Trials / Completed
CompletedNCT04889391
Study of Radiolabeled Danicopan in Healthy Male Participants
A Phase I, Open-Label, Single Dose ADME Study of 14C-ACH-0144471 in Healthy Male Subjects
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 8 (actual)
- Sponsor
- Alexion Pharmaceuticals, Inc. · Industry
- Sex
- Male
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Accepted
Summary
This was an open-label study to evaluate the absorption, distribution, metabolism, and excretion of radioactivity in healthy male participants following a single 150-milligram (mg) oral dose of carbon-14 (\[14C\])-ACH-014447 (\[14C\])-danicopan) containing approximately 100 microcuries (µCi) of \[14C\].
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | [14C]-Danicopan | Liquid-filled capsules. |
Timeline
- Start date
- 2017-09-14
- Primary completion
- 2017-10-15
- Completion
- 2017-10-15
- First posted
- 2021-05-17
- Last updated
- 2021-05-17
Locations
1 site across 1 country: New Zealand
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04889391. Inclusion in this directory is not an endorsement.