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

Conditions

• Hepatic Impairment

Eligibility Criteria

Sex

ALL

Age

18 Years - 75 Years

Healthy Volunteers

Accepted

Interventions

• Avacopan — DRUG
  Administered orally.

Study Details

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.

Key Dates

Start date

Apr 17, 2018

Status verified

Jul 2023

Primary completion

Sep 18, 2018

Completion

Sep 18, 2018

Study Design

Enrollment

24 participants (actual)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Group 1: Mild Hepatic Impairment
  Participants with mild hepatic impairment (defined using Child-Pugh Classification of the Severity of Liver Disease \[C-P\] criteria \[C-P Class A, score of 5 to 6 points\]) will receive a single oral dose of 30 mg avacopan on Day 1 in the fasted state.
• Experimental: Group 2: Moderate Hepatic Impairment
  Participants with moderate hepatic impairment (defined using the C-P criteria \[C-P Class B, score of 7 to 9 points\]) will receive a single oral dose of 30 mg avacopan on Day 1 in the fasted state.
• Active Comparator: Group 3: Healthy Control Group
  Participants with normal hepatic function (medically normal with no clinically significant illness or disease or abnormal physical examination findings, and with normal laboratory values at screening) will be demographically-matched to participants in Group 1 and Group 2, and will receive a single oral dose of 30 mg avacopan on Day 1 in the fasted state.

Primary Outcome Measure

Maximum Plasma Concentration (Cmax) of Avacopan [ Time Frame: Up to Day 18 ]

Locations (1)

Find similar trials in Hialeah, FL

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