A Study to Assess the Effect of Avacopan at Therapeutic and Supratherapeutic Doses on the QT/QTc Interval in Healthy Participants
Study Details
The primary objective of this study is to evaluate the effects of therapeutic and supratherapeutic doses of avacopan on the heart rate corrected QT interval, using Fridericia's formula (QTcF).
Protocol Summary
Change from Baseline in QTcF
Timeframe: Day -1 (baseline) and up to Day 14
Change from Baseline in Heart Rate (HR)
Timeframe: Day -1 (baseline) and Days 1, 7, and 14
Change from Baseline in Time Between P and R Wave (PR Interval)
Timeframe: Day -1 (baseline) and Days 1, 7, and 14
Change from Baseline in Complex Between Q and S Wave (QRS Interval)
Timeframe: Day -1 (baseline) and Days 1, 7, and 14
Placebo-corrected Change from Baseline in HR
Timeframe: Day -1 (baseline) and Days 1, 7, and 14
Placebo-corrected Change from Baseline in QTcF
Timeframe: Day -1 (baseline) and Days 1, 7, and 14
Placebo-corrected Change from Baseline in PR Interval
Timeframe: Day -1 (baseline) and Days 1, 7, and 14
Placebo-corrected Change from Baseline in QRS Interval
Timeframe: Day -1 (baseline) and Days 1, 7, and 14
Number of Participants with Categorical Increases in QTcF from Baseline
Timeframe: Day -1 (baseline) and Days 1, 7, and 14
Number of Participants with Categorical Increases in PR Interval from Baseline
Timeframe: Day -1 (baseline) and Days 1, 7, and 14
Number of Participants with Categorical Increases in QRS Interval from Baseline
Timeframe: Day -1 (baseline) and Days 1, 7, and 14
Number of Participants with Categorical Decreases in HR from Baseline
Timeframe: Day -1 (baseline) and Days 1, 7, and 14
Change from Baseline in the Number of T-wave Morphology Findings
Timeframe: Day -1 (baseline) and Days 1, 7, and 14
Change from Baseline in the Number of U-waves
Timeframe: Day -1 (baseline) and Days 1, 7, and 14
Maximum Observed Plasma Concentration (Cmax) of Avacopan
Timeframe: Up to Day 14
Cmax of Avacopan Metabolite M1
Timeframe: Up to Day 14
Time of Cmax (Tmax) of Avacopan
Timeframe: Up to Day 14
Tmax of Avacopan Metabolite M1
Timeframe: Up to Day 14
Area Under the Plasma Concentration-time Curve (AUC) From Time 0 to 6 Hours (AUC0-6h) of Avacopan
Timeframe: Up to Hour 6 post-dose on Days 1, 7, and 14
AUC0-6h of Avacopan Metabolite M1
Timeframe: Up to Hour 6 post-dose on Days 1, 7, and 14
AUC From Time 0 to 12 Hours (AUC0-12h) of Avacopan
Timeframe: Up to Hour 12 post-dose on Days 1, 7, and 14
AUC0-12h of Avacopan Metabolite M1
Timeframe: Up to Hour 12 post-dose on Days 1, 7, and 14