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).
Age range
18 Years – 75 Years
Sex
ALL
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A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Maximum Observed Plasma Concentration (Cmax) of Avacopan
Timeframe: Group 1, Period 1: predose, 0.25,0.5,1,2,3,4,6,9,12,16,24,36 hours, Days 3,4,5,6,7,8,12,15, and 18 postdose; Group 2, Periods 1 and 2: predose, 0.25,0.5,1,2,3,4,6,9,12,16,24,36 hours, Days 3,4,5,6,7,8,12,15, and 18 postdose
Cmax of Metabolite M1
Timeframe: Group 1, Period 1: predose, 0.25,0.5,1,2,3,4,6,9,12,16,24,36 hours, Days 3,4,5,6,7,8,12,15, and 18 postdose; Group 2, Periods 1 and 2: predose, 0.25,0.5,1,2,3,4,6,9,12,16,24,36 hours, Days 3,4,5,6,7,8,12,15, and 18 postdose
Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to Time of Last Quantifiable Concentration (AUClast) of Avacopan
Timeframe: Group 1, Period 1: predose, 0.25,0.5,1,2,3,4,6,9,12,16,24,36 hours, Days 3,4,5,6,7,8,12,15, and 18 postdose; Group 2, Periods 1 and 2: predose, 0.25,0.5,1,2,3,4,6,9,12,16,24,36 hours, Days 3,4,5,6,7,8,12,15, and 18 postdose
AUClast of Metabolite M1
Timeframe: Group 1, Period 1: predose, 0.25,0.5,1,2,3,4,6,9,12,16,24,36 hours, Days 3,4,5,6,7,8,12,15, and 18 postdose; Group 2, Periods 1 and 2: predose, 0.25,0.5,1,2,3,4,6,9,12,16,24,36 hours, Days 3,4,5,6,7,8,12,15, and 18 postdose
AUC From Time Zero to Infinity (AUCinf) of Avacopan
Timeframe: Group 1, Period 1: predose, 0.25,0.5,1,2,3,4,6,9,12,16,24,36 hours, Days 3,4,5,6,7,8,12,15, and 18 postdose; Group 2, Periods 1 and 2: predose, 0.25,0.5,1,2,3,4,6,9,12,16,24,36 hours, Days 3,4,5,6,7,8,12,15, and 18 postdose
AUCinf of Metabolite M1
Timeframe: Group 1, Period 1: predose, 0.25,0.5,1,2,3,4,6,9,12,16,24,36 hours, Days 3,4,5,6,7,8,12,15, and 18 postdose; Group 2, Periods 1 and 2: predose, 0.25,0.5,1,2,3,4,6,9,12,16,24,36 hours, Days 3,4,5,6,7,8,12,15, and 18 postdose
AUC From Time Zero to 48 Hours (AUC0-48) of Avacopan
Timeframe: Group 1, Period 1: predose, 0.25,0.5,1,2,3,4,6,9,12,16,24,36, and 48 hours postdose; Group 2, Periods 1 and 2: predose, 0.25,0.5,1,2,3,4,6,9,12,16,24,36, and 48 hours postdose
AUC0-48 of Metabolite M1
Timeframe: Group 1, Period 1: predose, 0.25,0.5,1,2,3,4,6,9,12,16,24,36, and 48 hours postdose; Group 2, Periods 1 and 2: predose, 0.25,0.5,1,2,3,4,6,9,12,16,24,36, and 48 hours postdose
Dialysate Clearance (CLD) of Avacopan
Timeframe: Group 2, Period 1: 0.5, 1, 2 and 3 hours after start of HD and after end of HD at Day 1
CLD of Metabolite M1
Timeframe: Group 2, Period 1: 0.5, 1, 2 and 3 hours after start of HD and after end of HD at Day 1