Effect of Repeated Oral Doses of Avacopan on the Pharmacokinetics (PK) of a Single Dose of Simvastatin

NCT06207682 ↗

Phase 1 Completed 32 enrolled Amgen

RandomizedParallel-groupOpen-labelBasic science

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.

Timeline

Start: 2022-06-28
Primary completion: 2022-08-11
Completion: 2022-08-11

Publications

Miao S, Bekker P, Armas D, Lor M, Han Y, Webster K, Trivedi A. Pharmacokinetic Evaluation of the CYP3A4 and CYP2C9 Drug-Drug Interaction of Avacopan in 2 Open-Label Studies in Healthy Participants. Clin Pharmacol Drug Dev. 2024 May;13(5):517-533. doi: 10.1002/cpdd.1389. Epub 2024 Feb 29.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Avacopan	Small molecule	30 mg	Oral
Subject	Avacopan	Small molecule	60 mg	Oral
Subject	Simvastatin	Small molecule	40 mg	Oral

Indications

No indication recorded.