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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04551586 | A Study to Assess ACH-0145228 When Administered as Immediate Release Tablet Versus Powder-In-Capsule in Healthy Adult Participants | PHASE1 | COMPLETED | 28 | — | — | Jun 26, 2020 | Oct 19, 2020 | Dec 28, 2021 | 1 | United States |
Relative bioavailability will be measured by the ratio of the area under the concentration versus time curve from time 0 extrapolated to infinity (AUC0-inf).
| Arm | Type | Description |
|---|---|---|
| Sequence 1 | EXPERIMENTAL | Participants will receive ACH-0145228 once each Period as a single dose under fasted or fed conditions as follows: Period 1: ACH-0145228 as an immediate-release tablet under fasted conditions (test-fasted). Period 2: ACH-0145228 as an immediate-release tablet under fed conditions (test-fed). Period 3: ACH-0145228 as power-in-capsule under fasted conditions (reference). There will be a washout period of at least 5 days between each ACH-0145228 dosing. |
| Sequence 2 | EXPERIMENTAL | Participants will receive ACH-0145228 once each Period as a single dose under fasted or fed conditions as follows: Period 1: ACH-0145228 as an immediate-release tablet under fed conditions (test-fed). Period 2: ACH-0145228 as power-in-capsule under fasted conditions (reference). Period 3: ACH-0145228 as an immediate-release tablet under fasted conditions (test-fasted). There will be a washout period of at least 5 days between each ACH-0145228 dosing. |
| Sequence 3 | EXPERIMENTAL | Participants will receive ACH-0145228 once each Period as a single dose under fasted or fed conditions as follows: Period 1: ACH-0145228 as power-in-capsule under fasted conditions (reference). Period 2: ACH-0145228 as an immediate-release tablet under fasted conditions (test-fasted). Period 3: ACH-0145228 as an immediate-release tablet under fed conditions (test-fed). There will be a washout period of at least 5 days between each ACH-0145228 dosing. |
| Name | Type | Description |
|---|---|---|
| ACH-0145228: Immediate Release | DRUG | ACH-0145228 (240 milligrams) will be administered orally on Day 1. |
| ACH-0145228: Powder-in-capsule | DRUG | ACH-0145228 (240 milligrams) will be administered orally on Day 1. |
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 findings at screening. 3. Non-sterile male participants must agree t...