Trials / Completed
CompletedNCT06207682
Effect of Repeated Oral Doses of Avacopan on the Pharmacokinetics (PK) of a Single Dose of Simvastatin
An Open-Label, Phase 1 Study to Evaluate the Effect of Repeated Oral Doses of Avacopan on the Pharmacokinetics of a Single Dose of Simvastatin in Healthy Volunteers
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 32 (actual)
- Sponsor
- Amgen · Industry
- Sex
- All
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Accepted
Summary
The primary objective of this clinical study is to evaluate the effect of repeated oral doses of avacopan (30 mg and 60 mg twice daily approximately 12 hours apart \[BID\]) given under fed conditions on the PK of a single dose of simvastatin (40 mg) in healthy volunteers.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Avacopan | Orally via capsules |
| DRUG | Simvastatin | Orally via tablets |
Timeline
- Start date
- 2022-06-28
- Primary completion
- 2022-08-11
- Completion
- 2022-08-11
- First posted
- 2024-01-17
- Last updated
- 2024-01-17
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06207682. Inclusion in this directory is not an endorsement.