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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04784000 | Effect of Carbamazepine on the Pharmacokinetics (PK) of AT-527 | PHASE1 | COMPLETED | 20 | — | — | Mar 1, 2021 | Apr 10, 2021 | Jul 29, 2021 | 1 | Canada |
Maximum plasma concentration (Cmax)
| Arm | Type | Description |
|---|---|---|
| AT-527 550 mg + carbamezepine | EXPERIMENTAL | - |
| AT-527 1100 mg + carbamezepine | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Period 1: AT-527 550 mg | DRUG | AT-527 550 mg tablet (1 x 550 mg tablet, in the morning) on Day 1 |
| Period 2: carbamazepine | DRUG | Carbamazepine 100 mg twice daily (BID) Days 3 to 6, 200 mg BID on Days 9 to 11, 300 mg BID on Days 12 to 25 |
| Period 3: AT-527 550 mg + carbamazepine | DRUG | AT-527 550 mg tablet (1 x 550 mg tablet, in the morning) on Day 26 plus carbamazepine 300 mg BID on Day 26 |
| Period 3: AT-527 1100 mg + carbamazepine | DRUG | AT-527 1100 mg tablet (2 x 550 mg tablets, in the morning) on Day 26 plus carbamazepine 300 mg BID on Day 26 |
Inclusion Criteria: * Must agree to use two methods of birth control from Screening through 90 days after administration of the last dose of study drug * Females must have a negative pregnancy test at Screening and prior to dosing * Minimum body weight of 50 kg and body mass index (BMI) of 18-29 kg...