Trials / Completed
CompletedNCT03555539
Study of Danicopan in Participants With Hepatic Impairment
A Phase 1, 2-Part, Open-Label, Single-Dose, Parallel Group Study to Determine the Effect of Hepatic Impairment on the Safety, Tolerability, and Pharmacokinetics of ACH-0144471 in Adult Subjects
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 16 (actual)
- Sponsor
- Alexion Pharmaceuticals, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Accepted
Summary
The purpose of this study was to evaluate the safety, tolerability, and pharmacokinetics (PK) of ACH-0144471 (danicopan) in participants with hepatic impairment (HI) as compared to healthy matched participants.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Danicopan | Oral tablet. |
Timeline
- Start date
- 2018-05-01
- Primary completion
- 2018-09-21
- Completion
- 2018-09-21
- First posted
- 2018-06-13
- Last updated
- 2021-08-20
Locations
2 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03555539. Inclusion in this directory is not an endorsement.