Last reviewed · How we verify
NCT03843060
A Phase 1 Study to Assess the Pharmacokinetics of AZD9977 Administered Alone and in Combination With Itraconazole in Healthy Volunteers
Phase 1 trial testing AZD9977 in Heart Failure With Preserved Ejection Fraction (HFpEF) in 14 participants. Completed in 1 April 2019.
1 April 2019
Quick facts
| Lead sponsor | AstraZeneca |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | sequential |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 14 |
| Start date | 22 February 2019 |
| Primary completion | 1 April 2019 |
| Estimated completion | 1 April 2019 |
| Sites | 1 location across United States |
Drugs / interventions tested
- AZD9977 — full drug profile →
- Itraconazole — full drug profile →
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 55, any sex, with Heart Failure With Preserved Ejection Fraction (HFpEF). Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is an open-label, non-randomized, fixed sequence study conducted at a single study center with primary aim to assess the pharmacokinetics (PK) of AZD9977 in healthy volunteers when administered alone and in combination with multiple doses of itraconazole.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
Novel therapeutics for the treatment of hypertension and its associated complications: peptide- and nonpeptide-based strategies.
Ghatage T, Goyal SG, Dhar A, Bhat A. · · 2021 · cited 54× · PMID 33731923 · DOI 10.1038/s41440-021-00643-z -
Concentration-QT modeling demonstrates that the selective mineralocorticoid receptor modulator, balcinrenone (AZD9977), does not prolong QT interval.
Sundell J, Rekic D, Melin J, Johansson S, et al · · 2025 · cited 1× · PMID 39497618 · DOI 10.1002/psp4.13272 -
Population Pharmacokinetic Analysis of Balcinrenone in Healthy Participants and Participants with Heart Failure and Chronic Kidney Disease.
Parkinson J, Åstrand M, Melin J, Ericsson H. · · 2025 · PMID 40965596 · DOI 10.1007/s40262-025-01572-7
Verify or expand the search:
- PubMed search for NCT03843060
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of AZD9977
Trials testing the same drug.
- NCT04595370 — Efficacy, Safety and Tolerability of AZD9977 and Dapagliflozin in Participants With Heart Failure and Chronic Kidney Dis · Phase 2 · completed
- NCT04469907 — Study to Assess the Pharmacokinetics and Safety of AZD9977 in Participants With Renal Impairment · Phase 1 · completed
- NCT03801967 — A Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD9977 in Japanese Healthy Participants With Single · Phase 1 · completed
- NCT03682497 — Study in HFpEF Patients to Compare the Effect of AZD9977 and Spironolactone on Serum Potassium · Phase 1 · terminated
- NCT03435276 — Multiple-ascending Dose Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD9977 in Healthy Male Subject · 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 NCT03843060 (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: 22 April 2019
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/NCT03843060.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing