk
EG0060 affected9 at risk
EG0070 affected8 at risk
EG0080 affected10 at risk
Weight decreased
Investigations
MedDRA v22.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG0031 affected10 at risk
EG0041 affected9 at risk
EG0052 affected9 at risk
EG0061 affected9 at risk
EG0072 affected8 at risk
EG0081 affected10 at risk
Decreased appetite
Metabolism and nutrition disorders
MedDRA v22.0
Non-systematic Assessment
EG0001 affected25 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG0031 affected10 at risk
EG0041 affected9 at risk
EG0056 affected9 at risk
EG0062 affected9 at risk
EG0073 affected8 at risk
EG0085 affected10 at risk
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG0030 affected10 at risk
EG0040 affected9 at risk
EG0051 affected9 at risk
EG0060 affected9 at risk
EG0070 affected8 at risk
EG0080 affected10 at risk
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG0030 affected10 at risk
EG0040 affected9 at risk
EG0050 affected9 at risk
EG0060 affected9 at risk
EG0071 affected8 at risk
EG0080 affected10 at risk
Back pain
Musculoskeletal and connective tissue disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected9 at risk
EG0022 affected9 at risk
EG0030 affected10 at risk
EG0040 affected9 at risk
EG0050 affected9 at risk
EG0060 affected9 at risk
EG0070 affected8 at risk
EG0080 affected10 at risk
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected9 at risk
EG0021 affected9 at risk
EG0030 affected10 at risk
EG0040 affected9 at risk
EG0050 affected9 at risk
EG0060 affected9 at risk
EG0070 affected8 at risk
EG0080 affected10 at risk
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG0030 affected10 at risk
EG0041 affected9 at risk
EG0050 affected9 at risk
EG0060 affected9 at risk
EG0070 affected8 at risk
EG0081 affected10 at risk
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG0030 affected10 at risk
EG0041 affected9 at risk
EG0050 affected9 at risk
EG0060 affected9 at risk
EG0070 affected8 at risk
EG0080 affected10 at risk
Dizziness
Nervous system disorders
MedDRA v22.0
Non-systematic Assessment
EG0001 affected25 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG0032 affected10 at risk
EG0042 affected9 at risk
EG0052 affected9 at risk
EG0062 affected9 at risk
EG0070 affected8 at risk
EG0081 affected10 at risk
Headache
Nervous system disorders
MedDRA v22.0
Non-systematic Assessment
EG0008 affected25 at risk
EG0010 affected9 at risk
EG0021 affected9 at risk
EG0035 affected10 at risk
EG0042 affected9 at risk
EG0050 affected9 at risk
EG0060 affected9 at risk
EG0074 affected8 at risk
EG0083 affected10 at risk
Paraesthesia
Nervous system disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG0030 affected10 at risk
EG0040 affected9 at risk
EG0050 affected9 at risk
EG0060 affected9 at risk
EG0070 affected8 at risk
EG0081 affected10 at risk
Tremor
Nervous system disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG0030 affected10 at risk
EG0041 affected9 at risk
EG0050 affected9 at risk
EG0060 affected9 at risk
EG0070 affected8 at risk
EG0080 affected10 at risk
Dysuria
Renal and urinary disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG0031 affected10 at risk
EG0040 affected9 at risk
EG0050 affected9 at risk
EG0060 affected9 at risk
EG0070 affected8 at risk
EG0080 affected10 at risk
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG0030 affected10 at risk
EG0040 affected9 at risk
EG0051 affected9 at risk
EG0060 affected9 at risk
EG0070 affected8 at risk
EG0080 affected10 at risk
Hiccups
Respiratory, thoracic and mediastinal disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG0030 affected10 at risk
EG0040 affected9 at risk
EG0050 affected9 at risk
EG0060 affected9 at risk
EG0070 affected8 at risk
EG0081 affected10 at risk
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG0030 affected10 at risk
EG0040 affected9 at risk
EG0050 affected9 at risk
EG0060 affected9 at risk
EG0070 affected8 at risk
EG0081 affected10 at risk
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG0030 affected10 at risk
EG0040 affected9 at risk
EG0050 affected9 at risk
EG0060 affected9 at risk
EG0071 affected8 at risk
EG0080 affected10 at risk
Acne
Skin and subcutaneous tissue disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG0030 affected10 at risk
EG0040 affected9 at risk
EG0050 affected9 at risk
EG0060 affected9 at risk
EG0070 affected8 at risk
EG0081 affected10 at risk
Blister
Skin and subcutaneous tissue disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0011 affected9 at risk
EG0020 affected9 at risk
EG0030 affected10 at risk
EG0040 affected9 at risk
EG0050 affected9 at risk
EG0060 affected9 at risk
EG0070 affected8 at risk
EG0080 affected10 at risk
Dermatitis contact
Skin and subcutaneous tissue disorders
MedDRA v22.0
Non-systematic Assessment
EG0002 affected25 at risk
EG0010 affected9 at risk
EG0021 affected9 at risk
EG0031 affected10 at risk
EG0040 affected9 at risk
EG0050 affected9 at risk
EG0060 affected9 at risk
EG0071 affected8 at risk
EG0080 affected10 at risk
Hyperhidrosis
Skin and subcutaneous tissue disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected9 at risk
EG0021 affected9 at risk
EG0030 affected10 at risk
EG0040 affected9 at risk
EG0051 affected9 at risk
EG0060 affected9 at risk
EG0070 affected8 at risk
EG0080 affected10 at risk
Rash
Skin and subcutaneous tissue disorders
MedDRA v22.0
Non-systematic Assessment
EG0001 affected25 at risk
EG0010 affected9 at risk
EG0021 affected9 at risk
EG0030 affected10 at risk
EG0040 affected9 at risk
EG0050 affected9 at risk
EG0062 affected9 at risk
EG0070 affected8 at risk
EG0080 affected10 at risk
Skin irritation
Skin and subcutaneous tissue disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected25 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG0030 affected10 at risk
EG0040 affected9 at risk
EG0050 affected9 at risk
EG0061 affected9 at risk
EG0070 affected8 at risk
EG0080 affected10 at risk
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
D004700
Endocrine System Diseases
8
BG0058
BG0067
BG0077
BG0088
BG00977
1
BG0050
BG0062
BG0071
BG0082
BG00917
4
BG0057
BG0064
BG0074
BG0085
BG00951
3
BG0055
BG0065
BG0072
BG0084
BG00937
0
BG0050
BG0060
BG0070
BG0080
BG0090
2
BG0053
BG0065
BG0070
BG0083
BG00927
0
BG0050
BG0060
BG0070
BG0080
BG0091
0
OG0040
OG0050
OG0061
OG0070
OG0080
10
OG0047
OG0058
OG0069
OG0078
OG0089
0
OG0040
OG0050
OG0060
OG0070
OG0080
10
OG0049
OG0059
OG0069
OG0078
OG00810
10
OG0048
OG0058
OG0069
OG0077
OG00810
10
OG0049
OG0059
OG0069
OG0078
OG00810
1
OG0043
OG0050
OG0063
OG0070
OG0081
Supine SBP increase >=30 mmHg
Title
Measurements
OG0004
OG0010
OG0020
OG0032
OG0043
OG0051
OG0062
OG0072
OG0081
Supine SBP decrease >=30 mmHg
Title
Measurements
OG0009
OG0012
OG0025
OG0033
OG0045
OG0053
OG0063
OG0075
OG0084
Supine DBP <50 mmHg
Title
Measurements
OG0001
OG0011
OG0022
OG0031
OG0041
OG0050
OG0062
OG0070
OG0080
Supine DBP increase >=20 mmHg
Title
Measurements
OG0001
OG0011
OG0021
OG0030
OG0044
OG0051
OG0062
OG0072
OG0081
Supine DBP decrease >=20 mmHg
Title
Measurements
OG0006
OG0012
OG0021
OG0032
OG0041
OG0053
OG0064
OG0072
OG0083
Supine pulse rate <40 bpm
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
Supine pulse rate >120 bpm
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
10
OG0049
OG0059
OG0069
OG0078
OG00810
0
OG0040
OG0050
OG0060
OG0070
OG0080
%Change in PR interval ≥25/50%
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
QRS duration ≥140 msec
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
%Change in QRS duration ≥50%
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
QTcF interval >450 and ≤480 msec
Title
Measurements
OG0002
OG0010
OG0021
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
QTcF interval >480 and ≤500 msec
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
QTcF interval >500 msec
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
Change in QTcF interval >30 and ≤60 msec
Title
Measurements
OG0000
OG0011
OG0020
OG0030
OG0040
OG0051
OG0060
OG0070
OG0080
Change in QTcF interval >60 msec
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
9
OG0049
OG0059
OG00610
OG0078
9
ParticipantsOG0049
ParticipantsOG0059
ParticipantsOG00610
ParticipantsOG0078
Title
Measurements
OG000707.5± 43
OG0011502± 29
OG002645.8± 52
OG003666.1± 54
OG004178.7± 72
OG005324.0± 41
OG006393.9± 80
OG007184.6± 49
AUCtau1 on Day 1
ParticipantsOG0009
ParticipantsOG00110
ParticipantsOG0029
ParticipantsOG0039
ParticipantsOG0049
ParticipantsOG0059
ParticipantsOG00610
ParticipantsOG0078
Title
Measurements
OG000288.1± 37
OG001741.4± 35
OG002279.7± 49
OG003
AUCtau2 on Day 1
ParticipantsOG0009
ParticipantsOG00110
ParticipantsOG0029
ParticipantsOG0039
ParticipantsOG0049
ParticipantsOG0059
ParticipantsOG00610
ParticipantsOG0078
Title
Measurements
OG000414.8± 50
OG001678.5± 79
OG002364.9± 56
OG003
AUC24 on Day 14 or 21
ParticipantsOG0008
ParticipantsOG0014
ParticipantsOG0029
ParticipantsOG0038
ParticipantsOG0049
ParticipantsOG0059
ParticipantsOG00610
ParticipantsOG0078
Title
Measurements
OG000853.8± 45
OG0012092± 91
OG0022988± 59
OG003
AUCtau1 on Day 14 or 21
ParticipantsOG0008
ParticipantsOG0014
ParticipantsOG0029
ParticipantsOG0038
ParticipantsOG0049
ParticipantsOG0059
ParticipantsOG00610
ParticipantsOG0078
Title
Measurements
OG000348.6± 48
OG001880.3± 78
OG0021462± 70
OG003
AUCtau2 on Day 14 or 21
ParticipantsOG0008
ParticipantsOG0014
ParticipantsOG0029
ParticipantsOG0038
ParticipantsOG0049
ParticipantsOG0059
ParticipantsOG00610
ParticipantsOG0078
Title
Measurements
OG000500.1± 46
OG0011175± 110
OG0021517± 53
OG003
AUC24 on Day 28
ParticipantsOG0008
ParticipantsOG0014
ParticipantsOG0028
ParticipantsOG0038
ParticipantsOG0049
ParticipantsOG0057
ParticipantsOG0067
ParticipantsOG0077
Title
Measurements
OG000876.7± 41
OG0011653± 55
OG0023171± 56
OG003
AUCtau1 on Day 28
ParticipantsOG0008
ParticipantsOG0014
ParticipantsOG0028
ParticipantsOG0038
ParticipantsOG0049
ParticipantsOG0057
ParticipantsOG0067
ParticipantsOG0078
Title
Measurements
OG000331.1± 40
OG001671.1± 35
OG0021153± 44
OG003
AUCtau2 on Day 28
ParticipantsOG0008
ParticipantsOG0014
ParticipantsOG0028
ParticipantsOG0038
ParticipantsOG0049
ParticipantsOG0057
ParticipantsOG0067
ParticipantsOG0078
Title
Measurements
OG000534.7± 46
OG001960.1± 73
OG0021970± 68
OG003
9
OG0049
OG0059
OG00610
OG0078
9
ParticipantsOG0049
ParticipantsOG0059
ParticipantsOG00610
ParticipantsOG0078
Title
Measurements
OG00050.58± 40
OG001124.4± 51
OG00249.75± 50
OG00351.61± 50
OG00415.02± 70
OG00526.02± 39
OG00628.67± 87
OG00720.40± 29
Cmax1 on Day 1
ParticipantsOG0009
ParticipantsOG00110
ParticipantsOG0029
ParticipantsOG0039
ParticipantsOG0049
ParticipantsOG0059
ParticipantsOG00610
ParticipantsOG0078
Title
Measurements
OG00042.69± 29
OG001119.1± 56
OG00245.01± 48
OG003
Cmax2 on Day 1
ParticipantsOG0009
ParticipantsOG00110
ParticipantsOG0029
ParticipantsOG0039
ParticipantsOG0049
ParticipantsOG0059
ParticipantsOG00610
ParticipantsOG0078
Title
Measurements
OG00040.63± 66
OG00168.77± 51
OG00242.33± 59
OG003
Cmax on Day 14 or 21
ParticipantsOG0008
ParticipantsOG0014
ParticipantsOG0029
ParticipantsOG0038
ParticipantsOG0049
ParticipantsOG0059
ParticipantsOG00610
ParticipantsOG0078
Title
Measurements
OG00065.78± 35
OG001149.8± 88
OG002253.6± 76
OG003
Cmax1 on Day 14 or 21
ParticipantsOG0008
ParticipantsOG0014
ParticipantsOG0029
ParticipantsOG0038
ParticipantsOG0049
ParticipantsOG0059
ParticipantsOG00610
ParticipantsOG0078
Title
Measurements
OG00055.00± 43
OG001130.2± 85
OG002235.1± 84
OG003
Cmax2 on Day 14 or 21
ParticipantsOG0008
ParticipantsOG0014
ParticipantsOG0029
ParticipantsOG0038
ParticipantsOG0049
ParticipantsOG0059
ParticipantsOG00610
ParticipantsOG0078
Title
Measurements
OG00063.89± 36
OG001127.9± 86
OG002202.8± 50
OG003
Cmax on Day 28
ParticipantsOG0008
ParticipantsOG0014
ParticipantsOG0028
ParticipantsOG0038
ParticipantsOG0049
ParticipantsOG0057
ParticipantsOG0067
ParticipantsOG0077
Title
Measurements
OG00081.56± 32
OG001133.7± 69
OG002328.8± 49
OG003
Cmax1 on Day 28
ParticipantsOG0008
ParticipantsOG0014
ParticipantsOG0028
ParticipantsOG0038
ParticipantsOG0049
ParticipantsOG0057
ParticipantsOG0067
ParticipantsOG0078
Title
Measurements
OG00050.24± 44
OG001103.8± 50
OG002197.9± 51
OG003
Cmax2 on Day 28
ParticipantsOG0008
ParticipantsOG0014
ParticipantsOG0028
ParticipantsOG0038
ParticipantsOG0049
ParticipantsOG0057
ParticipantsOG0067
ParticipantsOG0078
Title
Measurements
OG00074.22± 37
OG001117.2± 63
OG002306.5± 49
OG003
9
OG0049
OG0059
OG00610
OG0078
9
ParticipantsOG0049
ParticipantsOG0059
ParticipantsOG00610
ParticipantsOG0078
Title
Measurements
OG000NA(NA to NA)Data was calculated as Tmax1 and Tmax2 only for BID dosing.
OG001NA(NA to NA)Data was calculated as Tmax1 and Tmax2 only for BID dosing.
OG002NA(NA to NA)Data was calculated as Tmax1 and Tmax2 only for BID dosing.
OG003NA(NA to NA)Data was calculated as Tmax1 and Tmax2 only for BID dosing.
OG004NA(NA to NA)Data was calculated as Tmax1 and Tmax2 only for BID dosing.
OG005NA(NA to NA)Data was calculated as Tmax1 and Tmax2 only for BID dosing.
OG00613.0(8.00 to 23.9)
OG0073.00(1.00 to 6.00)
Tmax1 on Day 1
ParticipantsOG0009
ParticipantsOG00110
ParticipantsOG0029
ParticipantsOG0039
ParticipantsOG0049
ParticipantsOG0059
ParticipantsOG00610
ParticipantsOG0078
Title
Measurements
OG0004.00(2.00 to 8.00)
OG0014.00(1.00 to 6.00)
OG0022.00(1.00 to 6.00)
OG003
Tmax2 on Day 1
ParticipantsOG0009
ParticipantsOG00110
ParticipantsOG0029
ParticipantsOG0039
ParticipantsOG0049
ParticipantsOG0059
ParticipantsOG00610
ParticipantsOG0078
Title
Measurements
OG00014.0(10.0 to 24.0)
OG00114.0(10.0 to 24.0)
OG00214.0(12.0 to 14.0)
OG003
Tmax on Day 14 or 21
ParticipantsOG0008
ParticipantsOG0014
ParticipantsOG0029
ParticipantsOG0038
ParticipantsOG0049
ParticipantsOG0059
ParticipantsOG00610
ParticipantsOG0078
Title
Measurements
OG000NA(NA to NA)Data was calculated as Tmax1 and Tmax2 only for BID dosing.
OG001NA(NA to NA)Data was calculated as Tmax1 and Tmax2 only for BID dosing.
OG002NA(NA to NA)Data was calculated as Tmax1 and Tmax2 only for BID dosing.
OG003
Tmax1 on Day 14 or 21
ParticipantsOG0008
ParticipantsOG0014
ParticipantsOG0029
ParticipantsOG0038
ParticipantsOG0049
ParticipantsOG0059
ParticipantsOG00610
ParticipantsOG0078
Title
Measurements
OG0004.00(2.00 to 8.00)
OG0014.00(1.00 to 6.00)
OG0021.05(1.00 to 6.00)
OG003
Tmax2 on Day 14 or 21
ParticipantsOG0008
ParticipantsOG0014
ParticipantsOG0029
ParticipantsOG0038
ParticipantsOG0049
ParticipantsOG0059
ParticipantsOG00610
ParticipantsOG0078
Title
Measurements
OG00013.0(12.0 to 14.0)
OG00113.0(10.0 to 14.0)
OG00212.0(12.0 to 12.0)
OG003
Tmax on Day 28
ParticipantsOG0008
ParticipantsOG0014
ParticipantsOG0028
ParticipantsOG0038
ParticipantsOG0049
ParticipantsOG0057
ParticipantsOG0067
ParticipantsOG0077
Title
Measurements
OG000NA(NA to NA)Data was calculated as Tmax1 and Tmax2 only for BID dosing.
OG001NA(NA to NA)Data was calculated as Tmax1 and Tmax2 only for BID dosing.
OG002NA(NA to NA)Data was calculated as Tmax1 and Tmax2 only for BID dosing.
OG003
Tmax1 on Day 28
ParticipantsOG0008
ParticipantsOG0014
ParticipantsOG0028
ParticipantsOG0038
ParticipantsOG0049
ParticipantsOG0057
ParticipantsOG0067
ParticipantsOG0077
Title
Measurements
OG0005.00(4.00 to 8.00)
OG0013.00(0.00 to 8.00)
OG0026.00(2.00 to 8.00)
OG003
Tmax2 on Day 28
ParticipantsOG0008
ParticipantsOG0014
ParticipantsOG0028
ParticipantsOG0038
ParticipantsOG0049
ParticipantsOG0057
ParticipantsOG0067
ParticipantsOG0077
Title
Measurements
OG00012.0(12.0 to 14.0)
OG00112.0(12.0 to 12.0)
OG00212.0(12.0 to 14.0)
OG003
9
OG0049
OG0059
OG00610
OG0078
6.203
± 2.3505
OG0048.090± 3.3234
OG0056.730± 2.5056
OG0065.773± 1.4876
OG0074.954± 0.58819
8
OG0049
OG0057
OG0067
OG0078
NA
± NA
"NA" indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
OG00414.97± 67
OG00562.63± 439
OG00672.98± 38
OG00749.09± 97
8
OG0049
OG0057
OG0067
OG0078
NA
± NA
"NA" indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
OG0040.07483± 67
OG0050.02607± 439
OG0060.03652± 38
OG0070.04094± 97
8
OG0049
OG0057
OG0067
OG0078
NA
± NA
"NA" indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
OG0040.5470± 26
OG0050.2006± 228
OG0060.2895± 21
OG0070.3178± 73
260.3
± 45
OG00474.50± 66
OG005147.7± 43
OG006NA± NAData was calculated as AUC24 only for QD dosing.
OG007NA± NAData was calculated as AUC24 only for QD dosing.
401.9
± 62
OG004103.7± 76
OG005176.4± 42
OG006NA± NAData was calculated as AUC24 only for QD dosing.
OG007NA± NAData was calculated as AUC24 only for QD dosing.
8149
± 84
OG004201.6± 63
OG0052660± 76
OG0061291± 68
OG0071204± 43
3772
± 85
OG00485.57± 59
OG005957.3± 66
OG006NA± NAData was calculated as AUC24 only for QD dosing.
OG007NA± NAData was calculated as AUC24 only for QD dosing.
4361
± 89
OG004115.4± 68
OG0051693± 83
OG006NA± NAData was calculated as AUC24 only for QD dosing.
OG007NA± NAData was calculated as AUC24 only for QD dosing.
8368
± 79
OG004455.9± 66
OG0055973± 87
OG0064372± 31
OG0072723± 39
3534
± 87
OG004190.8± 60
OG0052249± 88
OG006NA± NAData was calculated as AUC24 only for QD dosing.
OG007NA± NAData was calculated as AUC24 only for QD dosing.
4852
± 74
OG004261.0± 72
OG0053668± 91
OG006NA± NAData was calculated as AUC24 only for QD dosing.
OG007NA± NAData was calculated as AUC24 only for QD dosing.
36.51
± 43
OG00412.82± 58
OG00524.06± 42
OG006NA± NAData was calculated as Cmax only for QD dosing.
OG007NA± NAData was calculated as Cmax only for QD dosing.
44.97
± 61
OG00413.98± 75
OG00521.64± 41
OG006NA± NAData was calculated as Cmax only for QD dosing.
OG007NA± NAData was calculated as Cmax only for QD dosing.
788.4
± 89
OG00418.63± 47
OG005188.5± 57
OG00698.11± 54
OG007100.7± 35
682.7
± 92
OG00415.31± 50
OG005143.0± 71
OG006NA± NAData was calculated as Cmax only for QD dosing.
OG007NA± NAData was calculated as Cmax only for QD dosing.
505.3
± 93
OG00417.16± 58
OG005178.4± 56
OG006NA± NAData was calculated as Cmax only for QD dosing.
OG007NA± NAData was calculated as Cmax only for QD dosing.
685.2
± 87
OG00438.38± 58
OG005437.6± 94
OG006303.9± 32
OG007192.2± 52
649.2
± 90
OG00430.42± 52
OG005357.1± 84
OG006NA± NAData was calculated as Cmax only for QD dosing.
OG007NA± NAData was calculated as Cmax only for QD dosing.
617.9
± 93
OG00435.01± 56
OG005410.3± 90
OG006NA± NAData was calculated as Cmax only for QD dosing.
OG007NA± NAData was calculated as Cmax only for QD dosing.
4.00
(2.00 to 6.00)
OG0042.00(1.00 to 2.00)
OG0052.00(1.00 to 4.00)
OG006NA(NA to NA)Data was calculated as Tmax only for QD dosing.
OG007NA(NA to NA)Data was calculated as Tmax only for QD dosing.
14.0
(12.0 to 24.0)
OG00412.0(12.0 to 14.0)
OG00514.0(12.0 to 24.0)
OG006NA(NA to NA)Data was calculated as Tmax only for QD dosing.
OG007NA(NA to NA)Data was calculated as Tmax only for QD dosing.
NA
(NA to NA)
Data was calculated as Tmax1 and Tmax2 only for BID dosing.
OG004NA(NA to NA)Data was calculated as Tmax1 and Tmax2 only for BID dosing.
OG005NA(NA to NA)Data was calculated as Tmax1 and Tmax2 only for BID dosing.
OG00612.0(6.00 to 14.0)
OG0076.00(4.00 to 10.0)
1.54
(1.00 to 6.00)
OG0046.00(1.00 to 6.00)
OG0056.00(4.00 to 10.0)
OG006NA(NA to NA)Data was calculated as Tmax only for QD dosing.
OG007NA(NA to NA)Data was calculated as Tmax only for QD dosing.
12.0
(10.0 to 14.0)
OG00412.0(12.0 to 14.0)
OG00514.0(12.0 to 24.0)
OG006NA(NA to NA)Data was calculated as Tmax only for QD dosing.
OG007NA(NA to NA)Data was calculated as Tmax only for QD dosing.
NA
(NA to NA)
Data was calculated as Tmax1 and Tmax2 only for BID dosing.
OG004NA(NA to NA)Data was calculated as Tmax1 and Tmax2 only for BID dosing.
OG005NA(NA to NA)Data was calculated as Tmax1 and Tmax2 only for BID dosing.
OG00614.0(8.00 to 14.0)
OG00710.0(6.00 to 14.0)
4.00
(1.00 to 6.00)
OG0044.00(2.00 to 8.00)
OG0056.00(4.00 to 10.0)
OG006NA(NA to NA)Data was calculated as Tmax only for QD dosing.
OG007NA(NA to NA)Data was calculated as Tmax only for QD dosing.
12.0
(12.0 to 14.0)
OG00412.0(12.0 to 14.0)
OG00512.0(10.0 to 14.0)
OG006NA(NA to NA)Data was calculated as Tmax only for QD dosing.
OG007NA(NA to NA)Data was calculated as Tmax only for QD dosing.