A Study to Investigate the Effect of Food on Balcinrenone/Dapagliflozin Pharmacokinetics in Fed and Fasted State and Pharmacokinetics of Balcinrenone When Dosed With a P-gp Inhibitor in Healthy Participants.

Launched by ASTRAZENECA · May 16, 2025

Keywords

ClinConnect Summary

This clinical trial is designed to study how food affects the way two medications, balcinrenone and dapagliflozin, are processed in the body. The researchers want to understand how these medications behave when taken with food compared to when they are taken on an empty stomach. They will also look at how balcinrenone works when combined with another type of medication that can affect its absorption. This study will involve healthy participants, and it is currently not recruiting volunteers.

To be eligible for this study, participants must be between 18 and 65 years old, have a body weight between 50 and 100 kg, and a Body Mass Index (BMI) between 18 and 30. Women who could become pregnant must have a negative pregnancy test and agree to use effective birth control. Participants should not have any significant health issues or take medications that could interfere with the study. Those who join can expect to undergo tests and assessments related to their health and how their bodies react to the medications being studied. It’s important to note that individuals with certain medical histories or conditions may not qualify for participation.

Gender

ALL

Eligibility criteria

• Main Inclusion Criteria:
• • Have a Body Mass Index (BMI) between 18 and 30 kg/m2 inclusive and weigh at least 50 kg and no more than 100 kg inclusive.
• • All females of childbearing potential must have a negative pregnancy test.
• • Females of childbearing potential must not be lactating and if heterosexually active must agree to use an approved method of highly effective contraception.
• Main Exclusion Criteria:
• • History of any clinically important disease or disorder which may either put the participant at risk because of participation in the study, or influence the results or the participant's ability to participate in the study
• • History or presence of gastrointestinal, hepatic, or renal disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.
• • Any clinically important illness, medical/major surgical procedure, or trauma within 4 weeks of the first administration of study intervention.
• • Any clinically important abnormalities in clinical chemistry, haematology, urinalysis or vital signs.
• • Positive result for serum hepatitis B surface antigen, hepatitis C antibody, and HIV antibody
• • History of long QT syndrome or history of additional risk factors for QT prolongation - for example a family history of long QT syndrome or the use of concomitant medications known to prolong the QT/QTc interval. Any clinically significant abnormalities on 12-lead ECG at the Screening Visit, as judged by the investigator, including but not limited to any significant arrythmia, conduction abnormalities, and/or prolonged QTcF \> 450 ms.
• • Current smokers or those who have smoked or used nicotine products within the previous 3 months prior to Screening Visit.
• • History of alcohol or drug abuse. Positive screen for drugs of abuse, alcohol or cotinine.
• • History of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity.
• • History of hypersensitivity to drugs with a similar chemical structure or class to balcinrenone, dapagliflozin and quinidine. Any contraindications listed for dapagliflozin and quinidine.
• • Use of drugs with enzyme inducing properties within 3 weeks prior to the first administration of study intervention.
• • Use of any prescribed or nonprescribed medication, herbal remedies or intake of \> 3 × daily recommended levels of vitamins and minerals during the 2 weeks prior to the first administration of study intervention
• • Plasma donation within one month of screening or any blood donation/blood loss \> 500 mL during the 3 months prior to screening.