Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
HCV-796 · 5 trials · 3 indications
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | HCV-796 1000mg single dose |
| Name | Type | Description |
|---|---|---|
| HCV-796 | DRUG | - |
| midazolam | DRUG | - |
| Desipramine | DRUG | Period 1: Single oral dose of desipramine (50 mg) on day 1. No test article administration on days 2 to 6. Period 2: Multiple oral doses of HCV-796 (500 mg) every 12 hours on days 1 to 9. Period 3: Multiple oral doses of HCV-796 (500 mg) every 12 hours on days 10 to 14 and a single oral dose of desipramine (50 mg) on day 10. |
Inclusion Criteria: * Healthy as determined by investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs and 12-lead ECG.
HCV-796 is an investigational small molecule being studied for use in hepatitis C. It has been evaluated in healthy volunteers in Phase 1 clinical trials to assess its pharmacokinetics, safety, and tolerability. The drug is not approved and remains in clinical development.
HCV-796 is being developed by Pfizer, Inc., which trades under the ticker PFE. The company has sponsored Phase 1 clinical trials of the drug in healthy volunteers.
HCV-796 is in Phase 1 clinical development. All four completed trials were Phase 1 studies conducted in healthy volunteers. The drug is investigational and has not been approved by regulatory authorities.
HCV-796 has been studied in four completed Phase 1 trials: NCT00385190 in healthy Japanese men, NCT00407173 evaluating age and gender effects, NCT00410254 studying interaction with midazolam, and NCT00500721 studying interaction with desipramine. All trials enrolled healthy volunteers.
HCV-796 is not FDA approved. It is an investigational drug that has only been studied in Phase 1 clinical trials in healthy volunteers. Its safety and efficacy have not been established for any condition.