Last reviewed · How we verify

NCT05988034

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

Completed Phase 1 Last updated 14 August 2023
What this trial tests

Phase 1 trial testing Avacopan in Electrocardiography in 58 participants. Completed in 31 March 2020.

Timeline
8 November 2019
Primary endpoint
22 January 2020
31 March 2020

Quick facts

Lead sponsorAmgen
PhasePhase 1
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposebasic science
Enrollment58
Start date8 November 2019
Primary completion22 January 2020
Estimated completion31 March 2020
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Amgen — full company profile →

Who can join

Adults 18 to 60, any sex, with Electrocardiography. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. A phase I thorough QT/QTc study evaluating therapeutic and supratherapeutic doses of avacopan in healthy participants.
    Miao S, Staehr P, Tai E, Darpo B, et al · · 2024 · cited 4× · PMID 38973157 · DOI 10.1111/cts.13878
  2. Functional Roles of the Complement Immune System in Cardiac Inflammation and Hypertrophy.
    Hok KD, Rich HE, Shadid A, Gunamalai L, et al · · 2025 · cited 2× · PMID 41155225 · DOI 10.3390/ijms26209931

Verify or expand the search:

Other trials of Avacopan

Trials testing the same drug.

Other recruiting trials for Electrocardiography

Currently open trials in the same condition.

Other Amgen trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05988034.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing