Trials / Completed
CompletedNCT03384186
A Study of Modified Release Formulations of Danicopan in Healthy Adult Participants
A Phase 1 Study to Evaluate the Pharmacokinetic Profile of ACH-0144471 Following Administration of Modified Release Prototype Formulations in Healthy Subjects
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 14 (actual)
- Sponsor
- Alexion Pharmaceuticals, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Accepted
Summary
The purpose of this study was to evaluate and compare the plasma pharmacokinetic profiles of ACH-0144471 (danicopan) in healthy participants after administration of single oral doses of modified release prototype formulations.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Danicopan Modified Release Prototype 1 | Danicopan (400 milligrams \[mg\]) oral tablet. |
| DRUG | Danicopan Modified Release Prototype 2 | Danicopan (400 mg) oral tablet. |
| DRUG | Danicopan Modified Release Prototype 3 | Danicopan (800 mg) oral tablet. |
Timeline
- Start date
- 2017-12-01
- Primary completion
- 2018-03-21
- Completion
- 2018-03-21
- First posted
- 2017-12-27
- Last updated
- 2021-08-20
Locations
1 site across 1 country: United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03384186. Inclusion in this directory is not an endorsement.