drugset / Trial / NCT04889677
Study of a Single Dose of Danicopan in Healthy Participants
Phase 1
Completed
44 enrolled
Alexion Pharmaceuticals, Inc.
Achillion, a wholly owned subsidiary of Alexion · collab
RandomizedParallel-groupDouble-blindBasic science
Summary
This was a single ascending dose, randomized, double-blind study assessing the safety, tolerability, pharmacokinetics, and pharmacodynamics of danicopan in healthy participants. Four different doses (200 milligrams \[mg\], 600 mg, 1200 mg, 2400 mg) and dose-matched placebo were administered under fasted and fed conditions.
Timeline
- Start
- 2016-02-04
- Primary completion
- 2016-06-21
- Completion
- 2016-06-21
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Danicopan | Small molecule | 200 mg | Oral |
| Subject | Danicopan | Small molecule | 600 mg | Oral |
| Subject | Danicopan | Small molecule | 1200 mg | Oral |
| Subject | Danicopan | Small molecule | 2400 mg | Oral |
Indications
No indication recorded.