Study Complete
Sponsor ID
CL013_168

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

Sponsor ID
CL013_168
Clinicaltrials.gov ID
NCT06004934
EUCTIS ID
N/A
EudraCT ID
N/A

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.

Additional Study Details

Phase
Phase 1
Product
N/A
Type
Interventional
Masking
None (Open Label)
Enrollment
24
Additional Study Details

Protocol Summary

Primary Outcome Measures

Maximum Plasma Concentration (Cmax) of Avacopan

Timeframe: Up to Day 18

Cmax of CCX168-M1

Timeframe: Up to Day 18

Time of Cmax (Tmax) of Avacopan

Timeframe: Up to Day 18

Tmax of CCX168-M1

Timeframe: Up to Day 18

Terminal Phase Rate Constant of Avacopan

Timeframe: Up to Day 18

Terminal Phase Rate Constant of CCX168-M1

Timeframe: Up to Day 18

Apparent Terminal Half-life (t1/2z) of Avacopan

Timeframe: Up to Day 18

t1/2z of CCX168-M1

Timeframe: Up to Day 18

Apparent Oral Clearance (CL/F) of Avacopan

Timeframe: Up to Day 18

CL/F of CCX168-M1

Timeframe: Up to Day 18

Apparent Volume of Distribution (Vz/F) of Avacopan

Timeframe: Up to Day 18

Vz/F of CCX168-M1

Timeframe: Up to Day 18

Area Under the Plasma Concentration-time Curve (AUC) from Time 0 to Time t (time of last quantifiable plasma concentration) (AUClast) of Avacopan

Timeframe: Up to Day 18

AUClast of CCX168-M1

Timeframe: Up to Day 18

AUC from Time 0 to Time 6 Hours Post-dose (AUC0-6h) of Avacopan

Timeframe: Up to Hour 6

AUC0-6h of CCX168-M1

Timeframe: Up to Hour 6

AUC from Time 0 to Time 12 Hours Post-dose (AUC0-12h) of Avacopan

Timeframe: Up to Hour 12

AUC0-12h of CCX168-M1

Timeframe: Up to Hour 12

AUC from Time 0 to Infinity (AUC0-inf) of Avacopan

Timeframe: Up to Day 18

AUC0-inf of CCX168-M1

Timeframe: Up to Day 18

Secondary Outcome Measures

Number of Participants Experiencing Adverse Events

Timeframe: Up to Day 18

Locations

Location
Status
Contact Us
Location
Clinical Pharmacology of Miami, Inc.
Hialeah, Florida, United States, 33014
Status
Completed