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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02883114 | An Open-Label, 2 Treatment Period,Study To Study The Drug Interaction Between Repeated Doses Of Itraconazole And Single Dose Pharmacokinetics (PK) Of PF-06648671 In Healthy Adults. | PHASE1 | COMPLETED | 12 | — | — | Sep 1, 2016 | Nov 1, 2016 | Dec 20, 2016 | 1 | United States |
Camx after single dose of 25 mg PF-06648671 in period 1 and period 2
Tmax following single doses of PF-06648671 in period 1 and period 2
AUCinf following single doses of PF-06648671 in period 1 and period 2
AUClast following single doses of PF-06648671 in period 1 and period 2
t1/2 following single doses of PF-06648671 in period 1 and period 2
CL/F following single doses of PF-06648671 in period 1 and period 2
Vz/F following single doses of PF-06648671 in period 1 and period 2
| Arm | Type | Description |
|---|---|---|
| single cohort | EXPERIMENTAL | single dose of PF-06648671 in period 1 and 14-day dose of itraconazole plus single dose of PF-06648671 in period 2 |
| Name | Type | Description |
|---|---|---|
| PF-06648671 | DRUG | Subjects will receive a single dose of PF-06648671 25 mg oral suspension on day 1 in period 1 and a single dose on Day 4 in period 2. |
| Itraconazole | DRUG | Subjects will receive itraconazole 200 mg oral solution once a day for 14 days in period 2 |
Inclusion Criteria: 1. Healthy male and/or female subjects of non childbearing potential between the ages of 18 and 55 years at the time of screening, inclusive. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including...