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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04709081 | A Drug Interaction Study of ACH-0145228 | PHASE1 | COMPLETED | 38 | — | — | Dec 22, 2019 | Apr 16, 2020 | Jan 14, 2021 | 1 | United States |
| Arm | Type | Description |
|---|---|---|
| Part 1: ACH-0145228, Midazolam, and Digoxin | EXPERIMENTAL | Period 1: Participants received single doses of midazolam and digoxin. Period 2: Participants received ACH-0145228 twice daily, in addition to coadministration with single doses of midazolam and digoxin. Scheduled pharmacokinetics (PK) blood and urine samples were collected, with a washout period of at least 7 days between collection of the last PK blood sample in Period 1 and the first dose of ACH-0145228 in Period 2. |
| Part 2: ACH-0145228 and Itraconazole | EXPERIMENTAL | Period 1: Participants received a single dose of ACH-0145228. Period 2: Participants received itraconazole once daily, in addition to coadministration with a single dose of ACH-0145228. Scheduled PK blood samples were collected, with a washout period of at least 2 days between collection of the last PK blood sample in Period 1 and the first dose of itraconazole in Period 2. |
| Name | Type | Description |
|---|---|---|
| ACH-0145228 | DRUG | ACH-0145228 was dosed as 2 x 60 milligram (mg) (Part 1) or 1 x 40 mg (Part 2) powder in capsules. |
| Midazolam | DRUG | Midazolam was dosed at 2 mg (1 milliliter \[mL\] of a 2 mg/mL syrup). |
| Digoxin | DRUG | Digoxin was dosed as Lanoxin (or generic equivalent) at 1 x 0.25 mg tablet. |
| Itraconazole | DRUG | Itraconazole was dosed as Sporanox (or generic equivalent) at 200 mg (20 mL of a 10 mg/mL oral solution). |
Inclusion Criteria: 1. Body mass index in the range of 18.0 to 32.0 kilograms (kg)/meter squared, inclusive, with a minimum body weight of 50.0 kg at screening. 2. No clinically significant history or presence of electrocardiogram abnormalities at screening and prior to first dosing in Period 1. 3....