A Study to Evaluate the Pharmacokinetics of Avacopan (CCX168) in Participants With Mild or Moderate Hepatic Impairment

Phase 1 Completed 24 enrolled Amgen

Non-randomizedParallel-groupOpen-labelTreatment

Summary

The primary objective of this study will be to evaluate the pharmacokinetic properties of avacopan and its metabolite CCX168-M1 after a single oral dose of 30 mg avacopan in participants with mild or moderate hepatic impairment compared to matched healthy controls.

Timeline

Start: 2018-04-17
Primary completion: 2018-09-18
Completion: 2018-09-18

Publications

Miao S, Suso P, Furst JA, Hudson MG, Trivedi A. Effect of Mild or Moderate Hepatic Impairment on the Pharmacokinetics of Avacopan, a Small-Molecule Complement C5a Receptor Antagonist, for the Treatment of Antineutrophil Cytoplasmic Autoantibody-Associated Vasculitis. Clin Pharmacol Drug Dev. 2024 Sep;13(9):1000-1010. doi: 10.1002/cpdd.1444. Epub 2024 Jul 11.

Drugs

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

Indications

No indication recorded.