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.

NCT06979388 | Completed Phase 1

• 2 other identifiers: D6402C000091011789
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

The main purpose of this study is to assess 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.

Conditions

Healthy Participants

Keywords

Food effect; Mineralocorticoid receptor modulator; P-glycoprotein inhibitor; Fed and fasted state; Standardised high-fat and high-calorie meal

Outcome Measures

Primary Outcomes (9)

• Area under concentration-time curve from time zero to infinity (AUCinf)

  From Day 1 to Day 10

• Area under concentration-curve from time 0 to the last quantifiable concentration (AUClast)

  From Day 1 to Day 10

• Maximum observed drug concentration (Cmax)

  From Day 1 to Day 10

• Terminal elimination half-life (t1/2λz)

  From Day 1 to Day 10

• Time to reach maximum observed concentration (tmax)

  From Day 1 to Day 10

• Apparent volume of distribution based on the terminal phase (Vz/F)

  From Day 1 to Day 10

• Apparent total body clearance (CL/F)

  From Day 1 to Day 10

• Renal Clearance (CLR) (balcinrenone only)

  From Day 1 to Day 10

• Drug concentration in plasma at 24 hours post-dose (C24)

  From Day 1 to Day 10

Secondary Outcomes (1)

• Number of participants with adverse events (AEs) and serious adverse events (SAEs)

  From Screening (Day -28 to Day -2) until Follow-up (Day 12 to Day 14)

Study Arms (6)

Treatment ABC

EXPERIMENTAL

Participants will receive Treatment A (reference, fasted), balcinrenone/dapagliflozin capsule on Day 1 and then followed by a washout period of 72 hours. On Day 4, participants will receive Treatment B (fed), balcinrenone/dapagliflozin capsule dosed together with food, followed by a washout period of 72 hours. On Day 7, participants will receive Treatment C (quinidine, fasted), balcinrenone/dapagliflozin capsule dosed together with a P-gp inhibitor tablets (2 doses of quinidine separated by 4 hours, 1 hour prior and 3 hours post balcinrenone/dapagliflozin administration, respectively).

Drug: balcinrenone/ dapagliflozin; Drug: quinidine

Treatment ACB

EXPERIMENTAL

The participants will receive Treatment A (reference, fasted), balcinrenone/dapagliflozin capsule on Day 1 and then followed by washout period of 72 hours. On Day 4, participants will receive Treatment C (quinidine, fasted), balcinrenone/dapagliflozin capsule dosed together with a P-gp inhibitor tablets (2 doses of quinidine separated by 4 hours, 1 hour prior and 3 hours post balcinrenone/dapagliflozin administration, respectively), followed by a washout period of 72 hours. On Day 7, participants will receive Treatment B (fed), balcinrenone/dapagliflozin capsule dosed together with food.

Drug: balcinrenone/ dapagliflozin; Drug: quinidine

Treatment BCA

EXPERIMENTAL

The participants will receive Treatment B (fed), balcinrenone/dapagliflozin capsule dosed together with food on Day 1 and then followed by washout period of 72 hours. On Day 4, participants will receive Treatment C (quinidine, fasted), balcinrenone/dapagliflozin capsule dosed together with a P-gp inhibitor tablets (2 doses of quinidine separated by 4 hours, 1 hour prior and 3 hours post balcinrenone/dapagliflozin administration, respectively), followed by a washout period of 72 hours. On Day 7, participants will receive Treatment A (reference, fasted), balcinrenone/dapagliflozin capsule.

Drug: balcinrenone/ dapagliflozin; Drug: quinidine

Treatment BAC

EXPERIMENTAL

The participants will receive Treatment B (fed), balcinrenone/dapagliflozin capsule dosed together with food on Day 1 and then followed by washout period of 72 hours. On Day 4, participants will receive Treatment A (reference, fasted), balcinrenone/dapagliflozin capsule and then followed by washout period of 72 hours. On Day 7 participants will receive Treatment C (quinidine, fasted), balcinrenone/dapagliflozin capsule dosed together with a P-gp inhibitor tablets (2 doses of quinidine separated by 4 hours, 1 hour prior and 3 hours post balcinrenone/dapagliflozin administration, respectively).

Drug: balcinrenone/ dapagliflozin; Drug: quinidine

Treatment CAB

EXPERIMENTAL

The participants will receive Treatment C (quinidine, fasted), balcinrenone/dapagliflozin capsule dosed together with a P-gp inhibitor tablets (2 doses of quinidine separated by 4 hours, 1 hour prior and 3 hours post balcinrenone/dapagliflozin administration, respectively), followed by a washout period of 72 hours. On Day 4, participants will receive Treatment A (reference, fasted), balcinrenone/dapagliflozin capsule and then followed by washout period of 72 hours. On Day 7, participants will receive Treatment B (fed), balcinrenone/dapagliflozin capsule dosed together with food.

Drug: balcinrenone/ dapagliflozin; Drug: quinidine

Treatment CBA

EXPERIMENTAL

The participants will receive Treatment C (quinidine, fasted), balcinrenone/dapagliflozin capsule dosed together with a P-gp inhibitor tablets (2 doses of quinidine separated by 4 hours, 1 hour prior and 3 hours post balcinrenone/dapagliflozin administration, respectively), followed by a washout period of 72 hours. On Day 4, participants will receive Treatment B (fed), balcinrenone/dapagliflozin capsule dosed together with food, followed by a washout period of 72 hours. On Day 7, participants will receive Treatment A (reference, fasted), balcinrenone/dapagliflozin capsule.

Drug: balcinrenone/ dapagliflozin; Drug: quinidine

Interventions

balcinrenone/ dapagliflozin DRUG

Participants will be receiving balcinrenone/ dapagliflozine in fasted or fed condition.

Treatment ABC; Treatment ACB; Treatment BAC; Treatment BCA; Treatment CAB; Treatment CBA

quinidine DRUG

Participants will be receiving quinidine orally in fasted condition.

Treatment ABC; Treatment ACB; Treatment BAC; Treatment BCA; Treatment CAB; Treatment CBA

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AstraZeneca: lead
• Parexel: collaborator

Study Sites (1)

Research Site

Harrow, HA1 3UJ, United Kingdom

Location

MeSH Terms

Conditions

Lecithin Cholesterol Acyltransferase Deficiency; Fasting

Interventions

dapagliflozin; Quinidine

Condition Hierarchy (Ancestors)

Hypoalphalipoproteinemias; Hypolipoproteinemias; Lipid Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Feeding Behavior; Behavior

Intervention Hierarchy (Ancestors)

Cinchona Alkaloids; Alkaloids; Heterocyclic Compounds; Quinuclidines; Heterocyclic Compounds, Bridged-Ring; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2025
• First Posted: May 19, 2025
• Study Start: May 20, 2025
• Primary Completion: July 12, 2025
• Study Completion: July 12, 2025
• Last Updated: August 12, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• Access Criteria: When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.

Locations

GB (1)