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NCT04232345
A Study to Assess the Effect AZD4831 in Japanese and Chinese Healthy Volunteers
Phase 1 trial testing AZD4831 in Heart Failure With Preserved Ejection Fraction (HFpEF) in 32 participants. Completed in 11 March 2021.
11 March 2021
Quick facts
| Lead sponsor | AstraZeneca |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | sequential |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 32 |
| Start date | 16 January 2020 |
| Primary completion | 11 March 2021 |
| Estimated completion | 11 March 2021 |
| Sites | 1 location across United States |
Drugs / interventions tested
- AZD4831 — full drug profile →
- Placebo
Conditions studied
- Heart Failure With Preserved Ejection Fraction (HFpEF) — all drugs for Heart Failure With Preserved Ejection Fraction (HFpEF) →
Sponsor
AstraZeneca — full company profile →
Who can join
Adults 18 to 50, male only, with Heart Failure With Preserved Ejection Fraction (HFpEF). Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This study is randomized, single-blind, placebo-controlled Phase 1 study aimed to assess the safety and efficacy, pharmacokinetics and pharmacodynamics of multiple doses of oral AZD4831 in healthy Japanese and Chinese volunteers
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
-
Redox signaling at the crossroads of human health and disease.
Zuo J, Zhang Z, Luo M, Zhou L, et al · · 2022 · cited 74× · PMID 35386842 · DOI 10.1002/mco2.127 -
Pathological mechanisms and crosstalk among various cell death pathways in cardiac involvement of systemic lupus erythematosus.
Wei J, Wang A, Li B, Li X, et al · · 2024 · cited 8× · PMID 39301029 · DOI 10.3389/fimmu.2024.1452678 -
Population Pharmacokinetics of the Novel Myeloperoxidase Inhibitor Mitiperstat.
Sunnåker M, Leander J, Ericsson H. · · 2026 · PMID 42101107 · DOI 10.1002/prp2.70259 -
Pharmacokinetics and Tolerability of the Novel Myeloperoxidase Inhibitor Mitiperstat in Healthy Japanese and Chinese Volunteers.
Sunnåker M, Bhattacharya C, Nelander K, Aurell M, et al · · 2024 · PMID 39495467 · DOI 10.1007/s40261-024-01402-x
Verify or expand the search:
- PubMed search for NCT04232345
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of AZD4831
Trials testing the same drug.
- NCT05638737 — A Study in Participants With Non-cirrhotic NASH With Fibrosis · Phase 2 · completed
- NCT05457270 — A Study to Assess the Relative Bioavailability and Safety of Different Formulations of AZD4831 in Fasted State in Health · Phase 1 · completed
- NCT05236543 — A Study to Assess the Pharmacokinetics of AZD4831 When Administered Alone and in Combination With Itraconazole · Phase 1 · completed
- NCT04949438 — A Study to Assess the Pharmacokinetics (Uptake of Drugs by the Body), Safety and Tolerability of AZD4831 in Participants · Phase 1 · completed
- NCT05052710 — Study to Assess the Effect of AZD4831 on the Pharmacokinetics (Drug Behavior in the Body) of Midazolam · Phase 1 · completed
Other recruiting trials for Heart Failure With Preserved Ejection Fraction (HFpEF)
Currently open trials in the same condition.
- NCT06560762 — Study in Participants With Heart Failure With Preserved Ejection Fraction (HFpEF) · Phase 1 · recruiting
- NCT05441839 — UK Heart Failure With Preserved Ejection Fraction · recruiting
- NCT04822649 — Exercise Capacity According to Coronary Microvascular Dysfunction and Body Composition · NA · recruiting
- NCT03876223 — Women's Ischemia Syndrome Evaluation (WISE) Pre-HFpEF · recruiting
Other AstraZeneca trials
Trials by the same sponsor.
- NCT06998095 — Tezepelumab (Tezspire) Regulatory Postmarketing Surveillance in Korea · not yet recruiting
- NCT07431775 — Saphnelo Use in Females of Child-bearing Potential · not yet recruiting
- NCT07516184 — Explore the Diagnostic Value of Bronchodilation Test With Portable Oscillometry in Asthma Diagnosis · NA · not yet recruiting
- NCT07279935 — Osimertinib Combined With Chemotherapy in Patients Who Had Distant Recurrence After Adjuvant Osimertinib for EGFRm Resec · Phase 4 · not yet recruiting
- NCT07279948 — A Single-arm Observational Study to Characterize the Demographic, Clinical Features and Outcomes of a Brazilian Cohort o · not yet recruiting
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 NCT04232345 (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 AstraZeneca
- Last refreshed: 1 April 2021
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/NCT04232345.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing