Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02838264 | A Study To Evaluate The Effect Of Itraconazole On Pharmacokinetics Of PF-06463922 In Healthy Volunteers | PHASE1 | COMPLETED | 16 | — | — | Aug 16, 2016 | May 3, 2017 | May 15, 2017 | 1 | Belgium |
| NCT02804399 | A Study To Evaluate The Effect Of Rifampin On Pharmacokinetics Of PF-06463922 In Healthy Volunteers | PHASE1 | COMPLETED | 12 | — | — | Jul 1, 2016 | Oct 1, 2016 | Jan 25, 2019 | 1 | United States |
| NCT02569554 | PPI And Food Effect Study For PF-06463922 In Healthy Volunteers | PHASE1 | COMPLETED | 27 | — | — | Dec 1, 2015 | Apr 1, 2016 | May 17, 2016 | 1 | Belgium |
| NCT02564562 | A Study To Investigate The Absorption, Distribution, Metabolism, And Excretion Of [14c]PF-06463922 In Healthy Male Volunteers | PHASE1 | COMPLETED | 6 | — | — | Oct 1, 2015 | Nov 1, 2015 | Dec 4, 2015 | 1 | United States |
Area under the plasma concentration-time profile from time zero extrapolated to infinite time
Maximum plasma concentration
AUCinf is the plasma area under the plasma concentration-time profile from time 0 extrapolated to infinite time. The pharmacokinetics (PK) parameter analysis population was defined as all participants enrolled and treated who have at least 1 of the PF-06463922 PK parameters of primary interest in at least 1 treatment period.
Cmax is the maximum observed plasma concentration. PK parameter analysis population was defined as all participants enrolled and treated who have at least 1 of the PF-06463922 PK parameters of primary interest in at least 1 treatment period.
area under plasma concentration-time profile from time 0 extrapolated to infinite time for PF-06463922
observed maximal plasma PF-06463922 concentration
Mass balance: Cumulative recovery (%) of total radioactivity in urine and feces.
Area Under the Curve From Time Zero to Extrapolated Infinite Time
Area under the plasma concentration time profile from time 0 to the time of the last quantifiable concentration (Clast)
Elimination rate constant
Maximum observed plasma concentration
Time for Cmax
Terminal elimination half life
Apparent oral clearance
Total amount of unchanged drug excreted in the urine from time 0 to discharge day
Total amount of unchanged drug excreted in the urine from time 0 to infinity expressed as percent of dose
Renal Clearance
Total radioactivity in RBCs
Apparent volume of distribution following oral administration
| Arm | Type | Description |
|---|---|---|
| Cohort 1 | EXPERIMENTAL | All subjects in this cohort will receive the same dose of PF-06463922 in both periods. Subjects will receive PF-06463922 Alone in Period 1 followed by PF-06463922 with Itraconazole in Period 2. |
| Cohort 2 | EXPERIMENTAL | All subjects in this cohort will receive the same dose of PF-06463922 in both periods. Subjects will receive PF-06463922 Alone in Period 1 followed by PF-06463922 with Itraconazole in Period 2. |
| Cohort 3 | EXPERIMENTAL | All subjects in this cohort will receive the same dose of PF-06463922 in both periods. Subjects will receive PF-06463922 Alone in Period 1 followed by PF-06463922 with Itraconazole in Period 2. |
| Cohort 4 | EXPERIMENTAL | All subjects in this cohort will receive the same dose of PF-06463922 in both periods. Subjects will receive the highest safe dose (mg) of PF-06463922 as a single-dose Alone in Period 1 followed by PF-06463922 with Itraconazole in Period 2. |
| all subjects | EXPERIMENTAL | subjects will receive a 100 mg single oral dose of PF-06463922 followed by a 100 mg single dose of PF-06463922 combined with 600 mg QD dose of rifampin with at least 10 days of washout period between two PF-06463922 doses. |
| PF-06463922 | EXPERIMENTAL | each subject will receive four single doses of PF-06463922 without food, with food, with rabeprazole (without food), and one of the two new formulations without food. |
| Treatment | EXPERIMENTAL | Radiolabeled PF-06463922 in healthy volunteers |
| Name | Type | Description |
|---|---|---|
| PF-06463922 | DRUG | Single oral dose of PF-06463922 50 mg on Day 1 of Period 1 and Day 5 of Period 2 |
| Itraconazole | DRUG | 200 mg oral dose of itraconazole on Days 1 to 11 during Period 2 |
| rifampin | DRUG | 600 mg QD from day 1 to day 12 in period 2. |
| rabeprazole | DRUG | 20 mg daily tablets in the evening for 5 days and Pf-06463922 on the morning of day 6 in treatment C. |
| [14C] PF-06463922 | DRUG | Single oral dose of 100mg PF-06463922 + \[14C\] PF-06463922 |
Inclusion Criteria: * Healthy female subjects of non childbearing potential and/or male subjects, who at the time of screening, are between the ages of 18 and 55 years, inclusive. * Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs). Exclusion Criteria: * Evide...