A Study to Evaluate the Pharmacokinetics of Avacopan (CCX168) in Participants with Mild or Moderate Hepatic Impairment
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.
Protocol Summary
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
Number of Participants Experiencing Adverse Events
Timeframe: Up to Day 18