Study Complete
Sponsor ID
20230265

A Study of Avacopan in Participants with Normal Renal Function and Participants with End-Stage Renal Disease (ESRD)

Sponsor ID
20230265
Clinicaltrials.gov ID
NCT06468826
EUCTIS ID
N/A
EudraCT ID
N/A

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).

Additional Study Details

Phase
Phase 1
Product
AMG 569
Type
Interventional
Masking
None (Open Label)
Enrollment
13
Additional Study Details

Protocol Summary

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Locations

Location
Status
Contact Us
Location
Orlando Clinical Research Center
Orlando, FL, United States, 32809-3017
Status
Recruiting
Location
Floridian Clinical Research, LLC
Miami Lakes, Florida, United States, 33016
Status
Completed