NCT05988034

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

A Multiple-dose, Randomized, Double-blind, Placebo-controlled, Active-Comparator, Parallel Study to Investigate the Effect of Avacopan at Therapeutic and Supratherapeutic Doses on the QT/QTc Interval in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 58 (actual)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

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).

Conditions

• Electrocardiography

Interventions

Type	Name	Description
DRUG	Avacopan	Administered orally.
DRUG	Moxifloxacin	Administered orally.
DRUG	Placebo for avacopan	Administered orally.
DRUG	Placebo for moxifloxacin	Administered orally.

Timeline

• Start date: 2019-11-08
• Primary completion: 2020-01-22
• Completion: 2020-03-31
• First posted: 2023-08-14
• Last updated: 2023-08-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study