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

Phase 1

Completed

• Conditions: End-Stage Renal Disease (ESRD)
• Interventions: Drug: Avacopan

• Registration Number: NCT06468826
• Lead Sponsor: Amgen

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-06-17
• Study First Submitted QC: 2024-06-17
• Study First Posted: 2024-06-21
• Study Start: 2024-07-11
• Status Verified: 2024-10
• Primary Completion: 2024-10-05
• Study Completion: 2024-10-05
• Last Update Submitted: 2024-10-14
• Last Update Posted: 2024-10-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 2: ESRD Requiring HD	Avacopan	Participants in Group 2 will receive a single dose of avacopan on Day 1 in each of 2 treatment periods (Period 1/on HD and Period 2/off HD).
Group 1: Normal Renal Function	Avacopan	Participants in Group 1 will receive a single dose of avacopan on Day 1.

Primary Outcome Measures

Name	Time	Method
Cmax of M1	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	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.
Maximum Observed Plasma Concentration (Cmax) of Avacopan	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	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	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	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	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	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	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 From Plasma (CLD) of Avacopan	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

Name	Time	Method
Number of Participants who Experienced Serious Adverse Events	Up to approximately 96 days.
Number of Participants who Experienced Treatment-emergent Adverse Events	Up to approximately 37 days.

Trial Locations

Locations (2)

Floridian Clinical Research, LLC; 🇺🇸 Miami Lakes, Florida, United States

Orlando Clinical Research Center; 🇺🇸 Orlando, Florida, United States