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

Phase 1 Completed 58 enrolled Amgen

RandomizedParallel-groupDouble-blindBasic science

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).

Timeline

Start: 2019-11-08
Primary completion: 2020-01-22
Completion: 2020-03-31

Outcome

Met primary endpoint

paper Based on the C-QTc analysis, avacopan's effect on ΔΔQTcF >10 ms can be excluded within the observed plasma concentration range PMID 38973157 ↗

Publications

Miao S, Staehr P, Tai E, Darpo B, Xue H, Armas D, Webster K, Oberoi RK. A phase I thorough QT/QTc study evaluating therapeutic and supratherapeutic doses of avacopan in healthy participants. Clin Transl Sci. 2024 Jul;17(7):e13878. doi: 10.1111/cts.13878.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Avacopan	Small molecule	30 mg	Oral
Subject	Avacopan	Small molecule	100 mg	Oral
Comparator	Moxifloxacin	Small molecule	400 mg	Oral

Indications

No indication recorded.