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 being developed by Pfizer, Inc. (PFE). It is currently in Phase 1 clinical development. The drug has been studied in healthy volunteers to evaluate its safety, tolerability, and pharmacokinetics.
PF-03716539 is being studied for use in healthy volunteers. It is an investigational drug in Phase 1 clinical development, and its safety, tolerability, and pharmacokinetics have been evaluated in a completed clinical trial.
PF-03716539 is being developed by Pfizer, Inc., a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol PFE. The drug is currently in Phase 1 clinical development.
PF-03716539 is in Phase 1 clinical development. It is an investigational drug, not yet approved by regulatory authorities. A Phase 1 study of the drug has been completed in healthy volunteers.
PF-03716539 has been studied in one completed Phase 1 clinical trial, NCT00783484. This trial evaluated the safety, tolerability, and pharmacokinetics of single oral doses of the drug in healthy adult subjects in Belgium.
PF-03716539 is the drug name used in clinical development. No alternative names have been reported for this investigational small molecule being developed by Pfizer, Inc.