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NCT05988034
A Study to Assess the Effect of Avacopan at Therapeutic and Supratherapeutic Doses on the QT/QTc Interval in Healthy Participants
Phase 1 trial testing Avacopan in Electrocardiography in 58 participants. Completed in 31 March 2020.
22 January 2020
Quick facts
| Lead sponsor | Amgen |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | basic science |
| Enrollment | 58 |
| Start date | 8 November 2019 |
| Primary completion | 22 January 2020 |
| Estimated completion | 31 March 2020 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Avacopan (AVACOPAN) — full drug profile →
- Moxifloxacin (moxifloxacin) — full drug profile →
- Placebo for avacopan — full drug profile →
- Placebo for moxifloxacin — full drug profile →
Conditions studied
- Electrocardiography — all drugs for Electrocardiography →
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):
-
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 -
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:
- PubMed search for NCT05988034
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Avacopan
Trials testing the same drug.
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- NCT06676579 — Avacopan in Crescentic Immunoglobulin A Nephropathy (IgAN) · Phase 2 · recruiting
- NCT06321601 — Study to Evaluate Avacopan in Combination With a Rituximab or Cyclophosphamide-containing Regimen, in Children From 6 Ye · Phase 3 · recruiting
- NCT06468826 — A Study of Avacopan in Participants With Normal Renal Function and Participants With End-Stage Renal Disease (ESRD) · Phase 1 · completed
- NCT06072482 — A Study to Evaluate Avacopan in Participants With ANCA-associated Vasculitis · Phase 4 · recruiting
Other recruiting trials for Electrocardiography
Currently open trials in the same condition.
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Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05988034 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Amgen
- Last refreshed: 14 August 2023
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