Type 2 Diabetes Mellitus
Conditions
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
Tablet, 0 mg, twice daily, 28 days
Tablet, 15 mg twice daily, 28 days
Sponsors
Study design
Eligibility
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
| Measure | Time frame | Description |
|---|---|---|
| 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 days | 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. |
| 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 | 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). |
| Number of Participants With Abnormal Vital Signs | From baseline to up to 14 days after last dose for a total of approximately 42 days | 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. |
| Number of Participants With Abnormal Electrocardiogram (ECG) Interval | From baseline to up to 14 days after last dose for a total of approximately 42 days | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Amount of Unchanged Drug Recovered in Urine Over 24 Hours (Ae24) of PF-06882961 on Day 28 | 0 to 24 hours post-dose 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. |
| AUC24 and AUCtau of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | 0, 1, 2, 4, 6, 8, 10, 12, 14 and 24 hrs post dose on Day 1, 14 or 21, and 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. |
| Renal Clearance (CLr) of PF-06882961 on Day 28 | 0 to 24 hours post-dose on Day 28 | CLr was calculated as Ae divided by AUCtau, where dosing interval is 24 hours. |
| Ae24 (%) of PF-06882961 on Day 28 | 0 to 24 hours post-dose on Day 28 | Percent 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 28 | 0, 1, 2, 4, 6, 8, 10, 12, 14 and 24 hours post dose on Day 1, 14 or 21, and 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 for Cmax (Tmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | 0, 1, 2, 4, 6, 8, 10, 12, 14 and 24 hrs post dose on Day 1, 14 or 21, and 28 | Time 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 28 | 0, 1, 2, 4, 6, 8, 10, 12, 14 and 24 hrs post dose on Day 28 | Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 |
| Total | 98 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 |
|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 0 | 1 | 1 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Non-Treatment-Related Reasons | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 3 |
| Overall Study | Withdrawal by Subject | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | PF-06882961 10mg BID | PF-06882961 15mg BID | PF-06882961 50mg BID | PF-06882961 70mg BID | PF-06882961 120mg BID | PF-06882961 120mg BID ST | PF-06882961 120mg QD | Placebo | PF-06882961 200mg QD CR | Total |
|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized 18-44 years | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 4 Participants |
| Age, Customized 45-64 years | 8 Participants | 6 Participants | 6 Participants | 8 Participants | 8 Participants | 7 Participants | 7 Participants | 19 Participants | 8 Participants | 77 Participants |
| Age, Customized >=65 years | 0 Participants | 2 Participants | 4 Participants | 1 Participants | 0 Participants | 2 Participants | 1 Participants | 5 Participants | 2 Participants | 17 Participants |
| Age Range | 55.0 Years | 55.0 Years | 63.5 Years | 60.0 Years | 57.0 Years | 58.0 Years | 58.0 Years | 60.0 Years | 59.0 Years | 58.0 Years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants | 4 Participants | 7 Participants | 6 Participants | 4 Participants | 4 Participants | 6 Participants | 18 Participants | 6 Participants | 61 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 3 Participants | 5 Participants | 3 Participants | 3 Participants | 5 Participants | 5 Participants | 2 Participants | 7 Participants | 4 Participants | 37 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Black or African American | 2 Participants | 3 Participants | 2 Participants | 2 Participants | 3 Participants | 5 Participants | 0 Participants | 7 Participants | 3 Participants | 27 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized White | 7 Participants | 5 Participants | 8 Participants | 7 Participants | 6 Participants | 4 Participants | 8 Participants | 18 Participants | 7 Participants | 70 Participants |
| Sex: Female, Male Female | 2 Participants | 6 Participants | 5 Participants | 5 Participants | 2 Participants | 5 Participants | 4 Participants | 13 Participants | 5 Participants | 47 Participants |
| Sex: Female, Male Male | 7 Participants | 3 Participants | 5 Participants | 4 Participants | 7 Participants | 4 Participants | 4 Participants | 12 Participants | 5 Participants | 51 Participants |
Adverse events
| Event type | EG000 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 / 25 | 0 / 9 | 0 / 9 | 0 / 10 | 0 / 9 | 0 / 9 | 0 / 9 | 0 / 8 | 0 / 10 |
| other Total, other adverse events | 15 / 25 | 6 / 9 | 8 / 9 | 10 / 10 | 8 / 9 | 8 / 9 | 9 / 9 | 8 / 8 | 9 / 10 |
| serious Total, serious adverse events | 0 / 25 | 0 / 9 | 0 / 9 | 0 / 10 | 0 / 9 | 0 / 9 | 1 / 9 | 0 / 8 | 0 / 10 |
Outcome results
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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With Abnormal Electrocardiogram (ECG) Interval | QTcF interval >450 and ≤480 msec | 2 Participants |
| Placebo | Number of Participants With Abnormal Electrocardiogram (ECG) Interval | Change in QTcF interval >30 and ≤60 msec | 0 Participants |
| Placebo | Number of Participants With Abnormal Electrocardiogram (ECG) Interval | %Change in QRS duration ≥50% | 0 Participants |
| Placebo | Number of Participants With Abnormal Electrocardiogram (ECG) Interval | QTcF interval >500 msec | 0 Participants |
| Placebo | Number of Participants With Abnormal Electrocardiogram (ECG) Interval | Change in QTcF interval >60 msec | 0 Participants |
| Placebo | Number of Participants With Abnormal Electrocardiogram (ECG) Interval | QTcF interval >480 and ≤500 msec | 0 Participants |
| Placebo | Number of Participants With Abnormal Electrocardiogram (ECG) Interval | QRS duration ≥140 msec | 0 Participants |
| Placebo | Number of Participants With Abnormal Electrocardiogram (ECG) Interval | %Change in PR interval ≥25/50% | 0 Participants |
| Placebo | Number of Participants With Abnormal Electrocardiogram (ECG) Interval | PR interval ≥300 msec | 0 Participants |
| PF-06882961 10mg BID | Number of Participants With Abnormal Electrocardiogram (ECG) Interval | QTcF interval >450 and ≤480 msec | 0 Participants |
| PF-06882961 10mg BID | Number of Participants With Abnormal Electrocardiogram (ECG) Interval | PR interval ≥300 msec | 0 Participants |
| PF-06882961 10mg BID | Number of Participants With Abnormal Electrocardiogram (ECG) Interval | Change in QTcF interval >30 and ≤60 msec | 1 Participants |
| PF-06882961 10mg BID | Number of Participants With Abnormal Electrocardiogram (ECG) Interval | %Change in PR interval ≥25/50% | 0 Participants |
| PF-06882961 10mg BID | Number of Participants With Abnormal Electrocardiogram (ECG) Interval | QRS duration ≥140 msec | 0 Participants |
| PF-06882961 10mg BID | Number of Participants With Abnormal Electrocardiogram (ECG) Interval | QTcF interval >500 msec | 0 Participants |
| PF-06882961 10mg BID | Number of Participants With Abnormal Electrocardiogram (ECG) Interval | %Change in QRS duration ≥50% | 0 Participants |
| PF-06882961 10mg BID | Number of Participants With Abnormal Electrocardiogram (ECG) Interval | Change in QTcF interval >60 msec | 0 Participants |
| PF-06882961 10mg BID | Number of Participants With Abnormal Electrocardiogram (ECG) Interval | QTcF interval >480 and ≤500 msec | 0 Participants |
| PF-06882961 15mg BID | Number of Participants With Abnormal Electrocardiogram (ECG) Interval | QTcF interval >450 and ≤480 msec | 1 Participants |
| PF-06882961 15mg BID | Number of Participants With Abnormal Electrocardiogram (ECG) Interval | QRS duration ≥140 msec | 0 Participants |
| PF-06882961 15mg BID | Number of Participants With Abnormal Electrocardiogram (ECG) Interval | PR interval ≥300 msec | 0 Participants |
| PF-06882961 15mg BID | Number of Participants With Abnormal Electrocardiogram (ECG) Interval | Change in QTcF interval >60 msec | 0 Participants |
| PF-06882961 15mg BID | Number of Participants With Abnormal Electrocardiogram (ECG) Interval | Change in QTcF interval >30 and ≤60 msec | 0 Participants |
| PF-06882961 15mg BID | Number of Participants With Abnormal Electrocardiogram (ECG) Interval | %Change in QRS duration ≥50% | 0 Participants |
| PF-06882961 15mg BID | Number of Participants With Abnormal Electrocardiogram (ECG) Interval | %Change in PR interval ≥25/50% | 0 Participants |
| PF-06882961 15mg BID | Number of Participants With Abnormal Electrocardiogram (ECG) Interval | QTcF interval >500 msec | 0 Participants |
| PF-06882961 15mg BID | Number of Participants With Abnormal Electrocardiogram (ECG) Interval | QTcF interval >480 and ≤500 msec | 0 Participants |
| PF-06882961 50mg BID | Number of Participants With Abnormal Electrocardiogram (ECG) Interval | Change in QTcF interval >30 and ≤60 msec | 0 Participants |
| PF-06882961 50mg BID | Number of Participants With Abnormal Electrocardiogram (ECG) Interval | %Change in PR interval ≥25/50% | 0 Participants |
| PF-06882961 50mg BID | Number of Participants With Abnormal Electrocardiogram (ECG) Interval | QTcF interval >500 msec | 0 Participants |
| PF-06882961 50mg BID | Number of Participants With Abnormal Electrocardiogram (ECG) Interval | QRS duration ≥140 msec | 0 Participants |
| PF-06882961 50mg BID | Number of Participants With Abnormal Electrocardiogram (ECG) Interval | QTcF interval >480 and ≤500 msec | 0 Participants |
| PF-06882961 50mg BID | Number of Participants With Abnormal Electrocardiogram (ECG) Interval | QTcF interval >450 and ≤480 msec | 0 Participants |
| PF-06882961 50mg BID | Number of Participants With Abnormal Electrocardiogram (ECG) Interval | PR interval ≥300 msec | 0 Participants |
| PF-06882961 50mg BID | Number of Participants With Abnormal Electrocardiogram (ECG) Interval | Change in QTcF interval >60 msec | 0 Participants |
| PF-06882961 50mg BID | Number of Participants With Abnormal Electrocardiogram (ECG) Interval | %Change in QRS duration ≥50% | 0 Participants |
| PF-06882961 70mg BID | Number of Participants With Abnormal Electrocardiogram (ECG) Interval | Change in QTcF interval >30 and ≤60 msec | 0 Participants |
| PF-06882961 70mg BID | Number of Participants With Abnormal Electrocardiogram (ECG) Interval | QTcF interval >500 msec | 0 Participants |
| PF-06882961 70mg BID | Number of Participants With Abnormal Electrocardiogram (ECG) Interval | %Change in QRS duration ≥50% | 0 Participants |
| PF-06882961 70mg BID | Number of Participants With Abnormal Electrocardiogram (ECG) Interval | PR interval ≥300 msec | 0 Participants |
| PF-06882961 70mg BID | Number of Participants With Abnormal Electrocardiogram (ECG) Interval | QRS duration ≥140 msec | 0 Participants |
| PF-06882961 70mg BID | Number of Participants With Abnormal Electrocardiogram (ECG) Interval | %Change in PR interval ≥25/50% | 0 Participants |
| PF-06882961 70mg BID | Number of Participants With Abnormal Electrocardiogram (ECG) Interval | QTcF interval >450 and ≤480 msec | 0 Participants |
| PF-06882961 70mg BID | Number of Participants With Abnormal Electrocardiogram (ECG) Interval | QTcF interval >480 and ≤500 msec | 0 Participants |
| PF-06882961 70mg BID | Number of Participants With Abnormal Electrocardiogram (ECG) Interval | Change in QTcF interval >60 msec | 0 Participants |
| PF-06882961 120mg BID | Number of Participants With Abnormal Electrocardiogram (ECG) Interval | %Change in QRS duration ≥50% | 0 Participants |
| PF-06882961 120mg BID | Number of Participants With Abnormal Electrocardiogram (ECG) Interval | Change in QTcF interval >60 msec | 0 Participants |
| PF-06882961 120mg BID | Number of Participants With Abnormal Electrocardiogram (ECG) Interval | PR interval ≥300 msec | 0 Participants |
| PF-06882961 120mg BID | Number of Participants With Abnormal Electrocardiogram (ECG) Interval | %Change in PR interval ≥25/50% | 0 Participants |
| PF-06882961 120mg BID | Number of Participants With Abnormal Electrocardiogram (ECG) Interval | QRS duration ≥140 msec | 0 Participants |
| PF-06882961 120mg BID | Number of Participants With Abnormal Electrocardiogram (ECG) Interval | QTcF interval >450 and ≤480 msec | 0 Participants |
| PF-06882961 120mg BID | Number of Participants With Abnormal Electrocardiogram (ECG) Interval | QTcF interval >480 and ≤500 msec | 0 Participants |
| PF-06882961 120mg BID | Number of Participants With Abnormal Electrocardiogram (ECG) Interval | QTcF interval >500 msec | 0 Participants |
| PF-06882961 120mg BID | Number of Participants With Abnormal Electrocardiogram (ECG) Interval | Change in QTcF interval >30 and ≤60 msec | 1 Participants |
| PF-06882961 120mg BID ST | Number of Participants With Abnormal Electrocardiogram (ECG) Interval | QRS duration ≥140 msec | 0 Participants |
| PF-06882961 120mg BID ST | Number of Participants With Abnormal Electrocardiogram (ECG) Interval | Change in QTcF interval >60 msec | 0 Participants |
| PF-06882961 120mg BID ST | Number of Participants With Abnormal Electrocardiogram (ECG) Interval | Change in QTcF interval >30 and ≤60 msec | 0 Participants |
| PF-06882961 120mg BID ST | Number of Participants With Abnormal Electrocardiogram (ECG) Interval | %Change in PR interval ≥25/50% | 0 Participants |
| PF-06882961 120mg BID ST | Number of Participants With Abnormal Electrocardiogram (ECG) Interval | %Change in QRS duration ≥50% | 0 Participants |
| PF-06882961 120mg BID ST | Number of Participants With Abnormal Electrocardiogram (ECG) Interval | QTcF interval >500 msec | 0 Participants |
| PF-06882961 120mg BID ST | Number of Participants With Abnormal Electrocardiogram (ECG) Interval | PR interval ≥300 msec | 0 Participants |
| PF-06882961 120mg BID ST | Number of Participants With Abnormal Electrocardiogram (ECG) Interval | QTcF interval >480 and ≤500 msec | 0 Participants |
| PF-06882961 120mg BID ST | Number of Participants With Abnormal Electrocardiogram (ECG) Interval | QTcF interval >450 and ≤480 msec | 0 Participants |
| PF-06882961 120mg QD | Number of Participants With Abnormal Electrocardiogram (ECG) Interval | QTcF interval >480 and ≤500 msec | 0 Participants |
| PF-06882961 120mg QD | Number of Participants With Abnormal Electrocardiogram (ECG) Interval | Change in QTcF interval >60 msec | 0 Participants |
| PF-06882961 120mg QD | Number of Participants With Abnormal Electrocardiogram (ECG) Interval | QTcF interval >450 and ≤480 msec | 0 Participants |
| PF-06882961 120mg QD | Number of Participants With Abnormal Electrocardiogram (ECG) Interval | QRS duration ≥140 msec | 0 Participants |
| PF-06882961 120mg QD | Number of Participants With Abnormal Electrocardiogram (ECG) Interval | %Change in QRS duration ≥50% | 0 Participants |
| PF-06882961 120mg QD | Number of Participants With Abnormal Electrocardiogram (ECG) Interval | %Change in PR interval ≥25/50% | 0 Participants |
| PF-06882961 120mg QD | Number of Participants With Abnormal Electrocardiogram (ECG) Interval | Change in QTcF interval >30 and ≤60 msec | 0 Participants |
| PF-06882961 120mg QD | Number of Participants With Abnormal Electrocardiogram (ECG) Interval | QTcF interval >500 msec | 0 Participants |
| PF-06882961 120mg QD | Number of Participants With Abnormal Electrocardiogram (ECG) Interval | PR interval ≥300 msec | 0 Participants |
| PF-06882961 200mg QD CR | Number of Participants With Abnormal Electrocardiogram (ECG) Interval | Change in QTcF interval >30 and ≤60 msec | 0 Participants |
| PF-06882961 200mg QD CR | Number of Participants With Abnormal Electrocardiogram (ECG) Interval | QRS duration ≥140 msec | 0 Participants |
| PF-06882961 200mg QD CR | Number of Participants With Abnormal Electrocardiogram (ECG) Interval | QTcF interval >480 and ≤500 msec | 0 Participants |
| PF-06882961 200mg QD CR | Number of Participants With Abnormal Electrocardiogram (ECG) Interval | %Change in PR interval ≥25/50% | 0 Participants |
| PF-06882961 200mg QD CR | Number of Participants With Abnormal Electrocardiogram (ECG) Interval | %Change in QRS duration ≥50% | 0 Participants |
| PF-06882961 200mg QD CR | Number of Participants With Abnormal Electrocardiogram (ECG) Interval | QTcF interval >500 msec | 0 Participants |
| PF-06882961 200mg QD CR | Number of Participants With Abnormal Electrocardiogram (ECG) Interval | PR interval ≥300 msec | 0 Participants |
| PF-06882961 200mg QD CR | Number of Participants With Abnormal Electrocardiogram (ECG) Interval | Change in QTcF interval >60 msec | 0 Participants |
| PF-06882961 200mg QD CR | Number of Participants With Abnormal Electrocardiogram (ECG) Interval | QTcF interval >450 and ≤480 msec | 0 Participants |
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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With Abnormal Vital Signs | Supine pulse rate >120 bpm | 0 Participants |
| Placebo | Number of Participants With Abnormal Vital Signs | Supine SBP <90 mmHg | 3 Participants |
| Placebo | Number of Participants With Abnormal Vital Signs | Supine SBP increase >=30 mmHg | 4 Participants |
| Placebo | Number of Participants With Abnormal Vital Signs | Supine DBP <50 mmHg | 1 Participants |
| Placebo | Number of Participants With Abnormal Vital Signs | Supine SBP decrease >=30 mmHg | 9 Participants |
| Placebo | Number of Participants With Abnormal Vital Signs | Supine DBP decrease >=20 mmHg | 6 Participants |
| Placebo | Number of Participants With Abnormal Vital Signs | Supine DBP increase >=20 mmHg | 1 Participants |
| Placebo | Number of Participants With Abnormal Vital Signs | Supine pulse rate <40 bpm | 0 Participants |
| PF-06882961 10mg BID | Number of Participants With Abnormal Vital Signs | Supine DBP decrease >=20 mmHg | 2 Participants |
| PF-06882961 10mg BID | Number of Participants With Abnormal Vital Signs | Supine DBP increase >=20 mmHg | 1 Participants |
| PF-06882961 10mg BID | Number of Participants With Abnormal Vital Signs | Supine pulse rate <40 bpm | 0 Participants |
| PF-06882961 10mg BID | Number of Participants With Abnormal Vital Signs | Supine SBP increase >=30 mmHg | 0 Participants |
| PF-06882961 10mg BID | Number of Participants With Abnormal Vital Signs | Supine SBP <90 mmHg | 3 Participants |
| PF-06882961 10mg BID | Number of Participants With Abnormal Vital Signs | Supine SBP decrease >=30 mmHg | 2 Participants |
| PF-06882961 10mg BID | Number of Participants With Abnormal Vital Signs | Supine pulse rate >120 bpm | 0 Participants |
| PF-06882961 10mg BID | Number of Participants With Abnormal Vital Signs | Supine DBP <50 mmHg | 1 Participants |
| PF-06882961 15mg BID | Number of Participants With Abnormal Vital Signs | Supine DBP decrease >=20 mmHg | 1 Participants |
| PF-06882961 15mg BID | Number of Participants With Abnormal Vital Signs | Supine pulse rate <40 bpm | 0 Participants |
| PF-06882961 15mg BID | Number of Participants With Abnormal Vital Signs | Supine SBP decrease >=30 mmHg | 5 Participants |
| PF-06882961 15mg BID | Number of Participants With Abnormal Vital Signs | Supine pulse rate >120 bpm | 0 Participants |
| PF-06882961 15mg BID | Number of Participants With Abnormal Vital Signs | Supine DBP <50 mmHg | 2 Participants |
| PF-06882961 15mg BID | Number of Participants With Abnormal Vital Signs | Supine DBP increase >=20 mmHg | 1 Participants |
| PF-06882961 15mg BID | Number of Participants With Abnormal Vital Signs | Supine SBP <90 mmHg | 2 Participants |
| PF-06882961 15mg BID | Number of Participants With Abnormal Vital Signs | Supine SBP increase >=30 mmHg | 0 Participants |
| PF-06882961 50mg BID | Number of Participants With Abnormal Vital Signs | Supine DBP decrease >=20 mmHg | 2 Participants |
| PF-06882961 50mg BID | Number of Participants With Abnormal Vital Signs | Supine DBP increase >=20 mmHg | 0 Participants |
| PF-06882961 50mg BID | Number of Participants With Abnormal Vital Signs | Supine SBP <90 mmHg | 1 Participants |
| PF-06882961 50mg BID | Number of Participants With Abnormal Vital Signs | Supine pulse rate <40 bpm | 0 Participants |
| PF-06882961 50mg BID | Number of Participants With Abnormal Vital Signs | Supine DBP <50 mmHg | 1 Participants |
| PF-06882961 50mg BID | Number of Participants With Abnormal Vital Signs | Supine SBP increase >=30 mmHg | 2 Participants |
| PF-06882961 50mg BID | Number of Participants With Abnormal Vital Signs | Supine SBP decrease >=30 mmHg | 3 Participants |
| PF-06882961 50mg BID | Number of Participants With Abnormal Vital Signs | Supine pulse rate >120 bpm | 0 Participants |
| PF-06882961 70mg BID | Number of Participants With Abnormal Vital Signs | Supine DBP <50 mmHg | 1 Participants |
| PF-06882961 70mg BID | Number of Participants With Abnormal Vital Signs | Supine pulse rate >120 bpm | 0 Participants |
| PF-06882961 70mg BID | Number of Participants With Abnormal Vital Signs | Supine SBP increase >=30 mmHg | 3 Participants |
| PF-06882961 70mg BID | Number of Participants With Abnormal Vital Signs | Supine SBP decrease >=30 mmHg | 5 Participants |
| PF-06882961 70mg BID | Number of Participants With Abnormal Vital Signs | Supine DBP increase >=20 mmHg | 4 Participants |
| PF-06882961 70mg BID | Number of Participants With Abnormal Vital Signs | Supine DBP decrease >=20 mmHg | 1 Participants |
| PF-06882961 70mg BID | Number of Participants With Abnormal Vital Signs | Supine SBP <90 mmHg | 3 Participants |
| PF-06882961 70mg BID | Number of Participants With Abnormal Vital Signs | Supine pulse rate <40 bpm | 0 Participants |
| PF-06882961 120mg BID | Number of Participants With Abnormal Vital Signs | Supine SBP increase >=30 mmHg | 1 Participants |
| PF-06882961 120mg BID | Number of Participants With Abnormal Vital Signs | Supine pulse rate >120 bpm | 0 Participants |
| PF-06882961 120mg BID | Number of Participants With Abnormal Vital Signs | Supine pulse rate <40 bpm | 0 Participants |
| PF-06882961 120mg BID | Number of Participants With Abnormal Vital Signs | Supine DBP decrease >=20 mmHg | 3 Participants |
| PF-06882961 120mg BID | Number of Participants With Abnormal Vital Signs | Supine DBP <50 mmHg | 0 Participants |
| PF-06882961 120mg BID | Number of Participants With Abnormal Vital Signs | Supine SBP decrease >=30 mmHg | 3 Participants |
| PF-06882961 120mg BID | Number of Participants With Abnormal Vital Signs | Supine SBP <90 mmHg | 0 Participants |
| PF-06882961 120mg BID | Number of Participants With Abnormal Vital Signs | Supine DBP increase >=20 mmHg | 1 Participants |
| PF-06882961 120mg BID ST | Number of Participants With Abnormal Vital Signs | Supine SBP decrease >=30 mmHg | 3 Participants |
| PF-06882961 120mg BID ST | Number of Participants With Abnormal Vital Signs | Supine DBP increase >=20 mmHg | 2 Participants |
| PF-06882961 120mg BID ST | Number of Participants With Abnormal Vital Signs | Supine SBP increase >=30 mmHg | 2 Participants |
| PF-06882961 120mg BID ST | Number of Participants With Abnormal Vital Signs | Supine pulse rate <40 bpm | 0 Participants |
| PF-06882961 120mg BID ST | Number of Participants With Abnormal Vital Signs | Supine DBP decrease >=20 mmHg | 4 Participants |
| PF-06882961 120mg BID ST | Number of Participants With Abnormal Vital Signs | Supine SBP <90 mmHg | 3 Participants |
| PF-06882961 120mg BID ST | Number of Participants With Abnormal Vital Signs | Supine pulse rate >120 bpm | 0 Participants |
| PF-06882961 120mg BID ST | Number of Participants With Abnormal Vital Signs | Supine DBP <50 mmHg | 2 Participants |
| PF-06882961 120mg QD | Number of Participants With Abnormal Vital Signs | Supine pulse rate >120 bpm | 0 Participants |
| PF-06882961 120mg QD | Number of Participants With Abnormal Vital Signs | Supine DBP increase >=20 mmHg | 2 Participants |
| PF-06882961 120mg QD | Number of Participants With Abnormal Vital Signs | Supine SBP <90 mmHg | 0 Participants |
| PF-06882961 120mg QD | Number of Participants With Abnormal Vital Signs | Supine SBP increase >=30 mmHg | 2 Participants |
| PF-06882961 120mg QD | Number of Participants With Abnormal Vital Signs | Supine DBP <50 mmHg | 0 Participants |
| PF-06882961 120mg QD | Number of Participants With Abnormal Vital Signs | Supine DBP decrease >=20 mmHg | 2 Participants |
| PF-06882961 120mg QD | Number of Participants With Abnormal Vital Signs | Supine pulse rate <40 bpm | 0 Participants |
| PF-06882961 120mg QD | Number of Participants With Abnormal Vital Signs | Supine SBP decrease >=30 mmHg | 5 Participants |
| PF-06882961 200mg QD CR | Number of Participants With Abnormal Vital Signs | Supine DBP increase >=20 mmHg | 1 Participants |
| PF-06882961 200mg QD CR | Number of Participants With Abnormal Vital Signs | Supine SBP <90 mmHg | 1 Participants |
| PF-06882961 200mg QD CR | Number of Participants With Abnormal Vital Signs | Supine SBP increase >=30 mmHg | 1 Participants |
| PF-06882961 200mg QD CR | Number of Participants With Abnormal Vital Signs | Supine SBP decrease >=30 mmHg | 4 Participants |
| PF-06882961 200mg QD CR | Number of Participants With Abnormal Vital Signs | Supine DBP <50 mmHg | 0 Participants |
| PF-06882961 200mg QD CR | Number of Participants With Abnormal Vital Signs | Supine DBP decrease >=20 mmHg | 3 Participants |
| PF-06882961 200mg QD CR | Number of Participants With Abnormal Vital Signs | Supine pulse rate <40 bpm | 0 Participants |
| PF-06882961 200mg QD CR | Number of Participants With Abnormal Vital Signs | Supine pulse rate >120 bpm | 0 Participants |
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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With All-causality and Treatment-related Treatment-emergent Adverse Events (TEAEs) | All-causality AE | 17 Participants |
| Placebo | Number of Participants With All-causality and Treatment-related Treatment-emergent Adverse Events (TEAEs) | All-causality SAE | 0 Participants |
| Placebo | Number of Participants With All-causality and Treatment-related Treatment-emergent Adverse Events (TEAEs) | Treatment-related AE | 14 Participants |
| Placebo | Number of Participants With All-causality and Treatment-related Treatment-emergent Adverse Events (TEAEs) | Treatment-related SAE | 0 Participants |
| PF-06882961 10mg BID | Number of Participants With All-causality and Treatment-related Treatment-emergent Adverse Events (TEAEs) | Treatment-related SAE | 0 Participants |
| PF-06882961 10mg BID | Number of Participants With All-causality and Treatment-related Treatment-emergent Adverse Events (TEAEs) | All-causality AE | 6 Participants |
| PF-06882961 10mg BID | Number of Participants With All-causality and Treatment-related Treatment-emergent Adverse Events (TEAEs) | All-causality SAE | 0 Participants |
| PF-06882961 10mg BID | Number of Participants With All-causality and Treatment-related Treatment-emergent Adverse Events (TEAEs) | Treatment-related AE | 4 Participants |
| PF-06882961 15mg BID | Number of Participants With All-causality and Treatment-related Treatment-emergent Adverse Events (TEAEs) | All-causality SAE | 0 Participants |
| PF-06882961 15mg BID | Number of Participants With All-causality and Treatment-related Treatment-emergent Adverse Events (TEAEs) | Treatment-related SAE | 0 Participants |
| PF-06882961 15mg BID | Number of Participants With All-causality and Treatment-related Treatment-emergent Adverse Events (TEAEs) | Treatment-related AE | 4 Participants |
| PF-06882961 15mg BID | Number of Participants With All-causality and Treatment-related Treatment-emergent Adverse Events (TEAEs) | All-causality AE | 8 Participants |
| PF-06882961 50mg BID | Number of Participants With All-causality and Treatment-related Treatment-emergent Adverse Events (TEAEs) | All-causality AE | 10 Participants |
| PF-06882961 50mg BID | Number of Participants With All-causality and Treatment-related Treatment-emergent Adverse Events (TEAEs) | All-causality SAE | 0 Participants |
| PF-06882961 50mg BID | Number of Participants With All-causality and Treatment-related Treatment-emergent Adverse Events (TEAEs) | Treatment-related AE | 10 Participants |
| PF-06882961 50mg BID | Number of Participants With All-causality and Treatment-related Treatment-emergent Adverse Events (TEAEs) | Treatment-related SAE | 0 Participants |
| PF-06882961 70mg BID | Number of Participants With All-causality and Treatment-related Treatment-emergent Adverse Events (TEAEs) | Treatment-related AE | 7 Participants |
| PF-06882961 70mg BID | Number of Participants With All-causality and Treatment-related Treatment-emergent Adverse Events (TEAEs) | All-causality SAE | 0 Participants |
| PF-06882961 70mg BID | Number of Participants With All-causality and Treatment-related Treatment-emergent Adverse Events (TEAEs) | All-causality AE | 8 Participants |
| PF-06882961 70mg BID | Number of Participants With All-causality and Treatment-related Treatment-emergent Adverse Events (TEAEs) | Treatment-related SAE | 0 Participants |
| PF-06882961 120mg BID | Number of Participants With All-causality and Treatment-related Treatment-emergent Adverse Events (TEAEs) | Treatment-related SAE | 0 Participants |
| PF-06882961 120mg BID | Number of Participants With All-causality and Treatment-related Treatment-emergent Adverse Events (TEAEs) | All-causality AE | 8 Participants |
| PF-06882961 120mg BID | Number of Participants With All-causality and Treatment-related Treatment-emergent Adverse Events (TEAEs) | Treatment-related AE | 8 Participants |
| PF-06882961 120mg BID | Number of Participants With All-causality and Treatment-related Treatment-emergent Adverse Events (TEAEs) | All-causality SAE | 0 Participants |
| PF-06882961 120mg BID ST | Number of Participants With All-causality and Treatment-related Treatment-emergent Adverse Events (TEAEs) | Treatment-related AE | 9 Participants |
| PF-06882961 120mg BID ST | Number of Participants With All-causality and Treatment-related Treatment-emergent Adverse Events (TEAEs) | All-causality SAE | 1 Participants |
| PF-06882961 120mg BID ST | Number of Participants With All-causality and Treatment-related Treatment-emergent Adverse Events (TEAEs) | Treatment-related SAE | 0 Participants |
| PF-06882961 120mg BID ST | Number of Participants With All-causality and Treatment-related Treatment-emergent Adverse Events (TEAEs) | All-causality AE | 9 Participants |
| PF-06882961 120mg QD | Number of Participants With All-causality and Treatment-related Treatment-emergent Adverse Events (TEAEs) | All-causality SAE | 0 Participants |
| PF-06882961 120mg QD | Number of Participants With All-causality and Treatment-related Treatment-emergent Adverse Events (TEAEs) | Treatment-related SAE | 0 Participants |
| PF-06882961 120mg QD | Number of Participants With All-causality and Treatment-related Treatment-emergent Adverse Events (TEAEs) | Treatment-related AE | 8 Participants |
| PF-06882961 120mg QD | Number of Participants With All-causality and Treatment-related Treatment-emergent Adverse Events (TEAEs) | All-causality AE | 8 Participants |
| PF-06882961 200mg QD CR | Number of Participants With All-causality and Treatment-related Treatment-emergent Adverse Events (TEAEs) | All-causality AE | 9 Participants |
| PF-06882961 200mg QD CR | Number of Participants With All-causality and Treatment-related Treatment-emergent Adverse Events (TEAEs) | Treatment-related SAE | 0 Participants |
| PF-06882961 200mg QD CR | Number of Participants With All-causality and Treatment-related Treatment-emergent Adverse Events (TEAEs) | Treatment-related AE | 9 Participants |
| PF-06882961 200mg QD CR | Number of Participants With All-causality and Treatment-related Treatment-emergent Adverse Events (TEAEs) | All-causality SAE | 0 Participants |
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | Number of Participants With Laboratory Abnormalities Without Regard to Baseline Abnormality | 24 Participants |
| PF-06882961 10mg BID | Number of Participants With Laboratory Abnormalities Without Regard to Baseline Abnormality | 7 Participants |
| PF-06882961 15mg BID | Number of Participants With Laboratory Abnormalities Without Regard to Baseline Abnormality | 8 Participants |
| PF-06882961 50mg BID | Number of Participants With Laboratory Abnormalities Without Regard to Baseline Abnormality | 10 Participants |
| PF-06882961 70mg BID | Number of Participants With Laboratory Abnormalities Without Regard to Baseline Abnormality | 8 Participants |
| PF-06882961 120mg BID | Number of Participants With Laboratory Abnormalities Without Regard to Baseline Abnormality | 8 Participants |
| PF-06882961 120mg BID ST | Number of Participants With Laboratory Abnormalities Without Regard to Baseline Abnormality | 9 Participants |
| PF-06882961 120mg QD | Number of Participants With Laboratory Abnormalities Without Regard to Baseline Abnormality | 7 Participants |
| PF-06882961 200mg QD CR | Number of Participants With Laboratory Abnormalities Without Regard to Baseline Abnormality | 10 Participants |
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.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Ae24 (%) of PF-06882961 on Day 28 | 0.05747 Percentage | Geometric Coefficient of Variation 36 |
| PF-06882961 10mg BID | Ae24 (%) of PF-06882961 on Day 28 | 0.03360 Percentage | Geometric Coefficient of Variation 69 |
| PF-06882961 15mg BID | Ae24 (%) of PF-06882961 on Day 28 | 0.02942 Percentage | Geometric Coefficient of Variation 242 |
| PF-06882961 50mg BID | Ae24 (%) of PF-06882961 on Day 28 | NA Percentage | — |
| PF-06882961 70mg BID | Ae24 (%) of PF-06882961 on Day 28 | 0.07483 Percentage | Geometric Coefficient of Variation 67 |
| PF-06882961 120mg BID | Ae24 (%) of PF-06882961 on Day 28 | 0.02607 Percentage | Geometric Coefficient of Variation 439 |
| PF-06882961 120mg BID ST | Ae24 (%) of PF-06882961 on Day 28 | 0.03652 Percentage | Geometric Coefficient of Variation 38 |
| PF-06882961 120mg QD | Ae24 (%) of PF-06882961 on Day 28 | 0.04094 Percentage | Geometric Coefficient of Variation 97 |
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.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Amount of Unchanged Drug Recovered in Urine Over 24 Hours (Ae24) of PF-06882961 on Day 28 | 17.25 microgram | Geometric Coefficient of Variation 36 |
| PF-06882961 10mg BID | Amount of Unchanged Drug Recovered in Urine Over 24 Hours (Ae24) of PF-06882961 on Day 28 | 33.60 microgram | Geometric Coefficient of Variation 69 |
| PF-06882961 15mg BID | Amount of Unchanged Drug Recovered in Urine Over 24 Hours (Ae24) of PF-06882961 on Day 28 | 41.16 microgram | Geometric Coefficient of Variation 243 |
| PF-06882961 50mg BID | Amount of Unchanged Drug Recovered in Urine Over 24 Hours (Ae24) of PF-06882961 on Day 28 | NA microgram | — |
| PF-06882961 70mg BID | Amount of Unchanged Drug Recovered in Urine Over 24 Hours (Ae24) of PF-06882961 on Day 28 | 14.97 microgram | Geometric Coefficient of Variation 67 |
| PF-06882961 120mg BID | Amount of Unchanged Drug Recovered in Urine Over 24 Hours (Ae24) of PF-06882961 on Day 28 | 62.63 microgram | Geometric Coefficient of Variation 439 |
| PF-06882961 120mg BID ST | Amount of Unchanged Drug Recovered in Urine Over 24 Hours (Ae24) of PF-06882961 on Day 28 | 72.98 microgram | Geometric Coefficient of Variation 38 |
| PF-06882961 120mg QD | Amount of Unchanged Drug Recovered in Urine Over 24 Hours (Ae24) of PF-06882961 on Day 28 | 49.09 microgram | Geometric Coefficient of Variation 97 |
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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | AUC24 and AUCtau of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | AUC24 on Day 14 or 21 | 853.8 nanogram.hours/milliliter (ng.h/mL) | Geometric Coefficient of Variation 45 |
| Placebo | AUC24 and AUCtau of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | AUCtau1 on Day 1 | 288.1 nanogram.hours/milliliter (ng.h/mL) | Geometric Coefficient of Variation 37 |
| Placebo | AUC24 and AUCtau of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | AUCtau1 on Day 28 | 331.1 nanogram.hours/milliliter (ng.h/mL) | Geometric Coefficient of Variation 40 |
| Placebo | AUC24 and AUCtau of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | AUCtau2 on Day 14 or 21 | 500.1 nanogram.hours/milliliter (ng.h/mL) | Geometric Coefficient of Variation 46 |
| Placebo | AUC24 and AUCtau of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | AUCtau2 on Day 28 | 534.7 nanogram.hours/milliliter (ng.h/mL) | Geometric Coefficient of Variation 46 |
| Placebo | AUC24 and AUCtau of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | AUC24 on Day 28 | 876.7 nanogram.hours/milliliter (ng.h/mL) | Geometric Coefficient of Variation 41 |
| Placebo | AUC24 and AUCtau of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | AUCtau1 on Day 14 or 21 | 348.6 nanogram.hours/milliliter (ng.h/mL) | Geometric Coefficient of Variation 48 |
| Placebo | AUC24 and AUCtau of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | AUCtau2 on Day 1 | 414.8 nanogram.hours/milliliter (ng.h/mL) | Geometric Coefficient of Variation 50 |
| Placebo | AUC24 and AUCtau of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | AUC24 on Day 1 | 707.5 nanogram.hours/milliliter (ng.h/mL) | Geometric Coefficient of Variation 43 |
| PF-06882961 10mg BID | AUC24 and AUCtau of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | AUCtau2 on Day 1 | 678.5 nanogram.hours/milliliter (ng.h/mL) | Geometric Coefficient of Variation 79 |
| PF-06882961 10mg BID | AUC24 and AUCtau of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | AUC24 on Day 28 | 1653 nanogram.hours/milliliter (ng.h/mL) | Geometric Coefficient of Variation 55 |
| PF-06882961 10mg BID | AUC24 and AUCtau of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | AUC24 on Day 1 | 1502 nanogram.hours/milliliter (ng.h/mL) | Geometric Coefficient of Variation 29 |
| PF-06882961 10mg BID | AUC24 and AUCtau of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | AUCtau1 on Day 28 | 671.1 nanogram.hours/milliliter (ng.h/mL) | Geometric Coefficient of Variation 35 |
| PF-06882961 10mg BID | AUC24 and AUCtau of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | AUC24 on Day 14 or 21 | 2092 nanogram.hours/milliliter (ng.h/mL) | Geometric Coefficient of Variation 91 |
| PF-06882961 10mg BID | AUC24 and AUCtau of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | AUCtau1 on Day 14 or 21 | 880.3 nanogram.hours/milliliter (ng.h/mL) | Geometric Coefficient of Variation 78 |
| PF-06882961 10mg BID | AUC24 and AUCtau of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | AUCtau2 on Day 28 | 960.1 nanogram.hours/milliliter (ng.h/mL) | Geometric Coefficient of Variation 73 |
| PF-06882961 10mg BID | AUC24 and AUCtau of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | AUCtau1 on Day 1 | 741.4 nanogram.hours/milliliter (ng.h/mL) | Geometric Coefficient of Variation 35 |
| PF-06882961 10mg BID | AUC24 and AUCtau of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | AUCtau2 on Day 14 or 21 | 1175 nanogram.hours/milliliter (ng.h/mL) | Geometric Coefficient of Variation 110 |
| PF-06882961 15mg BID | AUC24 and AUCtau of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | AUCtau2 on Day 1 | 364.9 nanogram.hours/milliliter (ng.h/mL) | Geometric Coefficient of Variation 56 |
| PF-06882961 15mg BID | AUC24 and AUCtau of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | AUCtau2 on Day 14 or 21 | 1517 nanogram.hours/milliliter (ng.h/mL) | Geometric Coefficient of Variation 53 |
| PF-06882961 15mg BID | AUC24 and AUCtau of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | AUCtau2 on Day 28 | 1970 nanogram.hours/milliliter (ng.h/mL) | Geometric Coefficient of Variation 68 |
| PF-06882961 15mg BID | AUC24 and AUCtau of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | AUCtau1 on Day 1 | 279.7 nanogram.hours/milliliter (ng.h/mL) | Geometric Coefficient of Variation 49 |
| PF-06882961 15mg BID | AUC24 and AUCtau of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | AUC24 on Day 1 | 645.8 nanogram.hours/milliliter (ng.h/mL) | Geometric Coefficient of Variation 52 |
| PF-06882961 15mg BID | AUC24 and AUCtau of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | AUCtau1 on Day 28 | 1153 nanogram.hours/milliliter (ng.h/mL) | Geometric Coefficient of Variation 44 |
| PF-06882961 15mg BID | AUC24 and AUCtau of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | AUC24 on Day 28 | 3171 nanogram.hours/milliliter (ng.h/mL) | Geometric Coefficient of Variation 56 |
| PF-06882961 15mg BID | AUC24 and AUCtau of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | AUC24 on Day 14 or 21 | 2988 nanogram.hours/milliliter (ng.h/mL) | Geometric Coefficient of Variation 59 |
| PF-06882961 15mg BID | AUC24 and AUCtau of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | AUCtau1 on Day 14 or 21 | 1462 nanogram.hours/milliliter (ng.h/mL) | Geometric Coefficient of Variation 70 |
| PF-06882961 50mg BID | AUC24 and AUCtau of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | AUC24 on Day 14 or 21 | 8149 nanogram.hours/milliliter (ng.h/mL) | Geometric Coefficient of Variation 84 |
| PF-06882961 50mg BID | AUC24 and AUCtau of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | AUC24 on Day 1 | 666.1 nanogram.hours/milliliter (ng.h/mL) | Geometric Coefficient of Variation 54 |
| PF-06882961 50mg BID | AUC24 and AUCtau of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | AUCtau2 on Day 1 | 401.9 nanogram.hours/milliliter (ng.h/mL) | Geometric Coefficient of Variation 62 |
| PF-06882961 50mg BID | AUC24 and AUCtau of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | AUCtau1 on Day 28 | 3534 nanogram.hours/milliliter (ng.h/mL) | Geometric Coefficient of Variation 87 |
| PF-06882961 50mg BID | AUC24 and AUCtau of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | AUCtau1 on Day 1 | 260.3 nanogram.hours/milliliter (ng.h/mL) | Geometric Coefficient of Variation 45 |
| PF-06882961 50mg BID | AUC24 and AUCtau of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | AUCtau2 on Day 28 | 4852 nanogram.hours/milliliter (ng.h/mL) | Geometric Coefficient of Variation 74 |
| PF-06882961 50mg BID | AUC24 and AUCtau of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | AUCtau2 on Day 14 or 21 | 4361 nanogram.hours/milliliter (ng.h/mL) | Geometric Coefficient of Variation 89 |
| PF-06882961 50mg BID | AUC24 and AUCtau of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | AUC24 on Day 28 | 8368 nanogram.hours/milliliter (ng.h/mL) | Geometric Coefficient of Variation 79 |
| PF-06882961 50mg BID | AUC24 and AUCtau of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | AUCtau1 on Day 14 or 21 | 3772 nanogram.hours/milliliter (ng.h/mL) | Geometric Coefficient of Variation 85 |
| PF-06882961 70mg BID | AUC24 and AUCtau of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | AUCtau1 on Day 14 or 21 | 85.57 nanogram.hours/milliliter (ng.h/mL) | Geometric Coefficient of Variation 59 |
| PF-06882961 70mg BID | AUC24 and AUCtau of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | AUC24 on Day 1 | 178.7 nanogram.hours/milliliter (ng.h/mL) | Geometric Coefficient of Variation 72 |
| PF-06882961 70mg BID | AUC24 and AUCtau of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | AUCtau1 on Day 1 | 74.50 nanogram.hours/milliliter (ng.h/mL) | Geometric Coefficient of Variation 66 |
| PF-06882961 70mg BID | AUC24 and AUCtau of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | AUCtau2 on Day 1 | 103.7 nanogram.hours/milliliter (ng.h/mL) | Geometric Coefficient of Variation 76 |
| PF-06882961 70mg BID | AUC24 and AUCtau of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | AUC24 on Day 14 or 21 | 201.6 nanogram.hours/milliliter (ng.h/mL) | Geometric Coefficient of Variation 63 |
| PF-06882961 70mg BID | AUC24 and AUCtau of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | AUCtau2 on Day 14 or 21 | 115.4 nanogram.hours/milliliter (ng.h/mL) | Geometric Coefficient of Variation 68 |
| PF-06882961 70mg BID | AUC24 and AUCtau of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | AUC24 on Day 28 | 455.9 nanogram.hours/milliliter (ng.h/mL) | Geometric Coefficient of Variation 66 |
| PF-06882961 70mg BID | AUC24 and AUCtau of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | AUCtau1 on Day 28 | 190.8 nanogram.hours/milliliter (ng.h/mL) | Geometric Coefficient of Variation 60 |
| PF-06882961 70mg BID | AUC24 and AUCtau of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | AUCtau2 on Day 28 | 261.0 nanogram.hours/milliliter (ng.h/mL) | Geometric Coefficient of Variation 72 |
| PF-06882961 120mg BID | AUC24 and AUCtau of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | AUC24 on Day 28 | 5973 nanogram.hours/milliliter (ng.h/mL) | Geometric Coefficient of Variation 87 |
| PF-06882961 120mg BID | AUC24 and AUCtau of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | AUC24 on Day 1 | 324.0 nanogram.hours/milliliter (ng.h/mL) | Geometric Coefficient of Variation 41 |
| PF-06882961 120mg BID | AUC24 and AUCtau of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | AUCtau2 on Day 28 | 3668 nanogram.hours/milliliter (ng.h/mL) | Geometric Coefficient of Variation 91 |
| PF-06882961 120mg BID | AUC24 and AUCtau of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | AUCtau2 on Day 1 | 176.4 nanogram.hours/milliliter (ng.h/mL) | Geometric Coefficient of Variation 42 |
| PF-06882961 120mg BID | AUC24 and AUCtau of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | AUC24 on Day 14 or 21 | 2660 nanogram.hours/milliliter (ng.h/mL) | Geometric Coefficient of Variation 76 |
| PF-06882961 120mg BID | AUC24 and AUCtau of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | AUCtau1 on Day 1 | 147.7 nanogram.hours/milliliter (ng.h/mL) | Geometric Coefficient of Variation 43 |
| PF-06882961 120mg BID | AUC24 and AUCtau of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | AUCtau1 on Day 14 or 21 | 957.3 nanogram.hours/milliliter (ng.h/mL) | Geometric Coefficient of Variation 66 |
| PF-06882961 120mg BID | AUC24 and AUCtau of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | AUCtau1 on Day 28 | 2249 nanogram.hours/milliliter (ng.h/mL) | Geometric Coefficient of Variation 88 |
| PF-06882961 120mg BID | AUC24 and AUCtau of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | AUCtau2 on Day 14 or 21 | 1693 nanogram.hours/milliliter (ng.h/mL) | Geometric Coefficient of Variation 83 |
| PF-06882961 120mg BID ST | AUC24 and AUCtau of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | AUCtau1 on Day 28 | NA nanogram.hours/milliliter (ng.h/mL) | — |
| PF-06882961 120mg BID ST | AUC24 and AUCtau of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | AUCtau2 on Day 1 | NA nanogram.hours/milliliter (ng.h/mL) | — |
| PF-06882961 120mg BID ST | AUC24 and AUCtau of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | AUC24 on Day 1 | 393.9 nanogram.hours/milliliter (ng.h/mL) | Geometric Coefficient of Variation 80 |
| PF-06882961 120mg BID ST | AUC24 and AUCtau of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | AUCtau1 on Day 14 or 21 | NA nanogram.hours/milliliter (ng.h/mL) | — |
| PF-06882961 120mg BID ST | AUC24 and AUCtau of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | AUC24 on Day 28 | 4372 nanogram.hours/milliliter (ng.h/mL) | Geometric Coefficient of Variation 31 |
| PF-06882961 120mg BID ST | AUC24 and AUCtau of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | AUC24 on Day 14 or 21 | 1291 nanogram.hours/milliliter (ng.h/mL) | Geometric Coefficient of Variation 68 |
| PF-06882961 120mg BID ST | AUC24 and AUCtau of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | AUCtau1 on Day 1 | NA nanogram.hours/milliliter (ng.h/mL) | — |
| PF-06882961 120mg BID ST | AUC24 and AUCtau of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | AUCtau2 on Day 28 | NA nanogram.hours/milliliter (ng.h/mL) | — |
| PF-06882961 120mg BID ST | AUC24 and AUCtau of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | AUCtau2 on Day 14 or 21 | NA nanogram.hours/milliliter (ng.h/mL) | — |
| PF-06882961 120mg QD | AUC24 and AUCtau of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | AUCtau2 on Day 28 | NA nanogram.hours/milliliter (ng.h/mL) | — |
| PF-06882961 120mg QD | AUC24 and AUCtau of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | AUC24 on Day 14 or 21 | 1204 nanogram.hours/milliliter (ng.h/mL) | Geometric Coefficient of Variation 43 |
| PF-06882961 120mg QD | AUC24 and AUCtau of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | AUCtau2 on Day 14 or 21 | NA nanogram.hours/milliliter (ng.h/mL) | — |
| PF-06882961 120mg QD | AUC24 and AUCtau of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | AUCtau2 on Day 1 | NA nanogram.hours/milliliter (ng.h/mL) | — |
| PF-06882961 120mg QD | AUC24 and AUCtau of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | AUC24 on Day 28 | 2723 nanogram.hours/milliliter (ng.h/mL) | Geometric Coefficient of Variation 39 |
| PF-06882961 120mg QD | AUC24 and AUCtau of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | AUCtau1 on Day 1 | NA nanogram.hours/milliliter (ng.h/mL) | — |
| PF-06882961 120mg QD | AUC24 and AUCtau of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | AUCtau1 on Day 28 | NA nanogram.hours/milliliter (ng.h/mL) | — |
| PF-06882961 120mg QD | AUC24 and AUCtau of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | AUC24 on Day 1 | 184.6 nanogram.hours/milliliter (ng.h/mL) | Geometric Coefficient of Variation 49 |
| PF-06882961 120mg QD | AUC24 and AUCtau of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | AUCtau1 on Day 14 or 21 | NA nanogram.hours/milliliter (ng.h/mL) | — |
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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Maximum Plasma Concentration (Cmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | Cmax1 on Day 28 | 50.24 nanogram/milliliter (ng/mL) | Geometric Coefficient of Variation 44 |
| Placebo | Maximum Plasma Concentration (Cmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | Cmax on Day 14 or 21 | 65.78 nanogram/milliliter (ng/mL) | Geometric Coefficient of Variation 35 |
| Placebo | Maximum Plasma Concentration (Cmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | Cmax on Day 28 | 81.56 nanogram/milliliter (ng/mL) | Geometric Coefficient of Variation 32 |
| Placebo | Maximum Plasma Concentration (Cmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | Cmax2 on Day 14 or 21 | 63.89 nanogram/milliliter (ng/mL) | Geometric Coefficient of Variation 36 |
| Placebo | Maximum Plasma Concentration (Cmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | Cmax2 on Day 28 | 74.22 nanogram/milliliter (ng/mL) | Geometric Coefficient of Variation 37 |
| Placebo | Maximum Plasma Concentration (Cmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | Cmax1 on Day 1 | 42.69 nanogram/milliliter (ng/mL) | Geometric Coefficient of Variation 29 |
| Placebo | Maximum Plasma Concentration (Cmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | Cmax1 on Day 14 or 21 | 55.00 nanogram/milliliter (ng/mL) | Geometric Coefficient of Variation 43 |
| Placebo | Maximum Plasma Concentration (Cmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | Cmax2 on Day 1 | 40.63 nanogram/milliliter (ng/mL) | Geometric Coefficient of Variation 66 |
| Placebo | Maximum Plasma Concentration (Cmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | Cmax on Day 1 | 50.58 nanogram/milliliter (ng/mL) | Geometric Coefficient of Variation 40 |
| PF-06882961 10mg BID | Maximum Plasma Concentration (Cmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | Cmax2 on Day 1 | 68.77 nanogram/milliliter (ng/mL) | Geometric Coefficient of Variation 51 |
| PF-06882961 10mg BID | Maximum Plasma Concentration (Cmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | Cmax on Day 1 | 124.4 nanogram/milliliter (ng/mL) | Geometric Coefficient of Variation 51 |
| PF-06882961 10mg BID | Maximum Plasma Concentration (Cmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | Cmax on Day 14 or 21 | 149.8 nanogram/milliliter (ng/mL) | Geometric Coefficient of Variation 88 |
| PF-06882961 10mg BID | Maximum Plasma Concentration (Cmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | Cmax1 on Day 28 | 103.8 nanogram/milliliter (ng/mL) | Geometric Coefficient of Variation 50 |
| PF-06882961 10mg BID | Maximum Plasma Concentration (Cmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | Cmax1 on Day 14 or 21 | 130.2 nanogram/milliliter (ng/mL) | Geometric Coefficient of Variation 85 |
| PF-06882961 10mg BID | Maximum Plasma Concentration (Cmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | Cmax2 on Day 28 | 117.2 nanogram/milliliter (ng/mL) | Geometric Coefficient of Variation 63 |
| PF-06882961 10mg BID | Maximum Plasma Concentration (Cmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | Cmax1 on Day 1 | 119.1 nanogram/milliliter (ng/mL) | Geometric Coefficient of Variation 56 |
| PF-06882961 10mg BID | Maximum Plasma Concentration (Cmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | Cmax2 on Day 14 or 21 | 127.9 nanogram/milliliter (ng/mL) | Geometric Coefficient of Variation 86 |
| PF-06882961 10mg BID | Maximum Plasma Concentration (Cmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | Cmax on Day 28 | 133.7 nanogram/milliliter (ng/mL) | Geometric Coefficient of Variation 69 |
| PF-06882961 15mg BID | Maximum Plasma Concentration (Cmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | Cmax2 on Day 1 | 42.33 nanogram/milliliter (ng/mL) | Geometric Coefficient of Variation 59 |
| PF-06882961 15mg BID | Maximum Plasma Concentration (Cmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | Cmax2 on Day 14 or 21 | 202.8 nanogram/milliliter (ng/mL) | Geometric Coefficient of Variation 50 |
| PF-06882961 15mg BID | Maximum Plasma Concentration (Cmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | Cmax2 on Day 28 | 306.5 nanogram/milliliter (ng/mL) | Geometric Coefficient of Variation 49 |
| PF-06882961 15mg BID | Maximum Plasma Concentration (Cmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | Cmax1 on Day 1 | 45.01 nanogram/milliliter (ng/mL) | Geometric Coefficient of Variation 48 |
| PF-06882961 15mg BID | Maximum Plasma Concentration (Cmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | Cmax on Day 1 | 49.75 nanogram/milliliter (ng/mL) | Geometric Coefficient of Variation 50 |
| PF-06882961 15mg BID | Maximum Plasma Concentration (Cmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | Cmax1 on Day 28 | 197.9 nanogram/milliliter (ng/mL) | Geometric Coefficient of Variation 51 |
| PF-06882961 15mg BID | Maximum Plasma Concentration (Cmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | Cmax on Day 14 or 21 | 253.6 nanogram/milliliter (ng/mL) | Geometric Coefficient of Variation 76 |
| PF-06882961 15mg BID | Maximum Plasma Concentration (Cmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | Cmax on Day 28 | 328.8 nanogram/milliliter (ng/mL) | Geometric Coefficient of Variation 49 |
| PF-06882961 15mg BID | Maximum Plasma Concentration (Cmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | Cmax1 on Day 14 or 21 | 235.1 nanogram/milliliter (ng/mL) | Geometric Coefficient of Variation 84 |
| PF-06882961 50mg BID | Maximum Plasma Concentration (Cmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | Cmax on Day 14 or 21 | 788.4 nanogram/milliliter (ng/mL) | Geometric Coefficient of Variation 89 |
| PF-06882961 50mg BID | Maximum Plasma Concentration (Cmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | Cmax2 on Day 1 | 44.97 nanogram/milliliter (ng/mL) | Geometric Coefficient of Variation 61 |
| PF-06882961 50mg BID | Maximum Plasma Concentration (Cmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | Cmax1 on Day 14 or 21 | 682.7 nanogram/milliliter (ng/mL) | Geometric Coefficient of Variation 92 |
| PF-06882961 50mg BID | Maximum Plasma Concentration (Cmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | Cmax1 on Day 28 | 649.2 nanogram/milliliter (ng/mL) | Geometric Coefficient of Variation 90 |
| PF-06882961 50mg BID | Maximum Plasma Concentration (Cmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | Cmax1 on Day 1 | 36.51 nanogram/milliliter (ng/mL) | Geometric Coefficient of Variation 43 |
| PF-06882961 50mg BID | Maximum Plasma Concentration (Cmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | Cmax2 on Day 28 | 617.9 nanogram/milliliter (ng/mL) | Geometric Coefficient of Variation 93 |
| PF-06882961 50mg BID | Maximum Plasma Concentration (Cmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | Cmax on Day 28 | 685.2 nanogram/milliliter (ng/mL) | Geometric Coefficient of Variation 87 |
| PF-06882961 50mg BID | Maximum Plasma Concentration (Cmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | Cmax on Day 1 | 51.61 nanogram/milliliter (ng/mL) | Geometric Coefficient of Variation 50 |
| PF-06882961 50mg BID | Maximum Plasma Concentration (Cmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | Cmax2 on Day 14 or 21 | 505.3 nanogram/milliliter (ng/mL) | Geometric Coefficient of Variation 93 |
| PF-06882961 70mg BID | Maximum Plasma Concentration (Cmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | Cmax1 on Day 14 or 21 | 15.31 nanogram/milliliter (ng/mL) | Geometric Coefficient of Variation 50 |
| PF-06882961 70mg BID | Maximum Plasma Concentration (Cmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | Cmax on Day 1 | 15.02 nanogram/milliliter (ng/mL) | Geometric Coefficient of Variation 70 |
| PF-06882961 70mg BID | Maximum Plasma Concentration (Cmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | Cmax1 on Day 1 | 12.82 nanogram/milliliter (ng/mL) | Geometric Coefficient of Variation 58 |
| PF-06882961 70mg BID | Maximum Plasma Concentration (Cmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | Cmax2 on Day 1 | 13.98 nanogram/milliliter (ng/mL) | Geometric Coefficient of Variation 75 |
| PF-06882961 70mg BID | Maximum Plasma Concentration (Cmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | Cmax on Day 14 or 21 | 18.63 nanogram/milliliter (ng/mL) | Geometric Coefficient of Variation 47 |
| PF-06882961 70mg BID | Maximum Plasma Concentration (Cmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | Cmax2 on Day 14 or 21 | 17.16 nanogram/milliliter (ng/mL) | Geometric Coefficient of Variation 58 |
| PF-06882961 70mg BID | Maximum Plasma Concentration (Cmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | Cmax on Day 28 | 38.38 nanogram/milliliter (ng/mL) | Geometric Coefficient of Variation 58 |
| PF-06882961 70mg BID | Maximum Plasma Concentration (Cmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | Cmax1 on Day 28 | 30.42 nanogram/milliliter (ng/mL) | Geometric Coefficient of Variation 52 |
| PF-06882961 70mg BID | Maximum Plasma Concentration (Cmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | Cmax2 on Day 28 | 35.01 nanogram/milliliter (ng/mL) | Geometric Coefficient of Variation 56 |
| PF-06882961 120mg BID | Maximum Plasma Concentration (Cmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | Cmax1 on Day 1 | 24.06 nanogram/milliliter (ng/mL) | Geometric Coefficient of Variation 42 |
| PF-06882961 120mg BID | Maximum Plasma Concentration (Cmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | Cmax on Day 1 | 26.02 nanogram/milliliter (ng/mL) | Geometric Coefficient of Variation 39 |
| PF-06882961 120mg BID | Maximum Plasma Concentration (Cmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | Cmax on Day 28 | 437.6 nanogram/milliliter (ng/mL) | Geometric Coefficient of Variation 94 |
| PF-06882961 120mg BID | Maximum Plasma Concentration (Cmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | Cmax2 on Day 1 | 21.64 nanogram/milliliter (ng/mL) | Geometric Coefficient of Variation 41 |
| PF-06882961 120mg BID | Maximum Plasma Concentration (Cmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | Cmax on Day 14 or 21 | 188.5 nanogram/milliliter (ng/mL) | Geometric Coefficient of Variation 57 |
| PF-06882961 120mg BID | Maximum Plasma Concentration (Cmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | Cmax2 on Day 28 | 410.3 nanogram/milliliter (ng/mL) | Geometric Coefficient of Variation 90 |
| PF-06882961 120mg BID | Maximum Plasma Concentration (Cmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | Cmax1 on Day 14 or 21 | 143.0 nanogram/milliliter (ng/mL) | Geometric Coefficient of Variation 71 |
| PF-06882961 120mg BID | Maximum Plasma Concentration (Cmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | Cmax1 on Day 28 | 357.1 nanogram/milliliter (ng/mL) | Geometric Coefficient of Variation 84 |
| PF-06882961 120mg BID | Maximum Plasma Concentration (Cmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | Cmax2 on Day 14 or 21 | 178.4 nanogram/milliliter (ng/mL) | Geometric Coefficient of Variation 56 |
| PF-06882961 120mg BID ST | Maximum Plasma Concentration (Cmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | Cmax1 on Day 28 | NA nanogram/milliliter (ng/mL) | — |
| PF-06882961 120mg BID ST | Maximum Plasma Concentration (Cmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | Cmax on Day 1 | 28.67 nanogram/milliliter (ng/mL) | Geometric Coefficient of Variation 87 |
| PF-06882961 120mg BID ST | Maximum Plasma Concentration (Cmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | Cmax1 on Day 14 or 21 | NA nanogram/milliliter (ng/mL) | — |
| PF-06882961 120mg BID ST | Maximum Plasma Concentration (Cmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | Cmax on Day 28 | 303.9 nanogram/milliliter (ng/mL) | Geometric Coefficient of Variation 32 |
| PF-06882961 120mg BID ST | Maximum Plasma Concentration (Cmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | Cmax on Day 14 or 21 | 98.11 nanogram/milliliter (ng/mL) | Geometric Coefficient of Variation 54 |
| PF-06882961 120mg BID ST | Maximum Plasma Concentration (Cmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | Cmax2 on Day 1 | NA nanogram/milliliter (ng/mL) | — |
| PF-06882961 120mg BID ST | Maximum Plasma Concentration (Cmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | Cmax1 on Day 1 | NA nanogram/milliliter (ng/mL) | — |
| PF-06882961 120mg BID ST | Maximum Plasma Concentration (Cmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | Cmax2 on Day 28 | NA nanogram/milliliter (ng/mL) | — |
| PF-06882961 120mg BID ST | Maximum Plasma Concentration (Cmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | Cmax2 on Day 14 or 21 | NA nanogram/milliliter (ng/mL) | — |
| PF-06882961 120mg QD | Maximum Plasma Concentration (Cmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | Cmax2 on Day 28 | NA nanogram/milliliter (ng/mL) | — |
| PF-06882961 120mg QD | Maximum Plasma Concentration (Cmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | Cmax2 on Day 14 or 21 | NA nanogram/milliliter (ng/mL) | — |
| PF-06882961 120mg QD | Maximum Plasma Concentration (Cmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | Cmax on Day 14 or 21 | 100.7 nanogram/milliliter (ng/mL) | Geometric Coefficient of Variation 35 |
| PF-06882961 120mg QD | Maximum Plasma Concentration (Cmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | Cmax2 on Day 1 | NA nanogram/milliliter (ng/mL) | — |
| PF-06882961 120mg QD | Maximum Plasma Concentration (Cmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | Cmax on Day 28 | 192.2 nanogram/milliliter (ng/mL) | Geometric Coefficient of Variation 52 |
| PF-06882961 120mg QD | Maximum Plasma Concentration (Cmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | Cmax1 on Day 1 | NA nanogram/milliliter (ng/mL) | — |
| PF-06882961 120mg QD | Maximum Plasma Concentration (Cmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | Cmax1 on Day 28 | NA nanogram/milliliter (ng/mL) | — |
| PF-06882961 120mg QD | Maximum Plasma Concentration (Cmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | Cmax on Day 1 | 20.40 nanogram/milliliter (ng/mL) | Geometric Coefficient of Variation 29 |
| PF-06882961 120mg QD | Maximum Plasma Concentration (Cmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | Cmax1 on Day 14 or 21 | NA nanogram/milliliter (ng/mL) | — |
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.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Renal Clearance (CLr) of PF-06882961 on Day 28 | 0.3273 mL/min | Geometric Coefficient of Variation 18 |
| PF-06882961 10mg BID | Renal Clearance (CLr) of PF-06882961 on Day 28 | 0.3385 mL/min | Geometric Coefficient of Variation 18 |
| PF-06882961 15mg BID | Renal Clearance (CLr) of PF-06882961 on Day 28 | 0.3094 mL/min | Geometric Coefficient of Variation 70 |
| PF-06882961 50mg BID | Renal Clearance (CLr) of PF-06882961 on Day 28 | NA mL/min | — |
| PF-06882961 70mg BID | Renal Clearance (CLr) of PF-06882961 on Day 28 | 0.5470 mL/min | Geometric Coefficient of Variation 26 |
| PF-06882961 120mg BID | Renal Clearance (CLr) of PF-06882961 on Day 28 | 0.2006 mL/min | Geometric Coefficient of Variation 228 |
| PF-06882961 120mg BID ST | Renal Clearance (CLr) of PF-06882961 on Day 28 | 0.2895 mL/min | Geometric Coefficient of Variation 21 |
| PF-06882961 120mg QD | Renal Clearance (CLr) of PF-06882961 on Day 28 | 0.3178 mL/min | Geometric Coefficient of Variation 73 |
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Terminal Half-life (t½) of PF-06882961 on Day 28 | 5.100 hours | Standard Deviation 1.2186 |
| PF-06882961 10mg BID | Terminal Half-life (t½) of PF-06882961 on Day 28 | 5.067 hours | Standard Deviation 0.75593 |
| PF-06882961 15mg BID | Terminal Half-life (t½) of PF-06882961 on Day 28 | 4.681 hours | Standard Deviation 0.59504 |
| PF-06882961 50mg BID | Terminal Half-life (t½) of PF-06882961 on Day 28 | 6.203 hours | Standard Deviation 2.3505 |
| PF-06882961 70mg BID | Terminal Half-life (t½) of PF-06882961 on Day 28 | 8.090 hours | Standard Deviation 3.3234 |
| PF-06882961 120mg BID | Terminal Half-life (t½) of PF-06882961 on Day 28 | 6.730 hours | Standard Deviation 2.5056 |
| PF-06882961 120mg BID ST | Terminal Half-life (t½) of PF-06882961 on Day 28 | 5.773 hours | Standard Deviation 1.4876 |
| PF-06882961 120mg QD | Terminal Half-life (t½) of PF-06882961 on Day 28 | 4.954 hours | Standard Deviation 0.58819 |
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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Placebo | Time for Cmax (Tmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | Tmax on Day 28 | NA hours |
| Placebo | Time for Cmax (Tmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | Tmax2 on Day 28 | 12.0 hours |
| Placebo | Time for Cmax (Tmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | Tmax2 on Day 1 | 14.0 hours |
| Placebo | Time for Cmax (Tmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | Tmax1 on Day 28 | 5.00 hours |
| Placebo | Time for Cmax (Tmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | Tmax2 on Day 14 or 21 | 13.0 hours |
| Placebo | Time for Cmax (Tmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | Tmax on Day 1 | NA hours |
| Placebo | Time for Cmax (Tmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | Tmax1 on Day 14 or 21 | 4.00 hours |
| Placebo | Time for Cmax (Tmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | Tmax on Day 14 or 21 | NA hours |
| Placebo | Time for Cmax (Tmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | Tmax1 on Day 1 | 4.00 hours |
| PF-06882961 10mg BID | Time for Cmax (Tmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | Tmax on Day 1 | NA hours |
| PF-06882961 10mg BID | Time for Cmax (Tmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | Tmax on Day 28 | NA hours |
| PF-06882961 10mg BID | Time for Cmax (Tmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | Tmax1 on Day 1 | 4.00 hours |
| PF-06882961 10mg BID | Time for Cmax (Tmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | Tmax2 on Day 28 | 12.0 hours |
| PF-06882961 10mg BID | Time for Cmax (Tmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | Tmax2 on Day 1 | 14.0 hours |
| PF-06882961 10mg BID | Time for Cmax (Tmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | Tmax on Day 14 or 21 | NA hours |
| PF-06882961 10mg BID | Time for Cmax (Tmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | Tmax1 on Day 14 or 21 | 4.00 hours |
| PF-06882961 10mg BID | Time for Cmax (Tmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | Tmax1 on Day 28 | 3.00 hours |
| PF-06882961 10mg BID | Time for Cmax (Tmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | Tmax2 on Day 14 or 21 | 13.0 hours |
| PF-06882961 15mg BID | Time for Cmax (Tmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | Tmax2 on Day 14 or 21 | 12.0 hours |
| PF-06882961 15mg BID | Time for Cmax (Tmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | Tmax on Day 14 or 21 | NA hours |
| PF-06882961 15mg BID | Time for Cmax (Tmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | Tmax1 on Day 1 | 2.00 hours |
| PF-06882961 15mg BID | Time for Cmax (Tmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | Tmax on Day 1 | NA hours |
| PF-06882961 15mg BID | Time for Cmax (Tmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | Tmax2 on Day 28 | 12.0 hours |
| PF-06882961 15mg BID | Time for Cmax (Tmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | Tmax on Day 28 | NA hours |
| PF-06882961 15mg BID | Time for Cmax (Tmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | Tmax1 on Day 14 or 21 | 1.05 hours |
| PF-06882961 15mg BID | Time for Cmax (Tmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | Tmax1 on Day 28 | 6.00 hours |
| PF-06882961 15mg BID | Time for Cmax (Tmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | Tmax2 on Day 1 | 14.0 hours |
| PF-06882961 50mg BID | Time for Cmax (Tmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | Tmax2 on Day 28 | 12.0 hours |
| PF-06882961 50mg BID | Time for Cmax (Tmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | Tmax1 on Day 1 | 4.00 hours |
| PF-06882961 50mg BID | Time for Cmax (Tmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | Tmax on Day 14 or 21 | NA hours |
| PF-06882961 50mg BID | Time for Cmax (Tmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | Tmax on Day 1 | NA hours |
| PF-06882961 50mg BID | Time for Cmax (Tmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | Tmax1 on Day 28 | 4.00 hours |
| PF-06882961 50mg BID | Time for Cmax (Tmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | Tmax2 on Day 1 | 14.0 hours |
| PF-06882961 50mg BID | Time for Cmax (Tmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | Tmax2 on Day 14 or 21 | 12.0 hours |
| PF-06882961 50mg BID | Time for Cmax (Tmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | Tmax1 on Day 14 or 21 | 1.54 hours |
| PF-06882961 50mg BID | Time for Cmax (Tmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | Tmax on Day 28 | NA hours |
| PF-06882961 70mg BID | Time for Cmax (Tmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | Tmax on Day 28 | NA hours |
| PF-06882961 70mg BID | Time for Cmax (Tmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | Tmax2 on Day 1 | 12.0 hours |
| PF-06882961 70mg BID | Time for Cmax (Tmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | Tmax1 on Day 28 | 4.00 hours |
| PF-06882961 70mg BID | Time for Cmax (Tmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | Tmax on Day 14 or 21 | NA hours |
| PF-06882961 70mg BID | Time for Cmax (Tmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | Tmax on Day 1 | NA hours |
| PF-06882961 70mg BID | Time for Cmax (Tmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | Tmax2 on Day 28 | 12.0 hours |
| PF-06882961 70mg BID | Time for Cmax (Tmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | Tmax1 on Day 14 or 21 | 6.00 hours |
| PF-06882961 70mg BID | Time for Cmax (Tmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | Tmax2 on Day 14 or 21 | 12.0 hours |
| PF-06882961 70mg BID | Time for Cmax (Tmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | Tmax1 on Day 1 | 2.00 hours |
| PF-06882961 120mg BID | Time for Cmax (Tmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | Tmax1 on Day 14 or 21 | 6.00 hours |
| PF-06882961 120mg BID | Time for Cmax (Tmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | Tmax on Day 1 | NA hours |
| PF-06882961 120mg BID | Time for Cmax (Tmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | Tmax1 on Day 1 | 2.00 hours |
| PF-06882961 120mg BID | Time for Cmax (Tmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | Tmax2 on Day 1 | 14.0 hours |
| PF-06882961 120mg BID | Time for Cmax (Tmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | Tmax on Day 14 or 21 | NA hours |
| PF-06882961 120mg BID | Time for Cmax (Tmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | Tmax2 on Day 14 or 21 | 14.0 hours |
| PF-06882961 120mg BID | Time for Cmax (Tmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | Tmax on Day 28 | NA hours |
| PF-06882961 120mg BID | Time for Cmax (Tmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | Tmax1 on Day 28 | 6.00 hours |
| PF-06882961 120mg BID | Time for Cmax (Tmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | Tmax2 on Day 28 | 12.0 hours |
| PF-06882961 120mg BID ST | Time for Cmax (Tmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | Tmax on Day 28 | 14.0 hours |
| PF-06882961 120mg BID ST | Time for Cmax (Tmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | Tmax2 on Day 14 or 21 | NA hours |
| PF-06882961 120mg BID ST | Time for Cmax (Tmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | Tmax1 on Day 14 or 21 | NA hours |
| PF-06882961 120mg BID ST | Time for Cmax (Tmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | Tmax on Day 14 or 21 | 12.0 hours |
| PF-06882961 120mg BID ST | Time for Cmax (Tmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | Tmax1 on Day 28 | NA hours |
| PF-06882961 120mg BID ST | Time for Cmax (Tmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | Tmax2 on Day 1 | NA hours |
| PF-06882961 120mg BID ST | Time for Cmax (Tmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | Tmax1 on Day 1 | NA hours |
| PF-06882961 120mg BID ST | Time for Cmax (Tmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | Tmax on Day 1 | 13.0 hours |
| PF-06882961 120mg BID ST | Time for Cmax (Tmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | Tmax2 on Day 28 | NA hours |
| PF-06882961 120mg QD | Time for Cmax (Tmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | Tmax on Day 14 or 21 | 6.00 hours |
| PF-06882961 120mg QD | Time for Cmax (Tmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | Tmax1 on Day 1 | NA hours |
| PF-06882961 120mg QD | Time for Cmax (Tmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | Tmax1 on Day 14 or 21 | NA hours |
| PF-06882961 120mg QD | Time for Cmax (Tmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | Tmax2 on Day 14 or 21 | NA hours |
| PF-06882961 120mg QD | Time for Cmax (Tmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | Tmax on Day 1 | 3.00 hours |
| PF-06882961 120mg QD | Time for Cmax (Tmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | Tmax2 on Day 1 | NA hours |
| PF-06882961 120mg QD | Time for Cmax (Tmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | Tmax2 on Day 28 | NA hours |
| PF-06882961 120mg QD | Time for Cmax (Tmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | Tmax on Day 28 | 10.0 hours |
| PF-06882961 120mg QD | Time for Cmax (Tmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28 | Tmax1 on Day 28 | NA hours |