Study Complete
Sponsor ID
CL014_168

A Study to Assess the Effect of Avacopan at Therapeutic and Supratherapeutic Doses on the QT/QTc Interval in Healthy Participants

Sponsor ID
CL014_168
Clinicaltrials.gov ID
NCT05988034
EUCTIS ID
N/A
EudraCT ID
N/A

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).

Additional Study Details

Phase
Phase 1
Product
N/A
Type
Interventional
Masking
Double (Participant, Investigator)
Enrollment
58
Additional Study Details

Protocol Summary

Primary Outcome Measures

Change from Baseline in QTcF

Timeframe: Day -1 (baseline) and up to Day 14

Secondary Outcome Measures

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

Locations

Location
Status
Contact Us
Location
Celerion
Tempe, Arizona, United States, 85283
Status
Completed