Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
PF-03716539 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Cohort 1 | EXPERIMENTAL | PF-03716539 crossover, single dose escalation (doses subject to change). |
| Cohort 2 | EXPERIMENTAL | PF-03716539 crossover, single dose escalation (doses subject to change). |
| Cohort 3 | EXPERIMENTAL | Midazolam-PF-03716539 drug-drug interaction (PF-03716539 doses subject to change). |
| Cohort 4 | EXPERIMENTAL | Darunavir-PF-03716539 drug-drug interaction (PF-03716539 doses subject to change). |
| Cohort 5 | EXPERIMENTAL | Maraviroc-PF-03716539 drug-drug interaction (PF-03716539 doses subject to change). |
| Cohort 6 | EXPERIMENTAL | Maraviroc-PF-03716539 drug-drug interaction (PF-03716539 200 mg). |
| Name | Type | Description |
|---|---|---|
| PF-03716539 | DRUG | PF-03716539 10 mg oral solution, single dose |
| Placebo | OTHER | Placebo for 3 mg, 10 mg and 25 mg of PF-03716539 (single dose) |
| Midazolam | DRUG | Midazolam 1 mg IV, single dose |
| Midazolam + PF-03716539 (100 mg) | DRUG | Midazolam 1 mg IV, single dose plus PF-03716539 100 mg oral solution, single dose |
| Midazolam + PF-03716539 (50 mg) | DRUG | Midazolam 1 mg IV, single dose plus PF-03716539 50 mg oral solution, single dose |
| Darunavir | DRUG | Darunavir 600 mg tablet twice daily for 9 days (Days 1-9) |
| Darunavir + PF-03716539 | DRUG | Darunavir 600 mg tablet, single dose plus PF-03716539 50 mg oral solution, single dose (Day 10) |
| Maraviroc | DRUG | Maraviroc 150 mg tablet once daily for 6 days (Days 1-6) |
| Maraviroc +PF-03716539 | DRUG | Maraviroc 150 mg tablet, single dose plus PF-03716539 100 mg oral solution, single dose (Day 7) |
Inclusion Criteria: Healthy male and/or female subjects between the ages of 18 and 55 years, inclusive. Body Mass Index (BMI) of approximately 18 to 30 kg/m2. Total body weight \>50 kg (110 lbs). Exclusion Criteria: Pregnant or nursing females. females of childbearing potential. Evidence or hist...
PF-03716539 is an investigational small molecule developed by Pfizer, Inc. (ticker: PFE). It has been studied in a Phase 1 clinical trial in healthy adult volunteers. The specific disease or condition it is intended to treat has not been disclosed.
PF-03716539 is being developed by Pfizer, Inc., which trades under the ticker PFE. Pfizer sponsored the Phase 1 study of the compound. No partnership or licensing arrangement for PF-03716539 has been announced.
PF-03716539 is in Phase 1 development. It is an investigational drug and is not approved by the FDA. One Phase 1 trial has been completed, and no trials are currently active.
PF-03716539 has been evaluated in one clinical trial, NCT00783484, titled a study to evaluate the safety, tolerability and pharmacokinetics of single oral doses of PF-03716539 in healthy adult subjects. The Phase 1 trial was completed, enrolled 37 participants, and was conducted in Belgium.
The Phase 1 trial of PF-03716539, NCT00783484, was a controlled, randomized, double-blind study of single oral doses in healthy adult volunteers. It enrolled 37 participants of all sexes, aged 18 years and older, and was conducted in Belgium. The trial has been completed.