Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
DCV 3DAA · 3 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 |
| 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 |
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...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Atea Pharmaceuticals, Inc. | AVIR | 2 | PHASE3 | Bemnifosbuvir-Ruzasvir, Sofosbuvir-Velpatasvir |
| Abbott Laboratories | ABT | 2 | - | Undisclosed |
| AbbVie, Inc. | ABBV | 1 | - | Undisclosed |
DCV 3DAA is an investigational small molecule being developed for the treatment of Hepatitis C Infection and Hepatitis C. It is a fixed-dose combination of three antiviral drugs: daclatasvir, asunaprevir, and BMS-791325. The drug is currently in Phase 1 clinical development.
DCV 3DAA is being developed by Bristol-Myers Squibb Company, which trades under the ticker symbol BMY. The company is conducting clinical trials to evaluate the drug's safety and pharmacokinetics in healthy volunteers and patients with Hepatitis C.
DCV 3DAA is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Two Phase 1 trials have been completed, with a total of 65 participants enrolled across the studies.
DCV 3DAA has been studied in two completed Phase 1 trials. NCT02095860 assessed the food effect of the fixed-dose combination in 24 healthy volunteers. NCT02108639 evaluated the effect of renal impairment on drug blood levels in 41 participants with Hepatitis C.
DCV 3DAA is a fixed-dose combination tablet containing three direct-acting antiviral agents: daclatasvir (DCV), asunaprevir (ASV), and BMS-791325. It is not the same as any single component alone, but rather a combination product being developed for Hepatitis C treatment.