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NCT03843060

A Phase 1 Study to Assess the Pharmacokinetics of AZD9977 Administered Alone and in Combination With Itraconazole in Healthy Volunteers

Completed Phase 1 Last updated 22 April 2019
What this trial tests

Phase 1 trial testing AZD9977 in Heart Failure With Preserved Ejection Fraction (HFpEF) in 14 participants. Completed in 1 April 2019.

Timeline
22 February 2019
Primary endpoint
1 April 2019
1 April 2019

Quick facts

Lead sponsorAstraZeneca
PhasePhase 1
StatusCompleted
Study typeINTERVENTIONAL
Allocationnon randomized
Designsequential
Maskingnone
Primary purposetreatment
Enrollment14
Start date22 February 2019
Primary completion1 April 2019
Estimated completion1 April 2019
Sites1 location across United States

Drugs / interventions tested

Conditions studied

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):

  1. 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
  2. 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
  3. 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:

Other trials of AZD9977

Trials testing the same drug.

Other recruiting trials for Heart Failure With Preserved Ejection Fraction (HFpEF)

Currently open trials in the same condition.

Other AstraZeneca 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/NCT03843060.

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