Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BMS-791325 · 5 trials · 4 indications
Absolute bioavailability of 150 mg (2x75 mg tablets) BMS-791325 administered orally will be established by calculating the ratio of the dose normalized AUC(INF) of oral dose with that of 100 µg IV infused dose.
| Arm | Type | Description |
|---|---|---|
| Arm 1 - BMS-791325 plus peg-interferon alfa-2a and ribavirin | EXPERIMENTAL | - |
| Arm 2 - BMS-791325 plus peg-interferon alfa-2a and ribavirin | EXPERIMENTAL | - |
| Arm 3 - Placebo plus peg-interferon alfa-2a and ribavirin | PLACEBO_COMPARATOR | - |
| ARM A: BMS-791325 | EXPERIMENTAL | BMS-791325 600 mg tablet orally on 1st and 2nd day, then 900 mg on the 3rd day once a day for 3 days |
| ARM B: Moxifloxacin | ACTIVE_COMPARATOR | Moxifloxacin 400mg tablet orally once on third day |
| ARM C: Placebo matching BMS-791325 | PLACEBO_COMPARATOR | Placebo matching BMS-791325 0 mg tablet orally once daily for 3 days |
| BMS-791325 (oral) and [13C]-BMS-791325 (IV) | EXPERIMENTAL | BMS-791325 single dose tablet orally and \[13C\]-BMS-791325 single dose solution intravenously on specific days |
| Midazolam + BMS-791325 | EXPERIMENTAL | - |
| 1 | EXPERIMENTAL | BMS-791325 (100 mg) or placebo match for (100 mg) |
| 2 | EXPERIMENTAL | BMS-791325 (300 mg) or placebo match for (300 mg) |
| 3 | EXPERIMENTAL | BMS-791325 (900 mg) or placebo match for (900 mg) |
| 4 | EXPERIMENTAL | BMS-791325 (potential dose between 10-800 mg) or placebo match for (10-800 mg) |
| Name | Type | Description |
|---|---|---|
| BMS-791325 | DRUG | Tablets, Oral, 75 mg, twice daily, 4-48 weeks depending on response |
| Placebo | DRUG | Tablets, Oral, 0 mg, twice daily, 4-48 weeks depending on response |
| Peg-interferon alfa-2a | DRUG | Syringe, Subcutaneous Injection, 180 µg, once weekly, 4-48 weeks depending on response |
| Ribavirin | DRUG | Tablets, Oral, 1000 or 1200 mg based on weight, twice daily, 4-48 weeks depending on response |
| Moxifloxacin | DRUG | - |
| Placebo matching BMS-791325 | DRUG | - |
| [13C]-BMS-791325 | DRUG | - |
| Midazolam | DRUG | Syrup, Oral, 5 mg, Single dose, 2 days |
Inclusion Criteria: * Subjects chronically infected with HCV genotype 1 as documented by: positive for anti-HCV antibody, HCV RNA, or a positive HCV genotype test at least 6 months prior to Screening, and positive for HCV RNA and anti-HCV antibody at Screening * HCV RNA ≥ 10\*5\* IU/mL at Screening...
BMS-791325 is an investigational small molecule being developed for the treatment of chronic Hepatitis C and Hepatitis C virus infections. It is in Phase 1 clinical development and has not been approved by regulatory authorities. The drug is being studied in patients with chronic Hepatitis C and in healthy volunteers.
BMS-791325 is being developed by Bristol-Myers Squibb Company, which trades on the New York Stock Exchange under the ticker symbol BMY. The company is conducting clinical trials of this investigational drug for the treatment of Hepatitis C virus infections.
BMS-791325 is in Phase 1 clinical development. It is an investigational drug and has not been approved for any use. All clinical trials for BMS-791325 have been completed, with no active trials currently enrolling participants.
BMS-791325 has completed four Phase 1 clinical trials. These include NCT00664625, a single ascending dose study in HCV infected subjects; NCT00996879, a study of its effect on midazolam pharmacokinetics; NCT02084953, a study of its effect on the ECG QTcF interval; and NCT02112110, a study of its absolute bioavailability.
BMS-791325 is an investigational compound being developed by Bristol-Myers Squibb. It is also known by the code name BMS-791325. No other alternative names have been established for this drug in clinical development.