Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07314346 | Drug-drug Interaction Study of Bemnifosbuvir/Ruzasvir (BEM/RZR) and Buprenorphine/Naloxone or Methadone | PHASE1 | RECRUITING | 32 | — | — | Jan 7, 2025 | Jun 1, 2026 | Apr 13, 2026 | 3 | United States |
Cmax
Cmax
| Arm | Type | Description |
|---|---|---|
| (n=16) buprenorphine/naloxone + BEM/RZR | EXPERIMENTAL | - |
| (n=16) methadone + BEM/RZR | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Buprenorphine/Naloxone + BEM/RZR | DRUG | Day -5 to Day -1:buprenorphine/naloxone as individualized QD doses up to 24mg/6mg. Day 1 to Day 5:Individualized QD doses of buprenorphine/naloxone. Day 6 to Day 12:Individualized QD doses of buprenorphine/naloxone + BEM 550mg/RZR 180mg QD. Day 13 Individualized QD doses of buprenorphine/naloxone. |
| Methadone +BEM/RZR | DRUG | Day -5 to Day -1:methadone individualized QD doses: 30-150mg. Day 1 to Day 5:Individualized QD does of methadone. Day 6 to Day 12:Individualized QD doses of methadone + BEM 550mg/RZR 180mg QD. Day 13 Individualized QD doses of methadone. |
Inclusion Criteria: * Must agree to use acceptable contraceptive methods through at least 90 days after the last dose of study drug. * Minimum body weight of 50 kg and body mass index (BMI) of 18-32 kg/ m2. * Willing to comply with the study requirements and to provide written informed consent. Ex...