A Study of Avacopan in Participants with Normal Renal Function and Participants with End-Stage Renal Disease (ESRD)
Study Details
The primary objective of the study is to evaluate the pharmacokinetics (PK) of avacopan and metabolite (M1) after a single dose of avacopan in participants with normal renal function and participants with ESRD requiring hemodialysis (HD).
Protocol Summary
Maximum Observed Plasma Concentration (Cmax) of Avacopan
Timeframe: Predose, 0.25, 0.5, 1, 2, 3, 4, 6, 9, 12, 16, 24, 36 hours (postdose), Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 12, Day 15, and Day 18.
Cmax of M1
Timeframe: Predose, 0.25, 0.5, 1, 2, 3, 4, 6, 9, 12, 16, 24, 36 hours (postdose), Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 12, Day 15, and Day 18.
Area Under the Plasma Concentration-time Curve (AUC) from Time Zero to Time of Last Quantifiable Concentration (AUClast) of Avacopan
Timeframe: Predose, 0.25, 0.5, 1, 2, 3, 4, 6, 9, 12, 16, 24, 36 hours (postdose), Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 12, Day 15, and Day 18.
AUClast of M1
Timeframe: Predose, 0.25, 0.5, 1, 2, 3, 4, 6, 9, 12, 16, 24, 36 hours (postdose), Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 12, Day 15, and Day 18.
AUC from Time Zero to Infinity (AUCinf) of Avacopan
Timeframe: Predose, 0.25, 0.5, 1, 2, 3, 4, 6, 9, 12, 16, 24, 36 hours (postdose), Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 12, Day 15, and Day 18.
AUCinf of M1
Timeframe: Predose, 0.25, 0.5, 1, 2, 3, 4, 6, 9, 12, 16, 24, 36 hours (postdose), Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 12, Day 15, and Day 18.
AUC from Time Zero to 48 Hours (AUC0-48) of Avacopan
Timeframe: Predose, 0.25, 0.5, 1, 2, 3, 4, 6, 9, 12, 16, 24, 36 hours (postdose), Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 12, Day 15, and Day 18.
AUC0-48 of M1
Timeframe: Predose, 0.25, 0.5, 1, 2, 3, 4, 6, 9, 12, 16, 24, 36 hours (postdose), Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 12, Day 15, and Day 18.
HD Clearance of Drug Dialysate (CLD) of Avacopan
Timeframe: Predose, 0.25, 0.5, 1, 2, 3, 4, 6, 9, 12, 16, 24, 36 hours (postdose), Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 12, Day 15, and Day 18.
HD CLD of M1
Timeframe: Predose, 0.25, 0.5, 1, 2, 3, 4, 6, 9, 12, 16, 24, 36 hours (postdose), Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 12, Day 15, and Day 18.
Number of Participants who Experienced Treatment-emergent Adverse Events
Timeframe: Up to approximately 37 days.
Number of Participants who Experienced Serious Adverse Events
Timeframe: Up to approximately 96 days.