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ACH-0145228: Immediate Release · 1 trial · 1 indication
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...
ACH-0145228 Immediate Release is an investigational small molecule being studied in healthy adult participants. It is not approved for any disease and is in Phase 1 clinical development. The single completed trial assessed the drug when administered as an immediate release tablet versus a powder-in-capsule formulation.
ACH-0145228 Immediate Release is being developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker AZN. The company conducted a Phase 1 clinical trial of this investigational small molecule in healthy volunteers.
ACH-0145228 Immediate Release is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The only trial listed for this drug is a completed Phase 1 study in healthy adult participants.
ACH-0145228 Immediate Release has one completed clinical trial, identified as NCT04551586. The study, titled "A Study to Assess ACH-0145228 When Administered as Immediate Release Tablet Versus Powder-In-Capsule in Healthy Adult Participants," enrolled 28 participants in the United States.
ACH-0145228 Immediate Release is a formulation of the investigational drug ACH-0145228. The clinical trial NCT04551586 specifically assessed the immediate release tablet form compared to a powder-in-capsule form of the same drug, ACH-0145228.