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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, hepatitis C virus infection, and hepatitis C. It has been studied in patients with these conditions as well as in healthy subjects for drug interaction and safety assessments.
BMS-791325 is being developed by Bristol-Myers Squibb Company, a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol BMY. The company has conducted clinical trials of BMS-791325 in the United States and Argentina.
BMS-791325 has completed Phase 1 and Phase 2 clinical trials. It is an investigational drug and has not been approved by the FDA. Its development status is based on completed trials, with no active trials currently listed.
BMS-791325 has been studied in several completed trials. NCT00664625 was a single ascending dose study in HCV-infected subjects. NCT00996879 assessed its effect on midazolam pharmacokinetics in healthy subjects. NCT01193361 was a Phase 2 study of standard of care with or without BMS-791325. NCT02084953 evaluated its effect on the ECG QTcF interval.
BMS-791325 is the primary name used in clinical trial records for this investigational compound. No alternative names have been associated with it in the available trial information, so it is not known to be the same as any other marketed drug.