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4-Week, Multiple-dose, Dose-escalating Study In Patients With Type 2 Diabetes

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

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03538743
Enrollment
98
Registered
2018-05-29
Start date
2018-06-25
Completion date
2019-06-10
Last updated
2020-07-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes Mellitus

Keywords

Type 2 diabetes mellitus

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.

Interventions

DRUGPlacebo

Tablet, 0 mg, twice daily, 28 days

Tablet, 15 mg twice daily, 28 days

Sponsors

Pfizer
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

* Type 2 diabetes treated with a stable dose of metformin at least 500 mg * HbA1c value between 7.0 and 10.5%

Exclusion criteria

\- Type 1 diabetes or secondary forms of diabetes

Design outcomes

Primary

MeasureTime frameDescription
Number of Participants With All-causality and Treatment-related Treatment-emergent Adverse Events (TEAEs)From baseline to up to 35 days after last dose for a total of approximately 63 daysTreatment-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.
Number of Participants With Laboratory Abnormalities Without Regard to Baseline AbnormalityFrom baseline to up to 14 days after last dose for a total of approximately 42 daysFollowing laboratory parameters were assessed against pre-defined abnormality criteria: hematology (hemoglobin, hematocrit, erythrocytes, reticulocytes, platelets, leukocytes, lymphocytes, neutrophils, basophils, eosinophils, monocytes, activated partial thromboplastin time, prothrombin time \[PT\], PT/international normalized ratio, reticulocytes); chemistry (indirect bilirubin, direct bilirubin, protein, albumin, blood urea nitrogen, creatinine, creatine kinase, urate, calcium, sodium, potassium, chloride, bicarbonate, urine urobilinogen); urinalysis (pH, urine glucose, urine ketones, urine protein, urine hemoglobin, nitrites, leukocyte esterase, urine erythrocytes, urine leukocytes, urine hyaline casts, urine bilirubin).
Number of Participants With Abnormal Vital SignsFrom baseline to up to 14 days after last dose for a total of approximately 42 daysVital 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.
Number of Participants With Abnormal Electrocardiogram (ECG) IntervalFrom baseline to up to 14 days after last dose for a total of approximately 42 daysECG 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

Secondary

MeasureTime frameDescription
Amount of Unchanged Drug Recovered in Urine Over 24 Hours (Ae24) of PF-06882961 on Day 280 to 24 hours post-dose on Day 28Ae 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.
AUC24 and AUCtau of PF-06882961 on Day 1, Day 14 or 21 and Day 280, 1, 2, 4, 6, 8, 10, 12, 14 and 24 hrs post dose on Day 1, 14 or 21, and 28Area 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.
Renal Clearance (CLr) of PF-06882961 on Day 280 to 24 hours post-dose on Day 28CLr was calculated as Ae divided by AUCtau, where dosing interval is 24 hours.
Ae24 (%) of PF-06882961 on Day 280 to 24 hours post-dose on Day 28Percent of dose recovered in urine as unchanged drug. Ae24% = 100\* Ae24/Dose
Maximum Plasma Concentration (Cmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 280, 1, 2, 4, 6, 8, 10, 12, 14 and 24 hours post dose on Day 1, 14 or 21, and 28For 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.
Time for Cmax (Tmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 280, 1, 2, 4, 6, 8, 10, 12, 14 and 24 hrs post dose on Day 1, 14 or 21, and 28Time for Cmax, Cmax1 and Cmax2 (Tmax, Tmax1 and Tmax2) of PF-06293620 was observed directly from data as time of first occurrence.
Terminal Half-life (t½) of PF-06882961 on Day 280, 1, 2, 4, 6, 8, 10, 12, 14 and 24 hrs post dose on Day 28Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.

Countries

United States

Participant flow

Participants by arm

ArmCount
Placebo
Placebo matched to PF-06882961 was administered orally QD or BID(dependent upon corresponding study treatment regimen) for a total of 28 days.
25
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.
9
PF-06882961 15mg BID
PF-06882961 tablet was administered orally at 15 mg BID for a total of 28 days.
9
PF-06882961 50mg BID
PF-06882961 tablet was administered orally at 50 mg BID for a total of 28 days.
10
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.
9
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.
9
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.
9
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.
8
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.
10
Total98

Withdrawals & dropouts

PeriodReasonFG000FG001FG002FG003FG004FG005FG006FG007FG008
Overall StudyAdverse Event001100000
Overall StudyNon-Treatment-Related Reasons000000003
Overall StudyWithdrawal by Subject000100000

Baseline characteristics

CharacteristicPF-06882961 10mg BIDPF-06882961 15mg BIDPF-06882961 50mg BIDPF-06882961 70mg BIDPF-06882961 120mg BIDPF-06882961 120mg BID STPF-06882961 120mg QDPlaceboPF-06882961 200mg QD CRTotal
Age, Customized
18-44 years
1 Participants1 Participants0 Participants0 Participants1 Participants0 Participants0 Participants1 Participants0 Participants4 Participants
Age, Customized
45-64 years
8 Participants6 Participants6 Participants8 Participants8 Participants7 Participants7 Participants19 Participants8 Participants77 Participants
Age, Customized
>=65 years
0 Participants2 Participants4 Participants1 Participants0 Participants2 Participants1 Participants5 Participants2 Participants17 Participants
Age Range55.0 Years55.0 Years63.5 Years60.0 Years57.0 Years58.0 Years58.0 Years60.0 Years59.0 Years58.0 Years
Ethnicity (NIH/OMB)
Hispanic or Latino
6 Participants4 Participants7 Participants6 Participants4 Participants4 Participants6 Participants18 Participants6 Participants61 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
3 Participants5 Participants3 Participants3 Participants5 Participants5 Participants2 Participants7 Participants4 Participants37 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race/Ethnicity, Customized
Black or African American
2 Participants3 Participants2 Participants2 Participants3 Participants5 Participants0 Participants7 Participants3 Participants27 Participants
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
0 Participants1 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants1 Participants
Race/Ethnicity, Customized
White
7 Participants5 Participants8 Participants7 Participants6 Participants4 Participants8 Participants18 Participants7 Participants70 Participants
Sex: Female, Male
Female
2 Participants6 Participants5 Participants5 Participants2 Participants5 Participants4 Participants13 Participants5 Participants47 Participants
Sex: Female, Male
Male
7 Participants3 Participants5 Participants4 Participants7 Participants4 Participants4 Participants12 Participants5 Participants51 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
EG004
affected / at risk
EG005
affected / at risk
EG006
affected / at risk
EG007
affected / at risk
EG008
affected / at risk
deaths
Total, all-cause mortality
0 / 250 / 90 / 90 / 100 / 90 / 90 / 90 / 80 / 10
other
Total, other adverse events
15 / 256 / 98 / 910 / 108 / 98 / 99 / 98 / 89 / 10
serious
Total, serious adverse events
0 / 250 / 90 / 90 / 100 / 90 / 91 / 90 / 80 / 10

Outcome results

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

Time frame: From baseline to up to 14 days after last dose for a total of approximately 42 days

Population: All randomized participants who received at least 1 dose of randomized study treatment.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
PlaceboNumber of Participants With Abnormal Electrocardiogram (ECG) IntervalQTcF interval >450 and ≤480 msec2 Participants
PlaceboNumber of Participants With Abnormal Electrocardiogram (ECG) IntervalChange in QTcF interval >30 and ≤60 msec0 Participants
PlaceboNumber of Participants With Abnormal Electrocardiogram (ECG) Interval%Change in QRS duration ≥50%0 Participants
PlaceboNumber of Participants With Abnormal Electrocardiogram (ECG) IntervalQTcF interval >500 msec0 Participants
PlaceboNumber of Participants With Abnormal Electrocardiogram (ECG) IntervalChange in QTcF interval >60 msec0 Participants
PlaceboNumber of Participants With Abnormal Electrocardiogram (ECG) IntervalQTcF interval >480 and ≤500 msec0 Participants
PlaceboNumber of Participants With Abnormal Electrocardiogram (ECG) IntervalQRS duration ≥140 msec0 Participants
PlaceboNumber of Participants With Abnormal Electrocardiogram (ECG) Interval%Change in PR interval ≥25/50%0 Participants
PlaceboNumber of Participants With Abnormal Electrocardiogram (ECG) IntervalPR interval ≥300 msec0 Participants
PF-06882961 10mg BIDNumber of Participants With Abnormal Electrocardiogram (ECG) IntervalQTcF interval >450 and ≤480 msec0 Participants
PF-06882961 10mg BIDNumber of Participants With Abnormal Electrocardiogram (ECG) IntervalPR interval ≥300 msec0 Participants
PF-06882961 10mg BIDNumber of Participants With Abnormal Electrocardiogram (ECG) IntervalChange in QTcF interval >30 and ≤60 msec1 Participants
PF-06882961 10mg BIDNumber of Participants With Abnormal Electrocardiogram (ECG) Interval%Change in PR interval ≥25/50%0 Participants
PF-06882961 10mg BIDNumber of Participants With Abnormal Electrocardiogram (ECG) IntervalQRS duration ≥140 msec0 Participants
PF-06882961 10mg BIDNumber of Participants With Abnormal Electrocardiogram (ECG) IntervalQTcF interval >500 msec0 Participants
PF-06882961 10mg BIDNumber of Participants With Abnormal Electrocardiogram (ECG) Interval%Change in QRS duration ≥50%0 Participants
PF-06882961 10mg BIDNumber of Participants With Abnormal Electrocardiogram (ECG) IntervalChange in QTcF interval >60 msec0 Participants
PF-06882961 10mg BIDNumber of Participants With Abnormal Electrocardiogram (ECG) IntervalQTcF interval >480 and ≤500 msec0 Participants
PF-06882961 15mg BIDNumber of Participants With Abnormal Electrocardiogram (ECG) IntervalQTcF interval >450 and ≤480 msec1 Participants
PF-06882961 15mg BIDNumber of Participants With Abnormal Electrocardiogram (ECG) IntervalQRS duration ≥140 msec0 Participants
PF-06882961 15mg BIDNumber of Participants With Abnormal Electrocardiogram (ECG) IntervalPR interval ≥300 msec0 Participants
PF-06882961 15mg BIDNumber of Participants With Abnormal Electrocardiogram (ECG) IntervalChange in QTcF interval >60 msec0 Participants
PF-06882961 15mg BIDNumber of Participants With Abnormal Electrocardiogram (ECG) IntervalChange in QTcF interval >30 and ≤60 msec0 Participants
PF-06882961 15mg BIDNumber of Participants With Abnormal Electrocardiogram (ECG) Interval%Change in QRS duration ≥50%0 Participants
PF-06882961 15mg BIDNumber of Participants With Abnormal Electrocardiogram (ECG) Interval%Change in PR interval ≥25/50%0 Participants
PF-06882961 15mg BIDNumber of Participants With Abnormal Electrocardiogram (ECG) IntervalQTcF interval >500 msec0 Participants
PF-06882961 15mg BIDNumber of Participants With Abnormal Electrocardiogram (ECG) IntervalQTcF interval >480 and ≤500 msec0 Participants
PF-06882961 50mg BIDNumber of Participants With Abnormal Electrocardiogram (ECG) IntervalChange in QTcF interval >30 and ≤60 msec0 Participants
PF-06882961 50mg BIDNumber of Participants With Abnormal Electrocardiogram (ECG) Interval%Change in PR interval ≥25/50%0 Participants
PF-06882961 50mg BIDNumber of Participants With Abnormal Electrocardiogram (ECG) IntervalQTcF interval >500 msec0 Participants
PF-06882961 50mg BIDNumber of Participants With Abnormal Electrocardiogram (ECG) IntervalQRS duration ≥140 msec0 Participants
PF-06882961 50mg BIDNumber of Participants With Abnormal Electrocardiogram (ECG) IntervalQTcF interval >480 and ≤500 msec0 Participants
PF-06882961 50mg BIDNumber of Participants With Abnormal Electrocardiogram (ECG) IntervalQTcF interval >450 and ≤480 msec0 Participants
PF-06882961 50mg BIDNumber of Participants With Abnormal Electrocardiogram (ECG) IntervalPR interval ≥300 msec0 Participants
PF-06882961 50mg BIDNumber of Participants With Abnormal Electrocardiogram (ECG) IntervalChange in QTcF interval >60 msec0 Participants
PF-06882961 50mg BIDNumber of Participants With Abnormal Electrocardiogram (ECG) Interval%Change in QRS duration ≥50%0 Participants
PF-06882961 70mg BIDNumber of Participants With Abnormal Electrocardiogram (ECG) IntervalChange in QTcF interval >30 and ≤60 msec0 Participants
PF-06882961 70mg BIDNumber of Participants With Abnormal Electrocardiogram (ECG) IntervalQTcF interval >500 msec0 Participants
PF-06882961 70mg BIDNumber of Participants With Abnormal Electrocardiogram (ECG) Interval%Change in QRS duration ≥50%0 Participants
PF-06882961 70mg BIDNumber of Participants With Abnormal Electrocardiogram (ECG) IntervalPR interval ≥300 msec0 Participants
PF-06882961 70mg BIDNumber of Participants With Abnormal Electrocardiogram (ECG) IntervalQRS duration ≥140 msec0 Participants
PF-06882961 70mg BIDNumber of Participants With Abnormal Electrocardiogram (ECG) Interval%Change in PR interval ≥25/50%0 Participants
PF-06882961 70mg BIDNumber of Participants With Abnormal Electrocardiogram (ECG) IntervalQTcF interval >450 and ≤480 msec0 Participants
PF-06882961 70mg BIDNumber of Participants With Abnormal Electrocardiogram (ECG) IntervalQTcF interval >480 and ≤500 msec0 Participants
PF-06882961 70mg BIDNumber of Participants With Abnormal Electrocardiogram (ECG) IntervalChange in QTcF interval >60 msec0 Participants
PF-06882961 120mg BIDNumber of Participants With Abnormal Electrocardiogram (ECG) Interval%Change in QRS duration ≥50%0 Participants
PF-06882961 120mg BIDNumber of Participants With Abnormal Electrocardiogram (ECG) IntervalChange in QTcF interval >60 msec0 Participants
PF-06882961 120mg BIDNumber of Participants With Abnormal Electrocardiogram (ECG) IntervalPR interval ≥300 msec0 Participants
PF-06882961 120mg BIDNumber of Participants With Abnormal Electrocardiogram (ECG) Interval%Change in PR interval ≥25/50%0 Participants
PF-06882961 120mg BIDNumber of Participants With Abnormal Electrocardiogram (ECG) IntervalQRS duration ≥140 msec0 Participants
PF-06882961 120mg BIDNumber of Participants With Abnormal Electrocardiogram (ECG) IntervalQTcF interval >450 and ≤480 msec0 Participants
PF-06882961 120mg BIDNumber of Participants With Abnormal Electrocardiogram (ECG) IntervalQTcF interval >480 and ≤500 msec0 Participants
PF-06882961 120mg BIDNumber of Participants With Abnormal Electrocardiogram (ECG) IntervalQTcF interval >500 msec0 Participants
PF-06882961 120mg BIDNumber of Participants With Abnormal Electrocardiogram (ECG) IntervalChange in QTcF interval >30 and ≤60 msec1 Participants
PF-06882961 120mg BID STNumber of Participants With Abnormal Electrocardiogram (ECG) IntervalQRS duration ≥140 msec0 Participants
PF-06882961 120mg BID STNumber of Participants With Abnormal Electrocardiogram (ECG) IntervalChange in QTcF interval >60 msec0 Participants
PF-06882961 120mg BID STNumber of Participants With Abnormal Electrocardiogram (ECG) IntervalChange in QTcF interval >30 and ≤60 msec0 Participants
PF-06882961 120mg BID STNumber of Participants With Abnormal Electrocardiogram (ECG) Interval%Change in PR interval ≥25/50%0 Participants
PF-06882961 120mg BID STNumber of Participants With Abnormal Electrocardiogram (ECG) Interval%Change in QRS duration ≥50%0 Participants
PF-06882961 120mg BID STNumber of Participants With Abnormal Electrocardiogram (ECG) IntervalQTcF interval >500 msec0 Participants
PF-06882961 120mg BID STNumber of Participants With Abnormal Electrocardiogram (ECG) IntervalPR interval ≥300 msec0 Participants
PF-06882961 120mg BID STNumber of Participants With Abnormal Electrocardiogram (ECG) IntervalQTcF interval >480 and ≤500 msec0 Participants
PF-06882961 120mg BID STNumber of Participants With Abnormal Electrocardiogram (ECG) IntervalQTcF interval >450 and ≤480 msec0 Participants
PF-06882961 120mg QDNumber of Participants With Abnormal Electrocardiogram (ECG) IntervalQTcF interval >480 and ≤500 msec0 Participants
PF-06882961 120mg QDNumber of Participants With Abnormal Electrocardiogram (ECG) IntervalChange in QTcF interval >60 msec0 Participants
PF-06882961 120mg QDNumber of Participants With Abnormal Electrocardiogram (ECG) IntervalQTcF interval >450 and ≤480 msec0 Participants
PF-06882961 120mg QDNumber of Participants With Abnormal Electrocardiogram (ECG) IntervalQRS duration ≥140 msec0 Participants
PF-06882961 120mg QDNumber of Participants With Abnormal Electrocardiogram (ECG) Interval%Change in QRS duration ≥50%0 Participants
PF-06882961 120mg QDNumber of Participants With Abnormal Electrocardiogram (ECG) Interval%Change in PR interval ≥25/50%0 Participants
PF-06882961 120mg QDNumber of Participants With Abnormal Electrocardiogram (ECG) IntervalChange in QTcF interval >30 and ≤60 msec0 Participants
PF-06882961 120mg QDNumber of Participants With Abnormal Electrocardiogram (ECG) IntervalQTcF interval >500 msec0 Participants
PF-06882961 120mg QDNumber of Participants With Abnormal Electrocardiogram (ECG) IntervalPR interval ≥300 msec0 Participants
PF-06882961 200mg QD CRNumber of Participants With Abnormal Electrocardiogram (ECG) IntervalChange in QTcF interval >30 and ≤60 msec0 Participants
PF-06882961 200mg QD CRNumber of Participants With Abnormal Electrocardiogram (ECG) IntervalQRS duration ≥140 msec0 Participants
PF-06882961 200mg QD CRNumber of Participants With Abnormal Electrocardiogram (ECG) IntervalQTcF interval >480 and ≤500 msec0 Participants
PF-06882961 200mg QD CRNumber of Participants With Abnormal Electrocardiogram (ECG) Interval%Change in PR interval ≥25/50%0 Participants
PF-06882961 200mg QD CRNumber of Participants With Abnormal Electrocardiogram (ECG) Interval%Change in QRS duration ≥50%0 Participants
PF-06882961 200mg QD CRNumber of Participants With Abnormal Electrocardiogram (ECG) IntervalQTcF interval >500 msec0 Participants
PF-06882961 200mg QD CRNumber of Participants With Abnormal Electrocardiogram (ECG) IntervalPR interval ≥300 msec0 Participants
PF-06882961 200mg QD CRNumber of Participants With Abnormal Electrocardiogram (ECG) IntervalChange in QTcF interval >60 msec0 Participants
PF-06882961 200mg QD CRNumber of Participants With Abnormal Electrocardiogram (ECG) IntervalQTcF interval >450 and ≤480 msec0 Participants
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.

Time frame: From baseline to up to 14 days after last dose for a total of approximately 42 days

Population: All randomized participants who received at least 1 dose of randomized study treatment.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
PlaceboNumber of Participants With Abnormal Vital SignsSupine pulse rate >120 bpm0 Participants
PlaceboNumber of Participants With Abnormal Vital SignsSupine SBP <90 mmHg3 Participants
PlaceboNumber of Participants With Abnormal Vital SignsSupine SBP increase >=30 mmHg4 Participants
PlaceboNumber of Participants With Abnormal Vital SignsSupine DBP <50 mmHg1 Participants
PlaceboNumber of Participants With Abnormal Vital SignsSupine SBP decrease >=30 mmHg9 Participants
PlaceboNumber of Participants With Abnormal Vital SignsSupine DBP decrease >=20 mmHg6 Participants
PlaceboNumber of Participants With Abnormal Vital SignsSupine DBP increase >=20 mmHg1 Participants
PlaceboNumber of Participants With Abnormal Vital SignsSupine pulse rate <40 bpm0 Participants
PF-06882961 10mg BIDNumber of Participants With Abnormal Vital SignsSupine DBP decrease >=20 mmHg2 Participants
PF-06882961 10mg BIDNumber of Participants With Abnormal Vital SignsSupine DBP increase >=20 mmHg1 Participants
PF-06882961 10mg BIDNumber of Participants With Abnormal Vital SignsSupine pulse rate <40 bpm0 Participants
PF-06882961 10mg BIDNumber of Participants With Abnormal Vital SignsSupine SBP increase >=30 mmHg0 Participants
PF-06882961 10mg BIDNumber of Participants With Abnormal Vital SignsSupine SBP <90 mmHg3 Participants
PF-06882961 10mg BIDNumber of Participants With Abnormal Vital SignsSupine SBP decrease >=30 mmHg2 Participants
PF-06882961 10mg BIDNumber of Participants With Abnormal Vital SignsSupine pulse rate >120 bpm0 Participants
PF-06882961 10mg BIDNumber of Participants With Abnormal Vital SignsSupine DBP <50 mmHg1 Participants
PF-06882961 15mg BIDNumber of Participants With Abnormal Vital SignsSupine DBP decrease >=20 mmHg1 Participants
PF-06882961 15mg BIDNumber of Participants With Abnormal Vital SignsSupine pulse rate <40 bpm0 Participants
PF-06882961 15mg BIDNumber of Participants With Abnormal Vital SignsSupine SBP decrease >=30 mmHg5 Participants
PF-06882961 15mg BIDNumber of Participants With Abnormal Vital SignsSupine pulse rate >120 bpm0 Participants
PF-06882961 15mg BIDNumber of Participants With Abnormal Vital SignsSupine DBP <50 mmHg2 Participants
PF-06882961 15mg BIDNumber of Participants With Abnormal Vital SignsSupine DBP increase >=20 mmHg1 Participants
PF-06882961 15mg BIDNumber of Participants With Abnormal Vital SignsSupine SBP <90 mmHg2 Participants
PF-06882961 15mg BIDNumber of Participants With Abnormal Vital SignsSupine SBP increase >=30 mmHg0 Participants
PF-06882961 50mg BIDNumber of Participants With Abnormal Vital SignsSupine DBP decrease >=20 mmHg2 Participants
PF-06882961 50mg BIDNumber of Participants With Abnormal Vital SignsSupine DBP increase >=20 mmHg0 Participants
PF-06882961 50mg BIDNumber of Participants With Abnormal Vital SignsSupine SBP <90 mmHg1 Participants
PF-06882961 50mg BIDNumber of Participants With Abnormal Vital SignsSupine pulse rate <40 bpm0 Participants
PF-06882961 50mg BIDNumber of Participants With Abnormal Vital SignsSupine DBP <50 mmHg1 Participants
PF-06882961 50mg BIDNumber of Participants With Abnormal Vital SignsSupine SBP increase >=30 mmHg2 Participants
PF-06882961 50mg BIDNumber of Participants With Abnormal Vital SignsSupine SBP decrease >=30 mmHg3 Participants
PF-06882961 50mg BIDNumber of Participants With Abnormal Vital SignsSupine pulse rate >120 bpm0 Participants
PF-06882961 70mg BIDNumber of Participants With Abnormal Vital SignsSupine DBP <50 mmHg1 Participants
PF-06882961 70mg BIDNumber of Participants With Abnormal Vital SignsSupine pulse rate >120 bpm0 Participants
PF-06882961 70mg BIDNumber of Participants With Abnormal Vital SignsSupine SBP increase >=30 mmHg3 Participants
PF-06882961 70mg BIDNumber of Participants With Abnormal Vital SignsSupine SBP decrease >=30 mmHg5 Participants
PF-06882961 70mg BIDNumber of Participants With Abnormal Vital SignsSupine DBP increase >=20 mmHg4 Participants
PF-06882961 70mg BIDNumber of Participants With Abnormal Vital SignsSupine DBP decrease >=20 mmHg1 Participants
PF-06882961 70mg BIDNumber of Participants With Abnormal Vital SignsSupine SBP <90 mmHg3 Participants
PF-06882961 70mg BIDNumber of Participants With Abnormal Vital SignsSupine pulse rate <40 bpm0 Participants
PF-06882961 120mg BIDNumber of Participants With Abnormal Vital SignsSupine SBP increase >=30 mmHg1 Participants
PF-06882961 120mg BIDNumber of Participants With Abnormal Vital SignsSupine pulse rate >120 bpm0 Participants
PF-06882961 120mg BIDNumber of Participants With Abnormal Vital SignsSupine pulse rate <40 bpm0 Participants
PF-06882961 120mg BIDNumber of Participants With Abnormal Vital SignsSupine DBP decrease >=20 mmHg3 Participants
PF-06882961 120mg BIDNumber of Participants With Abnormal Vital SignsSupine DBP <50 mmHg0 Participants
PF-06882961 120mg BIDNumber of Participants With Abnormal Vital SignsSupine SBP decrease >=30 mmHg3 Participants
PF-06882961 120mg BIDNumber of Participants With Abnormal Vital SignsSupine SBP <90 mmHg0 Participants
PF-06882961 120mg BIDNumber of Participants With Abnormal Vital SignsSupine DBP increase >=20 mmHg1 Participants
PF-06882961 120mg BID STNumber of Participants With Abnormal Vital SignsSupine SBP decrease >=30 mmHg3 Participants
PF-06882961 120mg BID STNumber of Participants With Abnormal Vital SignsSupine DBP increase >=20 mmHg2 Participants
PF-06882961 120mg BID STNumber of Participants With Abnormal Vital SignsSupine SBP increase >=30 mmHg2 Participants
PF-06882961 120mg BID STNumber of Participants With Abnormal Vital SignsSupine pulse rate <40 bpm0 Participants
PF-06882961 120mg BID STNumber of Participants With Abnormal Vital SignsSupine DBP decrease >=20 mmHg4 Participants
PF-06882961 120mg BID STNumber of Participants With Abnormal Vital SignsSupine SBP <90 mmHg3 Participants
PF-06882961 120mg BID STNumber of Participants With Abnormal Vital SignsSupine pulse rate >120 bpm0 Participants
PF-06882961 120mg BID STNumber of Participants With Abnormal Vital SignsSupine DBP <50 mmHg2 Participants
PF-06882961 120mg QDNumber of Participants With Abnormal Vital SignsSupine pulse rate >120 bpm0 Participants
PF-06882961 120mg QDNumber of Participants With Abnormal Vital SignsSupine DBP increase >=20 mmHg2 Participants
PF-06882961 120mg QDNumber of Participants With Abnormal Vital SignsSupine SBP <90 mmHg0 Participants
PF-06882961 120mg QDNumber of Participants With Abnormal Vital SignsSupine SBP increase >=30 mmHg2 Participants
PF-06882961 120mg QDNumber of Participants With Abnormal Vital SignsSupine DBP <50 mmHg0 Participants
PF-06882961 120mg QDNumber of Participants With Abnormal Vital SignsSupine DBP decrease >=20 mmHg2 Participants
PF-06882961 120mg QDNumber of Participants With Abnormal Vital SignsSupine pulse rate <40 bpm0 Participants
PF-06882961 120mg QDNumber of Participants With Abnormal Vital SignsSupine SBP decrease >=30 mmHg5 Participants
PF-06882961 200mg QD CRNumber of Participants With Abnormal Vital SignsSupine DBP increase >=20 mmHg1 Participants
PF-06882961 200mg QD CRNumber of Participants With Abnormal Vital SignsSupine SBP <90 mmHg1 Participants
PF-06882961 200mg QD CRNumber of Participants With Abnormal Vital SignsSupine SBP increase >=30 mmHg1 Participants
PF-06882961 200mg QD CRNumber of Participants With Abnormal Vital SignsSupine SBP decrease >=30 mmHg4 Participants
PF-06882961 200mg QD CRNumber of Participants With Abnormal Vital SignsSupine DBP <50 mmHg0 Participants
PF-06882961 200mg QD CRNumber of Participants With Abnormal Vital SignsSupine DBP decrease >=20 mmHg3 Participants
PF-06882961 200mg QD CRNumber of Participants With Abnormal Vital SignsSupine pulse rate <40 bpm0 Participants
PF-06882961 200mg QD CRNumber of Participants With Abnormal Vital SignsSupine pulse rate >120 bpm0 Participants
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.

Time frame: From baseline to up to 35 days after last dose for a total of approximately 63 days

Population: All randomized participants who received at least 1 dose of randomized study treatment.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
PlaceboNumber of Participants With All-causality and Treatment-related Treatment-emergent Adverse Events (TEAEs)All-causality AE17 Participants
PlaceboNumber of Participants With All-causality and Treatment-related Treatment-emergent Adverse Events (TEAEs)All-causality SAE0 Participants
PlaceboNumber of Participants With All-causality and Treatment-related Treatment-emergent Adverse Events (TEAEs)Treatment-related AE14 Participants
PlaceboNumber of Participants With All-causality and Treatment-related Treatment-emergent Adverse Events (TEAEs)Treatment-related SAE0 Participants
PF-06882961 10mg BIDNumber of Participants With All-causality and Treatment-related Treatment-emergent Adverse Events (TEAEs)Treatment-related SAE0 Participants
PF-06882961 10mg BIDNumber of Participants With All-causality and Treatment-related Treatment-emergent Adverse Events (TEAEs)All-causality AE6 Participants
PF-06882961 10mg BIDNumber of Participants With All-causality and Treatment-related Treatment-emergent Adverse Events (TEAEs)All-causality SAE0 Participants
PF-06882961 10mg BIDNumber of Participants With All-causality and Treatment-related Treatment-emergent Adverse Events (TEAEs)Treatment-related AE4 Participants
PF-06882961 15mg BIDNumber of Participants With All-causality and Treatment-related Treatment-emergent Adverse Events (TEAEs)All-causality SAE0 Participants
PF-06882961 15mg BIDNumber of Participants With All-causality and Treatment-related Treatment-emergent Adverse Events (TEAEs)Treatment-related SAE0 Participants
PF-06882961 15mg BIDNumber of Participants With All-causality and Treatment-related Treatment-emergent Adverse Events (TEAEs)Treatment-related AE4 Participants
PF-06882961 15mg BIDNumber of Participants With All-causality and Treatment-related Treatment-emergent Adverse Events (TEAEs)All-causality AE8 Participants
PF-06882961 50mg BIDNumber of Participants With All-causality and Treatment-related Treatment-emergent Adverse Events (TEAEs)All-causality AE10 Participants
PF-06882961 50mg BIDNumber of Participants With All-causality and Treatment-related Treatment-emergent Adverse Events (TEAEs)All-causality SAE0 Participants
PF-06882961 50mg BIDNumber of Participants With All-causality and Treatment-related Treatment-emergent Adverse Events (TEAEs)Treatment-related AE10 Participants
PF-06882961 50mg BIDNumber of Participants With All-causality and Treatment-related Treatment-emergent Adverse Events (TEAEs)Treatment-related SAE0 Participants
PF-06882961 70mg BIDNumber of Participants With All-causality and Treatment-related Treatment-emergent Adverse Events (TEAEs)Treatment-related AE7 Participants
PF-06882961 70mg BIDNumber of Participants With All-causality and Treatment-related Treatment-emergent Adverse Events (TEAEs)All-causality SAE0 Participants
PF-06882961 70mg BIDNumber of Participants With All-causality and Treatment-related Treatment-emergent Adverse Events (TEAEs)All-causality AE8 Participants
PF-06882961 70mg BIDNumber of Participants With All-causality and Treatment-related Treatment-emergent Adverse Events (TEAEs)Treatment-related SAE0 Participants
PF-06882961 120mg BIDNumber of Participants With All-causality and Treatment-related Treatment-emergent Adverse Events (TEAEs)Treatment-related SAE0 Participants
PF-06882961 120mg BIDNumber of Participants With All-causality and Treatment-related Treatment-emergent Adverse Events (TEAEs)All-causality AE8 Participants
PF-06882961 120mg BIDNumber of Participants With All-causality and Treatment-related Treatment-emergent Adverse Events (TEAEs)Treatment-related AE8 Participants
PF-06882961 120mg BIDNumber of Participants With All-causality and Treatment-related Treatment-emergent Adverse Events (TEAEs)All-causality SAE0 Participants
PF-06882961 120mg BID STNumber of Participants With All-causality and Treatment-related Treatment-emergent Adverse Events (TEAEs)Treatment-related AE9 Participants
PF-06882961 120mg BID STNumber of Participants With All-causality and Treatment-related Treatment-emergent Adverse Events (TEAEs)All-causality SAE1 Participants
PF-06882961 120mg BID STNumber of Participants With All-causality and Treatment-related Treatment-emergent Adverse Events (TEAEs)Treatment-related SAE0 Participants
PF-06882961 120mg BID STNumber of Participants With All-causality and Treatment-related Treatment-emergent Adverse Events (TEAEs)All-causality AE9 Participants
PF-06882961 120mg QDNumber of Participants With All-causality and Treatment-related Treatment-emergent Adverse Events (TEAEs)All-causality SAE0 Participants
PF-06882961 120mg QDNumber of Participants With All-causality and Treatment-related Treatment-emergent Adverse Events (TEAEs)Treatment-related SAE0 Participants
PF-06882961 120mg QDNumber of Participants With All-causality and Treatment-related Treatment-emergent Adverse Events (TEAEs)Treatment-related AE8 Participants
PF-06882961 120mg QDNumber of Participants With All-causality and Treatment-related Treatment-emergent Adverse Events (TEAEs)All-causality AE8 Participants
PF-06882961 200mg QD CRNumber of Participants With All-causality and Treatment-related Treatment-emergent Adverse Events (TEAEs)All-causality AE9 Participants
PF-06882961 200mg QD CRNumber of Participants With All-causality and Treatment-related Treatment-emergent Adverse Events (TEAEs)Treatment-related SAE0 Participants
PF-06882961 200mg QD CRNumber of Participants With All-causality and Treatment-related Treatment-emergent Adverse Events (TEAEs)Treatment-related AE9 Participants
PF-06882961 200mg QD CRNumber of Participants With All-causality and Treatment-related Treatment-emergent Adverse Events (TEAEs)All-causality SAE0 Participants
Primary

Number of Participants With Laboratory Abnormalities Without Regard to Baseline Abnormality

Following laboratory parameters were assessed against pre-defined abnormality criteria: hematology (hemoglobin, hematocrit, erythrocytes, reticulocytes, platelets, leukocytes, lymphocytes, neutrophils, basophils, eosinophils, monocytes, activated partial thromboplastin time, prothrombin time \[PT\], PT/international normalized ratio, reticulocytes); chemistry (indirect bilirubin, direct bilirubin, protein, albumin, blood urea nitrogen, creatinine, creatine kinase, urate, calcium, sodium, potassium, chloride, bicarbonate, urine urobilinogen); urinalysis (pH, urine glucose, urine ketones, urine protein, urine hemoglobin, nitrites, leukocyte esterase, urine erythrocytes, urine leukocytes, urine hyaline casts, urine bilirubin).

Time frame: From baseline to up to 14 days after last dose for a total of approximately 42 days

Population: All randomized participants who received at least 1 dose of randomized study treatment.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
PlaceboNumber of Participants With Laboratory Abnormalities Without Regard to Baseline Abnormality24 Participants
PF-06882961 10mg BIDNumber of Participants With Laboratory Abnormalities Without Regard to Baseline Abnormality7 Participants
PF-06882961 15mg BIDNumber of Participants With Laboratory Abnormalities Without Regard to Baseline Abnormality8 Participants
PF-06882961 50mg BIDNumber of Participants With Laboratory Abnormalities Without Regard to Baseline Abnormality10 Participants
PF-06882961 70mg BIDNumber of Participants With Laboratory Abnormalities Without Regard to Baseline Abnormality8 Participants
PF-06882961 120mg BIDNumber of Participants With Laboratory Abnormalities Without Regard to Baseline Abnormality8 Participants
PF-06882961 120mg BID STNumber of Participants With Laboratory Abnormalities Without Regard to Baseline Abnormality9 Participants
PF-06882961 120mg QDNumber of Participants With Laboratory Abnormalities Without Regard to Baseline Abnormality7 Participants
PF-06882961 200mg QD CRNumber of Participants With Laboratory Abnormalities Without Regard to Baseline Abnormality10 Participants
Secondary

Ae24 (%) of PF-06882961 on Day 28

Percent of dose recovered in urine as unchanged drug. Ae24% = 100\* Ae24/Dose

Time frame: 0 to 24 hours post-dose on Day 28

Population: All randomized participants who received at least 1 dose of PF-06882961 and who have at least 1 of the PK parameters of interest.

ArmMeasureValue (GEOMETRIC_MEAN)Dispersion
PlaceboAe24 (%) of PF-06882961 on Day 280.05747 PercentageGeometric Coefficient of Variation 36
PF-06882961 10mg BIDAe24 (%) of PF-06882961 on Day 280.03360 PercentageGeometric Coefficient of Variation 69
PF-06882961 15mg BIDAe24 (%) of PF-06882961 on Day 280.02942 PercentageGeometric Coefficient of Variation 242
PF-06882961 50mg BIDAe24 (%) of PF-06882961 on Day 28NA Percentage
PF-06882961 70mg BIDAe24 (%) of PF-06882961 on Day 280.07483 PercentageGeometric Coefficient of Variation 67
PF-06882961 120mg BIDAe24 (%) of PF-06882961 on Day 280.02607 PercentageGeometric Coefficient of Variation 439
PF-06882961 120mg BID STAe24 (%) of PF-06882961 on Day 280.03652 PercentageGeometric Coefficient of Variation 38
PF-06882961 120mg QDAe24 (%) of PF-06882961 on Day 280.04094 PercentageGeometric Coefficient of Variation 97
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.

Time frame: 0 to 24 hours post-dose on Day 28

Population: All randomized participants who received at least 1 dose of PF-06882961 and who have at least 1 of the PK parameters of interest.

ArmMeasureValue (GEOMETRIC_MEAN)Dispersion
PlaceboAmount of Unchanged Drug Recovered in Urine Over 24 Hours (Ae24) of PF-06882961 on Day 2817.25 microgramGeometric Coefficient of Variation 36
PF-06882961 10mg BIDAmount of Unchanged Drug Recovered in Urine Over 24 Hours (Ae24) of PF-06882961 on Day 2833.60 microgramGeometric Coefficient of Variation 69
PF-06882961 15mg BIDAmount of Unchanged Drug Recovered in Urine Over 24 Hours (Ae24) of PF-06882961 on Day 2841.16 microgramGeometric Coefficient of Variation 243
PF-06882961 50mg BIDAmount of Unchanged Drug Recovered in Urine Over 24 Hours (Ae24) of PF-06882961 on Day 28NA microgram
PF-06882961 70mg BIDAmount of Unchanged Drug Recovered in Urine Over 24 Hours (Ae24) of PF-06882961 on Day 2814.97 microgramGeometric Coefficient of Variation 67
PF-06882961 120mg BIDAmount of Unchanged Drug Recovered in Urine Over 24 Hours (Ae24) of PF-06882961 on Day 2862.63 microgramGeometric Coefficient of Variation 439
PF-06882961 120mg BID STAmount of Unchanged Drug Recovered in Urine Over 24 Hours (Ae24) of PF-06882961 on Day 2872.98 microgramGeometric Coefficient of Variation 38
PF-06882961 120mg QDAmount of Unchanged Drug Recovered in Urine Over 24 Hours (Ae24) of PF-06882961 on Day 2849.09 microgramGeometric Coefficient of Variation 97
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.

Time frame: 0, 1, 2, 4, 6, 8, 10, 12, 14 and 24 hrs post dose on Day 1, 14 or 21, and 28

Population: All randomized participants who received at least 1 dose of PF-06882961 and who had at least 1 of the PK parameters of interest.

ArmMeasureGroupValue (GEOMETRIC_MEAN)Dispersion
PlaceboAUC24 and AUCtau of PF-06882961 on Day 1, Day 14 or 21 and Day 28AUC24 on Day 14 or 21853.8 nanogram.hours/milliliter (ng.h/mL)Geometric Coefficient of Variation 45
PlaceboAUC24 and AUCtau of PF-06882961 on Day 1, Day 14 or 21 and Day 28AUCtau1 on Day 1288.1 nanogram.hours/milliliter (ng.h/mL)Geometric Coefficient of Variation 37
PlaceboAUC24 and AUCtau of PF-06882961 on Day 1, Day 14 or 21 and Day 28AUCtau1 on Day 28331.1 nanogram.hours/milliliter (ng.h/mL)Geometric Coefficient of Variation 40
PlaceboAUC24 and AUCtau of PF-06882961 on Day 1, Day 14 or 21 and Day 28AUCtau2 on Day 14 or 21500.1 nanogram.hours/milliliter (ng.h/mL)Geometric Coefficient of Variation 46
PlaceboAUC24 and AUCtau of PF-06882961 on Day 1, Day 14 or 21 and Day 28AUCtau2 on Day 28534.7 nanogram.hours/milliliter (ng.h/mL)Geometric Coefficient of Variation 46
PlaceboAUC24 and AUCtau of PF-06882961 on Day 1, Day 14 or 21 and Day 28AUC24 on Day 28876.7 nanogram.hours/milliliter (ng.h/mL)Geometric Coefficient of Variation 41
PlaceboAUC24 and AUCtau of PF-06882961 on Day 1, Day 14 or 21 and Day 28AUCtau1 on Day 14 or 21348.6 nanogram.hours/milliliter (ng.h/mL)Geometric Coefficient of Variation 48
PlaceboAUC24 and AUCtau of PF-06882961 on Day 1, Day 14 or 21 and Day 28AUCtau2 on Day 1414.8 nanogram.hours/milliliter (ng.h/mL)Geometric Coefficient of Variation 50
PlaceboAUC24 and AUCtau of PF-06882961 on Day 1, Day 14 or 21 and Day 28AUC24 on Day 1707.5 nanogram.hours/milliliter (ng.h/mL)Geometric Coefficient of Variation 43
PF-06882961 10mg BIDAUC24 and AUCtau of PF-06882961 on Day 1, Day 14 or 21 and Day 28AUCtau2 on Day 1678.5 nanogram.hours/milliliter (ng.h/mL)Geometric Coefficient of Variation 79
PF-06882961 10mg BIDAUC24 and AUCtau of PF-06882961 on Day 1, Day 14 or 21 and Day 28AUC24 on Day 281653 nanogram.hours/milliliter (ng.h/mL)Geometric Coefficient of Variation 55
PF-06882961 10mg BIDAUC24 and AUCtau of PF-06882961 on Day 1, Day 14 or 21 and Day 28AUC24 on Day 11502 nanogram.hours/milliliter (ng.h/mL)Geometric Coefficient of Variation 29
PF-06882961 10mg BIDAUC24 and AUCtau of PF-06882961 on Day 1, Day 14 or 21 and Day 28AUCtau1 on Day 28671.1 nanogram.hours/milliliter (ng.h/mL)Geometric Coefficient of Variation 35
PF-06882961 10mg BIDAUC24 and AUCtau of PF-06882961 on Day 1, Day 14 or 21 and Day 28AUC24 on Day 14 or 212092 nanogram.hours/milliliter (ng.h/mL)Geometric Coefficient of Variation 91
PF-06882961 10mg BIDAUC24 and AUCtau of PF-06882961 on Day 1, Day 14 or 21 and Day 28AUCtau1 on Day 14 or 21880.3 nanogram.hours/milliliter (ng.h/mL)Geometric Coefficient of Variation 78
PF-06882961 10mg BIDAUC24 and AUCtau of PF-06882961 on Day 1, Day 14 or 21 and Day 28AUCtau2 on Day 28960.1 nanogram.hours/milliliter (ng.h/mL)Geometric Coefficient of Variation 73
PF-06882961 10mg BIDAUC24 and AUCtau of PF-06882961 on Day 1, Day 14 or 21 and Day 28AUCtau1 on Day 1741.4 nanogram.hours/milliliter (ng.h/mL)Geometric Coefficient of Variation 35
PF-06882961 10mg BIDAUC24 and AUCtau of PF-06882961 on Day 1, Day 14 or 21 and Day 28AUCtau2 on Day 14 or 211175 nanogram.hours/milliliter (ng.h/mL)Geometric Coefficient of Variation 110
PF-06882961 15mg BIDAUC24 and AUCtau of PF-06882961 on Day 1, Day 14 or 21 and Day 28AUCtau2 on Day 1364.9 nanogram.hours/milliliter (ng.h/mL)Geometric Coefficient of Variation 56
PF-06882961 15mg BIDAUC24 and AUCtau of PF-06882961 on Day 1, Day 14 or 21 and Day 28AUCtau2 on Day 14 or 211517 nanogram.hours/milliliter (ng.h/mL)Geometric Coefficient of Variation 53
PF-06882961 15mg BIDAUC24 and AUCtau of PF-06882961 on Day 1, Day 14 or 21 and Day 28AUCtau2 on Day 281970 nanogram.hours/milliliter (ng.h/mL)Geometric Coefficient of Variation 68
PF-06882961 15mg BIDAUC24 and AUCtau of PF-06882961 on Day 1, Day 14 or 21 and Day 28AUCtau1 on Day 1279.7 nanogram.hours/milliliter (ng.h/mL)Geometric Coefficient of Variation 49
PF-06882961 15mg BIDAUC24 and AUCtau of PF-06882961 on Day 1, Day 14 or 21 and Day 28AUC24 on Day 1645.8 nanogram.hours/milliliter (ng.h/mL)Geometric Coefficient of Variation 52
PF-06882961 15mg BIDAUC24 and AUCtau of PF-06882961 on Day 1, Day 14 or 21 and Day 28AUCtau1 on Day 281153 nanogram.hours/milliliter (ng.h/mL)Geometric Coefficient of Variation 44
PF-06882961 15mg BIDAUC24 and AUCtau of PF-06882961 on Day 1, Day 14 or 21 and Day 28AUC24 on Day 283171 nanogram.hours/milliliter (ng.h/mL)Geometric Coefficient of Variation 56
PF-06882961 15mg BIDAUC24 and AUCtau of PF-06882961 on Day 1, Day 14 or 21 and Day 28AUC24 on Day 14 or 212988 nanogram.hours/milliliter (ng.h/mL)Geometric Coefficient of Variation 59
PF-06882961 15mg BIDAUC24 and AUCtau of PF-06882961 on Day 1, Day 14 or 21 and Day 28AUCtau1 on Day 14 or 211462 nanogram.hours/milliliter (ng.h/mL)Geometric Coefficient of Variation 70
PF-06882961 50mg BIDAUC24 and AUCtau of PF-06882961 on Day 1, Day 14 or 21 and Day 28AUC24 on Day 14 or 218149 nanogram.hours/milliliter (ng.h/mL)Geometric Coefficient of Variation 84
PF-06882961 50mg BIDAUC24 and AUCtau of PF-06882961 on Day 1, Day 14 or 21 and Day 28AUC24 on Day 1666.1 nanogram.hours/milliliter (ng.h/mL)Geometric Coefficient of Variation 54
PF-06882961 50mg BIDAUC24 and AUCtau of PF-06882961 on Day 1, Day 14 or 21 and Day 28AUCtau2 on Day 1401.9 nanogram.hours/milliliter (ng.h/mL)Geometric Coefficient of Variation 62
PF-06882961 50mg BIDAUC24 and AUCtau of PF-06882961 on Day 1, Day 14 or 21 and Day 28AUCtau1 on Day 283534 nanogram.hours/milliliter (ng.h/mL)Geometric Coefficient of Variation 87
PF-06882961 50mg BIDAUC24 and AUCtau of PF-06882961 on Day 1, Day 14 or 21 and Day 28AUCtau1 on Day 1260.3 nanogram.hours/milliliter (ng.h/mL)Geometric Coefficient of Variation 45
PF-06882961 50mg BIDAUC24 and AUCtau of PF-06882961 on Day 1, Day 14 or 21 and Day 28AUCtau2 on Day 284852 nanogram.hours/milliliter (ng.h/mL)Geometric Coefficient of Variation 74
PF-06882961 50mg BIDAUC24 and AUCtau of PF-06882961 on Day 1, Day 14 or 21 and Day 28AUCtau2 on Day 14 or 214361 nanogram.hours/milliliter (ng.h/mL)Geometric Coefficient of Variation 89
PF-06882961 50mg BIDAUC24 and AUCtau of PF-06882961 on Day 1, Day 14 or 21 and Day 28AUC24 on Day 288368 nanogram.hours/milliliter (ng.h/mL)Geometric Coefficient of Variation 79
PF-06882961 50mg BIDAUC24 and AUCtau of PF-06882961 on Day 1, Day 14 or 21 and Day 28AUCtau1 on Day 14 or 213772 nanogram.hours/milliliter (ng.h/mL)Geometric Coefficient of Variation 85
PF-06882961 70mg BIDAUC24 and AUCtau of PF-06882961 on Day 1, Day 14 or 21 and Day 28AUCtau1 on Day 14 or 2185.57 nanogram.hours/milliliter (ng.h/mL)Geometric Coefficient of Variation 59
PF-06882961 70mg BIDAUC24 and AUCtau of PF-06882961 on Day 1, Day 14 or 21 and Day 28AUC24 on Day 1178.7 nanogram.hours/milliliter (ng.h/mL)Geometric Coefficient of Variation 72
PF-06882961 70mg BIDAUC24 and AUCtau of PF-06882961 on Day 1, Day 14 or 21 and Day 28AUCtau1 on Day 174.50 nanogram.hours/milliliter (ng.h/mL)Geometric Coefficient of Variation 66
PF-06882961 70mg BIDAUC24 and AUCtau of PF-06882961 on Day 1, Day 14 or 21 and Day 28AUCtau2 on Day 1103.7 nanogram.hours/milliliter (ng.h/mL)Geometric Coefficient of Variation 76
PF-06882961 70mg BIDAUC24 and AUCtau of PF-06882961 on Day 1, Day 14 or 21 and Day 28AUC24 on Day 14 or 21201.6 nanogram.hours/milliliter (ng.h/mL)Geometric Coefficient of Variation 63
PF-06882961 70mg BIDAUC24 and AUCtau of PF-06882961 on Day 1, Day 14 or 21 and Day 28AUCtau2 on Day 14 or 21115.4 nanogram.hours/milliliter (ng.h/mL)Geometric Coefficient of Variation 68
PF-06882961 70mg BIDAUC24 and AUCtau of PF-06882961 on Day 1, Day 14 or 21 and Day 28AUC24 on Day 28455.9 nanogram.hours/milliliter (ng.h/mL)Geometric Coefficient of Variation 66
PF-06882961 70mg BIDAUC24 and AUCtau of PF-06882961 on Day 1, Day 14 or 21 and Day 28AUCtau1 on Day 28190.8 nanogram.hours/milliliter (ng.h/mL)Geometric Coefficient of Variation 60
PF-06882961 70mg BIDAUC24 and AUCtau of PF-06882961 on Day 1, Day 14 or 21 and Day 28AUCtau2 on Day 28261.0 nanogram.hours/milliliter (ng.h/mL)Geometric Coefficient of Variation 72
PF-06882961 120mg BIDAUC24 and AUCtau of PF-06882961 on Day 1, Day 14 or 21 and Day 28AUC24 on Day 285973 nanogram.hours/milliliter (ng.h/mL)Geometric Coefficient of Variation 87
PF-06882961 120mg BIDAUC24 and AUCtau of PF-06882961 on Day 1, Day 14 or 21 and Day 28AUC24 on Day 1324.0 nanogram.hours/milliliter (ng.h/mL)Geometric Coefficient of Variation 41
PF-06882961 120mg BIDAUC24 and AUCtau of PF-06882961 on Day 1, Day 14 or 21 and Day 28AUCtau2 on Day 283668 nanogram.hours/milliliter (ng.h/mL)Geometric Coefficient of Variation 91
PF-06882961 120mg BIDAUC24 and AUCtau of PF-06882961 on Day 1, Day 14 or 21 and Day 28AUCtau2 on Day 1176.4 nanogram.hours/milliliter (ng.h/mL)Geometric Coefficient of Variation 42
PF-06882961 120mg BIDAUC24 and AUCtau of PF-06882961 on Day 1, Day 14 or 21 and Day 28AUC24 on Day 14 or 212660 nanogram.hours/milliliter (ng.h/mL)Geometric Coefficient of Variation 76
PF-06882961 120mg BIDAUC24 and AUCtau of PF-06882961 on Day 1, Day 14 or 21 and Day 28AUCtau1 on Day 1147.7 nanogram.hours/milliliter (ng.h/mL)Geometric Coefficient of Variation 43
PF-06882961 120mg BIDAUC24 and AUCtau of PF-06882961 on Day 1, Day 14 or 21 and Day 28AUCtau1 on Day 14 or 21957.3 nanogram.hours/milliliter (ng.h/mL)Geometric Coefficient of Variation 66
PF-06882961 120mg BIDAUC24 and AUCtau of PF-06882961 on Day 1, Day 14 or 21 and Day 28AUCtau1 on Day 282249 nanogram.hours/milliliter (ng.h/mL)Geometric Coefficient of Variation 88
PF-06882961 120mg BIDAUC24 and AUCtau of PF-06882961 on Day 1, Day 14 or 21 and Day 28AUCtau2 on Day 14 or 211693 nanogram.hours/milliliter (ng.h/mL)Geometric Coefficient of Variation 83
PF-06882961 120mg BID STAUC24 and AUCtau of PF-06882961 on Day 1, Day 14 or 21 and Day 28AUCtau1 on Day 28NA nanogram.hours/milliliter (ng.h/mL)
PF-06882961 120mg BID STAUC24 and AUCtau of PF-06882961 on Day 1, Day 14 or 21 and Day 28AUCtau2 on Day 1NA nanogram.hours/milliliter (ng.h/mL)
PF-06882961 120mg BID STAUC24 and AUCtau of PF-06882961 on Day 1, Day 14 or 21 and Day 28AUC24 on Day 1393.9 nanogram.hours/milliliter (ng.h/mL)Geometric Coefficient of Variation 80
PF-06882961 120mg BID STAUC24 and AUCtau of PF-06882961 on Day 1, Day 14 or 21 and Day 28AUCtau1 on Day 14 or 21NA nanogram.hours/milliliter (ng.h/mL)
PF-06882961 120mg BID STAUC24 and AUCtau of PF-06882961 on Day 1, Day 14 or 21 and Day 28AUC24 on Day 284372 nanogram.hours/milliliter (ng.h/mL)Geometric Coefficient of Variation 31
PF-06882961 120mg BID STAUC24 and AUCtau of PF-06882961 on Day 1, Day 14 or 21 and Day 28AUC24 on Day 14 or 211291 nanogram.hours/milliliter (ng.h/mL)Geometric Coefficient of Variation 68
PF-06882961 120mg BID STAUC24 and AUCtau of PF-06882961 on Day 1, Day 14 or 21 and Day 28AUCtau1 on Day 1NA nanogram.hours/milliliter (ng.h/mL)
PF-06882961 120mg BID STAUC24 and AUCtau of PF-06882961 on Day 1, Day 14 or 21 and Day 28AUCtau2 on Day 28NA nanogram.hours/milliliter (ng.h/mL)
PF-06882961 120mg BID STAUC24 and AUCtau of PF-06882961 on Day 1, Day 14 or 21 and Day 28AUCtau2 on Day 14 or 21NA nanogram.hours/milliliter (ng.h/mL)
PF-06882961 120mg QDAUC24 and AUCtau of PF-06882961 on Day 1, Day 14 or 21 and Day 28AUCtau2 on Day 28NA nanogram.hours/milliliter (ng.h/mL)
PF-06882961 120mg QDAUC24 and AUCtau of PF-06882961 on Day 1, Day 14 or 21 and Day 28AUC24 on Day 14 or 211204 nanogram.hours/milliliter (ng.h/mL)Geometric Coefficient of Variation 43
PF-06882961 120mg QDAUC24 and AUCtau of PF-06882961 on Day 1, Day 14 or 21 and Day 28AUCtau2 on Day 14 or 21NA nanogram.hours/milliliter (ng.h/mL)
PF-06882961 120mg QDAUC24 and AUCtau of PF-06882961 on Day 1, Day 14 or 21 and Day 28AUCtau2 on Day 1NA nanogram.hours/milliliter (ng.h/mL)
PF-06882961 120mg QDAUC24 and AUCtau of PF-06882961 on Day 1, Day 14 or 21 and Day 28AUC24 on Day 282723 nanogram.hours/milliliter (ng.h/mL)Geometric Coefficient of Variation 39
PF-06882961 120mg QDAUC24 and AUCtau of PF-06882961 on Day 1, Day 14 or 21 and Day 28AUCtau1 on Day 1NA nanogram.hours/milliliter (ng.h/mL)
PF-06882961 120mg QDAUC24 and AUCtau of PF-06882961 on Day 1, Day 14 or 21 and Day 28AUCtau1 on Day 28NA nanogram.hours/milliliter (ng.h/mL)
PF-06882961 120mg QDAUC24 and AUCtau of PF-06882961 on Day 1, Day 14 or 21 and Day 28AUC24 on Day 1184.6 nanogram.hours/milliliter (ng.h/mL)Geometric Coefficient of Variation 49
PF-06882961 120mg QDAUC24 and AUCtau of PF-06882961 on Day 1, Day 14 or 21 and Day 28AUCtau1 on Day 14 or 21NA nanogram.hours/milliliter (ng.h/mL)
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.

Time frame: 0, 1, 2, 4, 6, 8, 10, 12, 14 and 24 hours post dose on Day 1, 14 or 21, and 28

Population: All randomized participants treated who had at least 1 measurable concentration value.

ArmMeasureGroupValue (GEOMETRIC_MEAN)Dispersion
PlaceboMaximum Plasma Concentration (Cmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28Cmax1 on Day 2850.24 nanogram/milliliter (ng/mL)Geometric Coefficient of Variation 44
PlaceboMaximum Plasma Concentration (Cmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28Cmax on Day 14 or 2165.78 nanogram/milliliter (ng/mL)Geometric Coefficient of Variation 35
PlaceboMaximum Plasma Concentration (Cmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28Cmax on Day 2881.56 nanogram/milliliter (ng/mL)Geometric Coefficient of Variation 32
PlaceboMaximum Plasma Concentration (Cmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28Cmax2 on Day 14 or 2163.89 nanogram/milliliter (ng/mL)Geometric Coefficient of Variation 36
PlaceboMaximum Plasma Concentration (Cmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28Cmax2 on Day 2874.22 nanogram/milliliter (ng/mL)Geometric Coefficient of Variation 37
PlaceboMaximum Plasma Concentration (Cmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28Cmax1 on Day 142.69 nanogram/milliliter (ng/mL)Geometric Coefficient of Variation 29
PlaceboMaximum Plasma Concentration (Cmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28Cmax1 on Day 14 or 2155.00 nanogram/milliliter (ng/mL)Geometric Coefficient of Variation 43
PlaceboMaximum Plasma Concentration (Cmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28Cmax2 on Day 140.63 nanogram/milliliter (ng/mL)Geometric Coefficient of Variation 66
PlaceboMaximum Plasma Concentration (Cmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28Cmax on Day 150.58 nanogram/milliliter (ng/mL)Geometric Coefficient of Variation 40
PF-06882961 10mg BIDMaximum Plasma Concentration (Cmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28Cmax2 on Day 168.77 nanogram/milliliter (ng/mL)Geometric Coefficient of Variation 51
PF-06882961 10mg BIDMaximum Plasma Concentration (Cmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28Cmax on Day 1124.4 nanogram/milliliter (ng/mL)Geometric Coefficient of Variation 51
PF-06882961 10mg BIDMaximum Plasma Concentration (Cmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28Cmax on Day 14 or 21149.8 nanogram/milliliter (ng/mL)Geometric Coefficient of Variation 88
PF-06882961 10mg BIDMaximum Plasma Concentration (Cmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28Cmax1 on Day 28103.8 nanogram/milliliter (ng/mL)Geometric Coefficient of Variation 50
PF-06882961 10mg BIDMaximum Plasma Concentration (Cmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28Cmax1 on Day 14 or 21130.2 nanogram/milliliter (ng/mL)Geometric Coefficient of Variation 85
PF-06882961 10mg BIDMaximum Plasma Concentration (Cmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28Cmax2 on Day 28117.2 nanogram/milliliter (ng/mL)Geometric Coefficient of Variation 63
PF-06882961 10mg BIDMaximum Plasma Concentration (Cmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28Cmax1 on Day 1119.1 nanogram/milliliter (ng/mL)Geometric Coefficient of Variation 56
PF-06882961 10mg BIDMaximum Plasma Concentration (Cmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28Cmax2 on Day 14 or 21127.9 nanogram/milliliter (ng/mL)Geometric Coefficient of Variation 86
PF-06882961 10mg BIDMaximum Plasma Concentration (Cmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28Cmax on Day 28133.7 nanogram/milliliter (ng/mL)Geometric Coefficient of Variation 69
PF-06882961 15mg BIDMaximum Plasma Concentration (Cmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28Cmax2 on Day 142.33 nanogram/milliliter (ng/mL)Geometric Coefficient of Variation 59
PF-06882961 15mg BIDMaximum Plasma Concentration (Cmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28Cmax2 on Day 14 or 21202.8 nanogram/milliliter (ng/mL)Geometric Coefficient of Variation 50
PF-06882961 15mg BIDMaximum Plasma Concentration (Cmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28Cmax2 on Day 28306.5 nanogram/milliliter (ng/mL)Geometric Coefficient of Variation 49
PF-06882961 15mg BIDMaximum Plasma Concentration (Cmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28Cmax1 on Day 145.01 nanogram/milliliter (ng/mL)Geometric Coefficient of Variation 48
PF-06882961 15mg BIDMaximum Plasma Concentration (Cmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28Cmax on Day 149.75 nanogram/milliliter (ng/mL)Geometric Coefficient of Variation 50
PF-06882961 15mg BIDMaximum Plasma Concentration (Cmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28Cmax1 on Day 28197.9 nanogram/milliliter (ng/mL)Geometric Coefficient of Variation 51
PF-06882961 15mg BIDMaximum Plasma Concentration (Cmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28Cmax on Day 14 or 21253.6 nanogram/milliliter (ng/mL)Geometric Coefficient of Variation 76
PF-06882961 15mg BIDMaximum Plasma Concentration (Cmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28Cmax on Day 28328.8 nanogram/milliliter (ng/mL)Geometric Coefficient of Variation 49
PF-06882961 15mg BIDMaximum Plasma Concentration (Cmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28Cmax1 on Day 14 or 21235.1 nanogram/milliliter (ng/mL)Geometric Coefficient of Variation 84
PF-06882961 50mg BIDMaximum Plasma Concentration (Cmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28Cmax on Day 14 or 21788.4 nanogram/milliliter (ng/mL)Geometric Coefficient of Variation 89
PF-06882961 50mg BIDMaximum Plasma Concentration (Cmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28Cmax2 on Day 144.97 nanogram/milliliter (ng/mL)Geometric Coefficient of Variation 61
PF-06882961 50mg BIDMaximum Plasma Concentration (Cmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28Cmax1 on Day 14 or 21682.7 nanogram/milliliter (ng/mL)Geometric Coefficient of Variation 92
PF-06882961 50mg BIDMaximum Plasma Concentration (Cmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28Cmax1 on Day 28649.2 nanogram/milliliter (ng/mL)Geometric Coefficient of Variation 90
PF-06882961 50mg BIDMaximum Plasma Concentration (Cmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28Cmax1 on Day 136.51 nanogram/milliliter (ng/mL)Geometric Coefficient of Variation 43
PF-06882961 50mg BIDMaximum Plasma Concentration (Cmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28Cmax2 on Day 28617.9 nanogram/milliliter (ng/mL)Geometric Coefficient of Variation 93
PF-06882961 50mg BIDMaximum Plasma Concentration (Cmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28Cmax on Day 28685.2 nanogram/milliliter (ng/mL)Geometric Coefficient of Variation 87
PF-06882961 50mg BIDMaximum Plasma Concentration (Cmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28Cmax on Day 151.61 nanogram/milliliter (ng/mL)Geometric Coefficient of Variation 50
PF-06882961 50mg BIDMaximum Plasma Concentration (Cmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28Cmax2 on Day 14 or 21505.3 nanogram/milliliter (ng/mL)Geometric Coefficient of Variation 93
PF-06882961 70mg BIDMaximum Plasma Concentration (Cmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28Cmax1 on Day 14 or 2115.31 nanogram/milliliter (ng/mL)Geometric Coefficient of Variation 50
PF-06882961 70mg BIDMaximum Plasma Concentration (Cmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28Cmax on Day 115.02 nanogram/milliliter (ng/mL)Geometric Coefficient of Variation 70
PF-06882961 70mg BIDMaximum Plasma Concentration (Cmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28Cmax1 on Day 112.82 nanogram/milliliter (ng/mL)Geometric Coefficient of Variation 58
PF-06882961 70mg BIDMaximum Plasma Concentration (Cmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28Cmax2 on Day 113.98 nanogram/milliliter (ng/mL)Geometric Coefficient of Variation 75
PF-06882961 70mg BIDMaximum Plasma Concentration (Cmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28Cmax on Day 14 or 2118.63 nanogram/milliliter (ng/mL)Geometric Coefficient of Variation 47
PF-06882961 70mg BIDMaximum Plasma Concentration (Cmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28Cmax2 on Day 14 or 2117.16 nanogram/milliliter (ng/mL)Geometric Coefficient of Variation 58
PF-06882961 70mg BIDMaximum Plasma Concentration (Cmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28Cmax on Day 2838.38 nanogram/milliliter (ng/mL)Geometric Coefficient of Variation 58
PF-06882961 70mg BIDMaximum Plasma Concentration (Cmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28Cmax1 on Day 2830.42 nanogram/milliliter (ng/mL)Geometric Coefficient of Variation 52
PF-06882961 70mg BIDMaximum Plasma Concentration (Cmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28Cmax2 on Day 2835.01 nanogram/milliliter (ng/mL)Geometric Coefficient of Variation 56
PF-06882961 120mg BIDMaximum Plasma Concentration (Cmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28Cmax1 on Day 124.06 nanogram/milliliter (ng/mL)Geometric Coefficient of Variation 42
PF-06882961 120mg BIDMaximum Plasma Concentration (Cmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28Cmax on Day 126.02 nanogram/milliliter (ng/mL)Geometric Coefficient of Variation 39
PF-06882961 120mg BIDMaximum Plasma Concentration (Cmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28Cmax on Day 28437.6 nanogram/milliliter (ng/mL)Geometric Coefficient of Variation 94
PF-06882961 120mg BIDMaximum Plasma Concentration (Cmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28Cmax2 on Day 121.64 nanogram/milliliter (ng/mL)Geometric Coefficient of Variation 41
PF-06882961 120mg BIDMaximum Plasma Concentration (Cmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28Cmax on Day 14 or 21188.5 nanogram/milliliter (ng/mL)Geometric Coefficient of Variation 57
PF-06882961 120mg BIDMaximum Plasma Concentration (Cmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28Cmax2 on Day 28410.3 nanogram/milliliter (ng/mL)Geometric Coefficient of Variation 90
PF-06882961 120mg BIDMaximum Plasma Concentration (Cmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28Cmax1 on Day 14 or 21143.0 nanogram/milliliter (ng/mL)Geometric Coefficient of Variation 71
PF-06882961 120mg BIDMaximum Plasma Concentration (Cmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28Cmax1 on Day 28357.1 nanogram/milliliter (ng/mL)Geometric Coefficient of Variation 84
PF-06882961 120mg BIDMaximum Plasma Concentration (Cmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28Cmax2 on Day 14 or 21178.4 nanogram/milliliter (ng/mL)Geometric Coefficient of Variation 56
PF-06882961 120mg BID STMaximum Plasma Concentration (Cmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28Cmax1 on Day 28NA nanogram/milliliter (ng/mL)
PF-06882961 120mg BID STMaximum Plasma Concentration (Cmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28Cmax on Day 128.67 nanogram/milliliter (ng/mL)Geometric Coefficient of Variation 87
PF-06882961 120mg BID STMaximum Plasma Concentration (Cmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28Cmax1 on Day 14 or 21NA nanogram/milliliter (ng/mL)
PF-06882961 120mg BID STMaximum Plasma Concentration (Cmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28Cmax on Day 28303.9 nanogram/milliliter (ng/mL)Geometric Coefficient of Variation 32
PF-06882961 120mg BID STMaximum Plasma Concentration (Cmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28Cmax on Day 14 or 2198.11 nanogram/milliliter (ng/mL)Geometric Coefficient of Variation 54
PF-06882961 120mg BID STMaximum Plasma Concentration (Cmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28Cmax2 on Day 1NA nanogram/milliliter (ng/mL)
PF-06882961 120mg BID STMaximum Plasma Concentration (Cmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28Cmax1 on Day 1NA nanogram/milliliter (ng/mL)
PF-06882961 120mg BID STMaximum Plasma Concentration (Cmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28Cmax2 on Day 28NA nanogram/milliliter (ng/mL)
PF-06882961 120mg BID STMaximum Plasma Concentration (Cmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28Cmax2 on Day 14 or 21NA nanogram/milliliter (ng/mL)
PF-06882961 120mg QDMaximum Plasma Concentration (Cmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28Cmax2 on Day 28NA nanogram/milliliter (ng/mL)
PF-06882961 120mg QDMaximum Plasma Concentration (Cmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28Cmax2 on Day 14 or 21NA nanogram/milliliter (ng/mL)
PF-06882961 120mg QDMaximum Plasma Concentration (Cmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28Cmax on Day 14 or 21100.7 nanogram/milliliter (ng/mL)Geometric Coefficient of Variation 35
PF-06882961 120mg QDMaximum Plasma Concentration (Cmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28Cmax2 on Day 1NA nanogram/milliliter (ng/mL)
PF-06882961 120mg QDMaximum Plasma Concentration (Cmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28Cmax on Day 28192.2 nanogram/milliliter (ng/mL)Geometric Coefficient of Variation 52
PF-06882961 120mg QDMaximum Plasma Concentration (Cmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28Cmax1 on Day 1NA nanogram/milliliter (ng/mL)
PF-06882961 120mg QDMaximum Plasma Concentration (Cmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28Cmax1 on Day 28NA nanogram/milliliter (ng/mL)
PF-06882961 120mg QDMaximum Plasma Concentration (Cmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28Cmax on Day 120.40 nanogram/milliliter (ng/mL)Geometric Coefficient of Variation 29
PF-06882961 120mg QDMaximum Plasma Concentration (Cmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28Cmax1 on Day 14 or 21NA nanogram/milliliter (ng/mL)
Secondary

Renal Clearance (CLr) of PF-06882961 on Day 28

CLr was calculated as Ae divided by AUCtau, where dosing interval is 24 hours.

Time frame: 0 to 24 hours post-dose on Day 28

Population: All randomized participants who received at least 1 dose of PF-06882961 and who have at least 1 of the PK parameters of interest.

ArmMeasureValue (GEOMETRIC_MEAN)Dispersion
PlaceboRenal Clearance (CLr) of PF-06882961 on Day 280.3273 mL/minGeometric Coefficient of Variation 18
PF-06882961 10mg BIDRenal Clearance (CLr) of PF-06882961 on Day 280.3385 mL/minGeometric Coefficient of Variation 18
PF-06882961 15mg BIDRenal Clearance (CLr) of PF-06882961 on Day 280.3094 mL/minGeometric Coefficient of Variation 70
PF-06882961 50mg BIDRenal Clearance (CLr) of PF-06882961 on Day 28NA mL/min
PF-06882961 70mg BIDRenal Clearance (CLr) of PF-06882961 on Day 280.5470 mL/minGeometric Coefficient of Variation 26
PF-06882961 120mg BIDRenal Clearance (CLr) of PF-06882961 on Day 280.2006 mL/minGeometric Coefficient of Variation 228
PF-06882961 120mg BID STRenal Clearance (CLr) of PF-06882961 on Day 280.2895 mL/minGeometric Coefficient of Variation 21
PF-06882961 120mg QDRenal Clearance (CLr) of PF-06882961 on Day 280.3178 mL/minGeometric Coefficient of Variation 73
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.

Time frame: 0, 1, 2, 4, 6, 8, 10, 12, 14 and 24 hrs post dose on Day 28

Population: All participants randomized and treated who had at least 1 of the PK parameters of interest.

ArmMeasureValue (MEAN)Dispersion
PlaceboTerminal Half-life (t½) of PF-06882961 on Day 285.100 hoursStandard Deviation 1.2186
PF-06882961 10mg BIDTerminal Half-life (t½) of PF-06882961 on Day 285.067 hoursStandard Deviation 0.75593
PF-06882961 15mg BIDTerminal Half-life (t½) of PF-06882961 on Day 284.681 hoursStandard Deviation 0.59504
PF-06882961 50mg BIDTerminal Half-life (t½) of PF-06882961 on Day 286.203 hoursStandard Deviation 2.3505
PF-06882961 70mg BIDTerminal Half-life (t½) of PF-06882961 on Day 288.090 hoursStandard Deviation 3.3234
PF-06882961 120mg BIDTerminal Half-life (t½) of PF-06882961 on Day 286.730 hoursStandard Deviation 2.5056
PF-06882961 120mg BID STTerminal Half-life (t½) of PF-06882961 on Day 285.773 hoursStandard Deviation 1.4876
PF-06882961 120mg QDTerminal Half-life (t½) of PF-06882961 on Day 284.954 hoursStandard Deviation 0.58819
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.

Time frame: 0, 1, 2, 4, 6, 8, 10, 12, 14 and 24 hrs post dose on Day 1, 14 or 21, and 28

Population: All participants randomized and treated who had at least 1 of the PK parameters of interest.

ArmMeasureGroupValue (MEDIAN)
PlaceboTime for Cmax (Tmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28Tmax on Day 28NA hours
PlaceboTime for Cmax (Tmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28Tmax2 on Day 2812.0 hours
PlaceboTime for Cmax (Tmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28Tmax2 on Day 114.0 hours
PlaceboTime for Cmax (Tmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28Tmax1 on Day 285.00 hours
PlaceboTime for Cmax (Tmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28Tmax2 on Day 14 or 2113.0 hours
PlaceboTime for Cmax (Tmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28Tmax on Day 1NA hours
PlaceboTime for Cmax (Tmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28Tmax1 on Day 14 or 214.00 hours
PlaceboTime for Cmax (Tmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28Tmax on Day 14 or 21NA hours
PlaceboTime for Cmax (Tmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28Tmax1 on Day 14.00 hours
PF-06882961 10mg BIDTime for Cmax (Tmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28Tmax on Day 1NA hours
PF-06882961 10mg BIDTime for Cmax (Tmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28Tmax on Day 28NA hours
PF-06882961 10mg BIDTime for Cmax (Tmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28Tmax1 on Day 14.00 hours
PF-06882961 10mg BIDTime for Cmax (Tmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28Tmax2 on Day 2812.0 hours
PF-06882961 10mg BIDTime for Cmax (Tmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28Tmax2 on Day 114.0 hours
PF-06882961 10mg BIDTime for Cmax (Tmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28Tmax on Day 14 or 21NA hours
PF-06882961 10mg BIDTime for Cmax (Tmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28Tmax1 on Day 14 or 214.00 hours
PF-06882961 10mg BIDTime for Cmax (Tmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28Tmax1 on Day 283.00 hours
PF-06882961 10mg BIDTime for Cmax (Tmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28Tmax2 on Day 14 or 2113.0 hours
PF-06882961 15mg BIDTime for Cmax (Tmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28Tmax2 on Day 14 or 2112.0 hours
PF-06882961 15mg BIDTime for Cmax (Tmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28Tmax on Day 14 or 21NA hours
PF-06882961 15mg BIDTime for Cmax (Tmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28Tmax1 on Day 12.00 hours
PF-06882961 15mg BIDTime for Cmax (Tmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28Tmax on Day 1NA hours
PF-06882961 15mg BIDTime for Cmax (Tmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28Tmax2 on Day 2812.0 hours
PF-06882961 15mg BIDTime for Cmax (Tmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28Tmax on Day 28NA hours
PF-06882961 15mg BIDTime for Cmax (Tmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28Tmax1 on Day 14 or 211.05 hours
PF-06882961 15mg BIDTime for Cmax (Tmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28Tmax1 on Day 286.00 hours
PF-06882961 15mg BIDTime for Cmax (Tmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28Tmax2 on Day 114.0 hours
PF-06882961 50mg BIDTime for Cmax (Tmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28Tmax2 on Day 2812.0 hours
PF-06882961 50mg BIDTime for Cmax (Tmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28Tmax1 on Day 14.00 hours
PF-06882961 50mg BIDTime for Cmax (Tmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28Tmax on Day 14 or 21NA hours
PF-06882961 50mg BIDTime for Cmax (Tmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28Tmax on Day 1NA hours
PF-06882961 50mg BIDTime for Cmax (Tmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28Tmax1 on Day 284.00 hours
PF-06882961 50mg BIDTime for Cmax (Tmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28Tmax2 on Day 114.0 hours
PF-06882961 50mg BIDTime for Cmax (Tmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28Tmax2 on Day 14 or 2112.0 hours
PF-06882961 50mg BIDTime for Cmax (Tmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28Tmax1 on Day 14 or 211.54 hours
PF-06882961 50mg BIDTime for Cmax (Tmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28Tmax on Day 28NA hours
PF-06882961 70mg BIDTime for Cmax (Tmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28Tmax on Day 28NA hours
PF-06882961 70mg BIDTime for Cmax (Tmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28Tmax2 on Day 112.0 hours
PF-06882961 70mg BIDTime for Cmax (Tmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28Tmax1 on Day 284.00 hours
PF-06882961 70mg BIDTime for Cmax (Tmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28Tmax on Day 14 or 21NA hours
PF-06882961 70mg BIDTime for Cmax (Tmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28Tmax on Day 1NA hours
PF-06882961 70mg BIDTime for Cmax (Tmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28Tmax2 on Day 2812.0 hours
PF-06882961 70mg BIDTime for Cmax (Tmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28Tmax1 on Day 14 or 216.00 hours
PF-06882961 70mg BIDTime for Cmax (Tmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28Tmax2 on Day 14 or 2112.0 hours
PF-06882961 70mg BIDTime for Cmax (Tmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28Tmax1 on Day 12.00 hours
PF-06882961 120mg BIDTime for Cmax (Tmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28Tmax1 on Day 14 or 216.00 hours
PF-06882961 120mg BIDTime for Cmax (Tmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28Tmax on Day 1NA hours
PF-06882961 120mg BIDTime for Cmax (Tmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28Tmax1 on Day 12.00 hours
PF-06882961 120mg BIDTime for Cmax (Tmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28Tmax2 on Day 114.0 hours
PF-06882961 120mg BIDTime for Cmax (Tmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28Tmax on Day 14 or 21NA hours
PF-06882961 120mg BIDTime for Cmax (Tmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28Tmax2 on Day 14 or 2114.0 hours
PF-06882961 120mg BIDTime for Cmax (Tmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28Tmax on Day 28NA hours
PF-06882961 120mg BIDTime for Cmax (Tmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28Tmax1 on Day 286.00 hours
PF-06882961 120mg BIDTime for Cmax (Tmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28Tmax2 on Day 2812.0 hours
PF-06882961 120mg BID STTime for Cmax (Tmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28Tmax on Day 2814.0 hours
PF-06882961 120mg BID STTime for Cmax (Tmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28Tmax2 on Day 14 or 21NA hours
PF-06882961 120mg BID STTime for Cmax (Tmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28Tmax1 on Day 14 or 21NA hours
PF-06882961 120mg BID STTime for Cmax (Tmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28Tmax on Day 14 or 2112.0 hours
PF-06882961 120mg BID STTime for Cmax (Tmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28Tmax1 on Day 28NA hours
PF-06882961 120mg BID STTime for Cmax (Tmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28Tmax2 on Day 1NA hours
PF-06882961 120mg BID STTime for Cmax (Tmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28Tmax1 on Day 1NA hours
PF-06882961 120mg BID STTime for Cmax (Tmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28Tmax on Day 113.0 hours
PF-06882961 120mg BID STTime for Cmax (Tmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28Tmax2 on Day 28NA hours
PF-06882961 120mg QDTime for Cmax (Tmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28Tmax on Day 14 or 216.00 hours
PF-06882961 120mg QDTime for Cmax (Tmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28Tmax1 on Day 1NA hours
PF-06882961 120mg QDTime for Cmax (Tmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28Tmax1 on Day 14 or 21NA hours
PF-06882961 120mg QDTime for Cmax (Tmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28Tmax2 on Day 14 or 21NA hours
PF-06882961 120mg QDTime for Cmax (Tmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28Tmax on Day 13.00 hours
PF-06882961 120mg QDTime for Cmax (Tmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28Tmax2 on Day 1NA hours
PF-06882961 120mg QDTime for Cmax (Tmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28Tmax2 on Day 28NA hours
PF-06882961 120mg QDTime for Cmax (Tmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28Tmax on Day 2810.0 hours
PF-06882961 120mg QDTime for Cmax (Tmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28Tmax1 on Day 28NA hours

Source: ClinicalTrials.gov · Data processed: Feb 22, 2026