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

Part of paid clinical trials in Tempe, Arizona.

Sponsor
Amgen
Study ID
NCT05988034
Phase
PHASE1
Status
Completed

Conditions

  • Electrocardiography

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Accepted

Interventions

  • Avacopan — DRUG
    Administered orally.
  • Moxifloxacin — DRUG
    Administered orally.
  • Placebo for avacopan — DRUG
    Administered orally.
  • Placebo for moxifloxacin — DRUG
    Administered orally.

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).

Key Dates

Start date
Nov 8, 2019
Status verified
Jul 2023
Primary completion
Jan 22, 2020
Completion
Mar 31, 2020

Study Design

Enrollment
58 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Cohort 1: Avacopan
    Participants will be randomized to receive multiple doses of avacopan orally twice daily (BID): 30 mg for 7 days and 100 mg for 7 days, for a total of 14 dosing days, and placebo for moxifloxacin on Days 1 and 15.
  • Active Comparator: Cohort 2A: Moxifloxacin/Placebo
    Participants will be randomized to receive moxifloxacin 400 mg orally on Day 1, placebo for avacopan BID on Days 1 to 14, and placebo for moxifloxacin on Day 15.
  • Active Comparator: Cohort 2B: Placebo/Moxifloxacin
    Participants will be randomized to receive placebo for moxifloxacin orally on Day 1, placebo for avacopan BID on Days 1 to 14, and moxifloxacin 400 mg orally on Day 15.

Primary Outcome Measure

Change from Baseline in QTcF [ Time Frame: Day -1 (baseline) and up to Day 14 ]

Locations (1)

FacilityCityStateZIPSite coordinators
CelerionTempeArizona85283-

Find similar trials in Tempe, AZ

By research site
Celerion· Tempe, AZ

Related Studies