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).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
13
Oral capsules
Floridian Clinical Research, LLC
Miami Lakes, Florida, United States
Orlando Clinical Research Center
Orlando, Florida, United States
Maximum Observed Plasma Concentration (Cmax) of Avacopan
Cmax was obtained using noncompartmental analysis.
Time frame: 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
Cmax was obtained using noncompartmental analysis.
Time frame: 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
AUClast was obtained using noncompartmental analysis.
Time frame: 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
AUClast was obtained using noncompartmental analysis.
Time frame: 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
AUCinf was obtained using noncompartmental analysis.
Time frame: 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
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AUCinf was obtained using noncompartmental analysis.
Time frame: 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
AUC0-48 was obtained using noncompartmental analysis.
Time frame: 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
AUC0-48 was obtained using noncompartmental analysis.
Time frame: 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
CLD determines how much of the drug is removed by hemodialysis.
Time frame: 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
CLD determines how much of the drug is removed by hemodialysis.
Time frame: Group 2, Period 1: 0.5, 1, 2 and 3 hours after start of HD and after end of HD at Day 1
Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs)
An adverse event was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) that was temporally associated with the use of a treatment, combination product, medical device, or procedure. A TEAEs was defined as an AE that started during or after first dose administration or started prior to first dose administration and increased in severity after dosing.
Time frame: From first dose of study drug to end of study (EOS) (up to 36 days)
Number of Participants Who Experienced Serious Adverse Events (SAEs)
A SAE was defined as any untoward medical occurrence that met at least 1 of the following criteria: results in death, is immediately life-threatening, required inpatient hospitalization or prolonged existing hospitalization, persistent or significant incapacity/disability, a congenital abnormality/birth defect, or other medically important serious event.
Time frame: From signing the informed consent form (ICF) to 30 days after EOS (up to 96 days)