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Clinical Trial Details

Trial ID: L0662
Source ID: NCT06468826
Associated Drug: Avacopan
Title: A Study of Avacopan in Participants With Normal Renal Function and Participants With End-Stage Renal Disease (ESRD)
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: End-Stage Renal Disease (ESRD)
Interventions: DRUG: Avacopan
Outcome Measures: Primary: 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.|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.|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.|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.|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.|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.|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.|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 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.|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. | Secondary: Number of Participants who Experienced Treatment-emergent Adverse Events, Up to approximately 37 days.|Number of Participants who Experienced Serious Adverse Events, Up to approximately 96 days.
Sponsor/Collaborators: Sponsor: Amgen
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE1
Enrollment: 13
Study Type: INTERVENTIONAL
Study Designs: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-07-11
Completion Date: 2024-10-05
Results First Posted:
Last Update Posted: 2024-10-15
Locations: Floridian Clinical Research, LLC, Miami Lakes, Florida, 33016, United States|Orlando Clinical Research Center, Orlando, Florida, 32809-3017, United States
URL: https://clinicaltrials.gov/show/NCT06468826

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress