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Also known as ALXN2040, ACH-0144471 (formerly), ACH-4471
Danicopan Modified Release Prototype 1 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Danicopan Modified Release Prototype Tablets | EXPERIMENTAL | Participants received danicopan once each period as a single oral dose as follows: Period 1: Danicopan Modified Release Prototype 1 under fasted conditions. Period 2: Danicopan Modified Release Prototype 2 under fasted conditions. Period 3: Danicopan Modified Release Prototype 3 under fasted conditions. Period 4: Danicopan Modified Release Prototype 2 under fed conditions. There was a washout period of at least 14 days between each danicopan dosing. |
| Name | Type | Description |
|---|---|---|
| Danicopan Modified Release Prototype 1 | DRUG | Danicopan (400 milligrams \[mg\]) oral tablet. |
| Danicopan Modified Release Prototype 2 | DRUG | Danicopan (400 mg) oral tablet. |
| Danicopan Modified Release Prototype 3 | DRUG | Danicopan (800 mg) oral tablet. |
Inclusion Criteria: * Body mass index of 18.0 to 30.0 kilograms/square meter. * Female participants of childbearing potential must either agree to abstinence or use of a highly effective method of contraception. * Male participants must either agree to abstinence or use of a condom plus an effectiv...
Danicopan Modified Release Prototype 1 is an investigational small molecule developed by AstraZeneca PLC (ticker AZN). It is a modified release formulation of danicopan studied in healthy adult volunteers. The program is in Phase 1 clinical development, and the specific therapeutic indication has not been disclosed.
Danicopan Modified Release Prototype 1 targets complement factor D (CFD) and acts as an inhibitor of that enzyme. By inhibiting CFD, the drug is designed to modulate the complement system. The molecular target is CFD, and the compound is classified as a small molecule inhibitor.
Danicopan Modified Release Prototype 1 is being developed by AstraZeneca PLC, which trades under the ticker AZN. AstraZeneca is the sponsor of the clinical program for this modified release formulation of danicopan.
Danicopan Modified Release Prototype 1 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. The Phase 1 program consists of one completed trial evaluating modified release formulations in healthy adult participants.
Danicopan Modified Release Prototype 1 has been studied in one Phase 1 trial, NCT03384186, titled A Study of Modified Release Formulations of Danicopan in Healthy Adult Participants. The trial was completed, enrolled 14 healthy adult volunteers in the United Kingdom, and was an uncontrolled study.