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Also known as DCV 3DAA FDC
DCV 3DAA · 4 trials · 2 indications
| Arm | Type | Description |
|---|---|---|
| Cohort 2 | EXPERIMENTAL | Sertraline (50 milligrams each morning) day 1-7, DCV 3DAA FDC + 75 mg BMS-791325 twice daily days 13 to 22, DCV 3DAA FDC + 75 mg BMS-791325 twice daily + Sertraline (50 milligrams each morning) days 23-29 |
| Cohort 1 | EXPERIMENTAL | Escitalopram (10 milligrams each morning) day 1-7, DCV 3DAA FDC + 75 mg BMS-791325 twice daily days 13 to 22, DCV 3DAA FDC + 75 mg BMS-791325 twice daily + Escitalopram (10 milligrams each morning) days 23-29 |
| Treatment A: DCV 3DAA FDC fasted state | EXPERIMENTAL | DCV 3 Direct Acting Antiviral (DAA) Fixed Dose Combination (FDC) tablet by mouth once on specified days in fasted state |
| Treatment B: DCV 3DAA FDC with high-fat meal | EXPERIMENTAL | DCV 3DAA FDC tablet by mouth once on specified days with high-fat meal |
| Treatment C: DCV 3DAA FDC with light meal | EXPERIMENTAL | DCV 3DAA FDC tablet by mouth once on specified days with light meal |
| DCV 3DAA FDC + BMS-791325 | EXPERIMENTAL | Group A to D: DCV 3DAA FDC + BMS-791325 oral tablets on specific days Group E: DCV 3DAA FDC + BMS-791325 oral tablets on specific days |
| Part 1: Methadone + DCV 3DAA FDC + BMS-791325 | EXPERIMENTAL | Methadone 40-120 mg tablet or solution orally once on Day 1 Methadone 40-120 mg tablet or solution orally once daily + DCV 3DAA FDC (Daclatasvir 30 mg/Asunaprevir 200 mg/BMS-791325 75 mg 3 direct-acting antiviral (3DAA) fixed dose combination tablet) orally twice daily + BMS-791325 75 mg tablet orally twice daily on Days 2 through 12 |
| Part 2: Buprenorphine/Naloxone + DCV 3DAA FDC + BMS-791325 | ACTIVE_COMPARATOR | Buprenorphine/Naloxone 8/2 - 24/6 mg tablet or sublingual film orally once on Day 1 Buprenorphine/Naloxone 8/2 - 24/6 mg tablet or sublingual film orally once + DCV 3DAA FDC (Daclatasvir 30 mg/Asunaprevir 200 mg/BMS-791325 75 mg 3DAA fixed dose combination tablet) orally twice daily + BMS-791325 75 mg tablet orally twice daily on Days 2 through 12 |
| Name | Type | Description |
|---|---|---|
| Escitalopram | DRUG | 10 milligrams administered each morning |
| Sertraline | DRUG | 50 milligrams administered each morning |
| DCV 3DAA FDC | DRUG | Fixed dose combination (daclatasvir \[DCV\] 30 milligrams, asunaprevir \[ASV\] 200 milligrams, and BMS-791325 75 milligrams) one tablet administered twice daily |
| BMS-791325 | DRUG | 75 milligrams single-agent film coated oral tablet administered twice daily |
| Methadone | DRUG | - |
| Buprenorphine | DRUG | - |
| Naloxone | DRUG | - |
Inclusion Criteria: 1. Signed Informed Consent Form a) Signed written informed consent must be obtained from the subjects in accordance with requirements of the study center's IRB or IEC before the initiation of any protocol-required procedures. 2. Target Population a) Healthy subjects as d...
Top 1 of 4 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Atea Pharmaceuticals, Inc. | AVIR | 2 | PHASE3 | Bemnifosbuvir-Ruzasvir |
DCV 3DAA is an investigational small molecule fixed dose combination developed by Bristol-Myers Squibb for the treatment of hepatitis C and hepatitis C infection. It combines daclatasvir, asunaprevir and BMS-791325 in a single tablet and has been studied in Phase 1 clinical trials.
DCV 3DAA is being developed for the treatment of hepatitis C and hepatitis C infection. Its clinical program has focused on pharmacokinetic and drug interaction studies in healthy volunteers rather than on efficacy in patients, so it remains an investigational combination rather than an approved hepatitis C therapy.
DCV 3DAA is developed by Bristol-Myers Squibb Company, which trades on the New York Stock Exchange under the ticker BMY. The company is the sponsor of the Phase 1 studies conducted for this fixed dose combination.
DCV 3DAA is in Phase 1 clinical development. All three completed trials were Phase 1 studies, and no active trials are currently listed. It is an investigational product and has not been established as an approved treatment.
DCV 3DAA has been evaluated in completed Phase 1 trials including NCT02175602, a pharmacokinetic study in healthy volunteers; NCT02108639, which assessed renal impairment effects; NCT02095860, a food effect study; and NCT02045693, a drug interaction study with methadone and buprenorphine.
Yes, DCV 3DAA FDC is another name for DCV 3DAA. The FDC suffix stands for fixed dose combination, reflecting that daclatasvir, asunaprevir and BMS-791325 are formulated together in a single tablet. Both names refer to the same Bristol-Myers Squibb hepatitis C asset.