NCT06004934

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

An Open-Label, Phase 1 Study to Evaluate the Single-dose Pharmacokinetics of Avacopan (CCX168) in Male and Female Subjects With Mild or Moderate Hepatic Impairment

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

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.

Conditions

• Hepatic Impairment

Interventions

Type	Name	Description
DRUG	Avacopan	Administered orally.

Timeline

• Start date: 2018-04-17
• Primary completion: 2018-09-18
• Completion: 2018-09-18
• First posted: 2023-08-22
• Last updated: 2023-08-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study