ArticleClinical pharmacokinetics2025
Population Pharmacokinetic Analysis of Balcinrenone in Healthy Participants and Participants with Heart Failure and Chronic Kidney Disease.
Article in Clinical pharmacokinetics, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It reports registered trial NCT04595370. Cited by 2 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Phase 2b, Randomised, Double-Blind, Active Controlled, Multi Centre Study to Evaluate the Efficacy, Safety and Tolerability of Oral AZD9977 and Dapagliflozin Treatment in Patients With Heart Failure and Chronic Kidney Disease
Open the trial in the graphA Phase I, Open Label, Randomized, Parallel Group, Multicentre Study to Compare the Effect of AZD9977 and Spironolactone on Serum Potassium [sK+] During 28 Days in Patients With HFmrEF or HFpEF and eGFR in the Range of ≥40 and ≤70 mL/Min/1.73m2.
An Open-label, Randomized, Four-way Crossover Single Oral Dose Study Comparing the Pharmacokinetics of Four Different Formulations of AZD9977 (Part A) and Influence of Food and Lower Dose of a Selected Formulation (Part B) in Healthy Male Subjects
A Phase 1 Single Center Open-label, Non-randomized, Fixed Sequence Study in Healthy Volunteers to Assess the Pharmacokinetics (PK) of AZD9977 When Administered Alone and With Itraconazole
A Single Dose, Non-Randomized, Open-Label, Parallel Group Study to Assess the Pharmacokinetics, Safety and Tolerability of AZD9977 in Participants With Renal Impairment
An Open-label, Randomized, Parallel Group, Four/Five Period, Eight Treatment Cross-over, Single Oral Dose Study to Assess the Relative Bioavailability of Different Formulations of AZD9977 and Dapagliflozin and Influence of Food in Selected Formulations in Healthy Volunteers
Who cites it
2 citing papers in PubMed.
- Effect of Food on Balcinrenone/Dapagliflozin Pharmacokinetics and the Pharmacokinetics of Balcinrenone When Dosed with a P-gp Inhibitor.Journal of clinical pharmacology · 2026Trial
- The effect of mild and moderate hepatic impairment on the pharmacokinetics, safety and tolerability of balcinrenone.British journal of clinical pharmacology · 2026Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
BACKGROUND AND
objectiveBalcinrenone is a novel mineralocorticoid receptor modulator which, based on preclinical data, maintains cardio-renal benefits without increasing hyperkalemia risk. Balcinrenone is developed in combination with dapagliflozin for the treatment of heart failure (HF) with impaired kidney function and chronic kidney disease (CKD). The aim of this work was to apply a population pharmacokinetic (popPK) approach to describe the pharmacokinetics (PK) of balcinrenone, and to quantify the effects of intrinsic and extrinsic factors on balcinrenone PK.
methodsThe assessment was based on data from six clinical studies in healthy participants (NCT03843060, NCT03804645, and NCT04798222), participants with renal impairment (NCT04469907), and participants with HF and CKD (NCT03682497 and NCT04595370) using the immediate-release capsule formulation (chosen for phase 3 studies).
resultsFood state (i.e., taking balcinrenone with or without food), renal function (estimated glomerular filtration rate [eGFR], incorporated using power function of eGFR on apparent clearance), and study type (phase 1 studies with mainly healthy participants or phase 1b/2b studies in patients with HF and CKD) were identified as covariates on balcinrenone exposure (area under the curve at steady-state [AUC
conclusionsParticipants with HF and CKD were observed to have approximately 50% lower apparent clearance compared with healthy participants and those with renal impairment, after adjusting for differences in eGFR. This may indicate that factors other than renal function may impact the apparent clearance of balcinrenone. The impact of the covariates on balcinrenone exposure (AUC
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Registered trials
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