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

NCT05988034 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2023-08-14

No results posted yet for this study

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

DRUG

Avacopan

Administered orally.

DRUG

Moxifloxacin

Administered orally.

DRUG

Placebo for avacopan

Administered orally.

DRUG

Placebo for moxifloxacin

Administered orally.

Sponsors & Collaborators

Principal Investigators

  • MD · Amgen

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-11-08
Primary Completion
2020-01-22
Completion
2020-03-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05988034 on ClinicalTrials.gov