Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ACH-0145228 · 1 trial · 1 indication
| 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....
ACH-0145228 is an investigational small molecule being developed by AstraZeneca PLC (AZN). It is currently in Phase 1 clinical development. The drug has been studied in healthy volunteers, and its specific therapeutic indication has not been established.
ACH-0145228 is being developed by AstraZeneca PLC, a multinational pharmaceutical company listed on the stock exchange under the ticker AZN. The drug is currently in Phase 1 clinical development.
ACH-0145228 is in Phase 1 clinical development. It has completed one Phase 1 trial, and it is not yet approved by regulatory authorities. The drug is still in the investigational stage.
ACH-0145228 has been studied in one clinical trial, identified as NCT04709081. This was a Phase 1 drug interaction study conducted in the United States, involving 38 healthy volunteers. The trial has been completed.
ACH-0145228 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. The completed trial, NCT04709081, was a drug interaction study in healthy volunteers, and the drug has not yet progressed to later-stage trials.