NCT06979388

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.

A Phase I, Randomised, Single-dose, Open-label, 3-period, 3-treatment, 3-way Crossover Study 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.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Detailed description

This study will be an open-label, randomised, 3-period, 3-treatment, single-dose, 3-way crossover study in healthy participants (males and females), performed at a single study site. The study comprises of: * Screening period of 4 weeks within the interval of Day -28 and Day -2. * Three treatment periods during which participants will be residing at the Clinical Unit from the day before the first study intervention administration (Day -1). The participant will be discharged on Day 10. * Treatment A (reference, fasted), balcinrenone/dapagliflozin capsule dosed in the fasted state. * Treatment B (fed), balcinrenone/dapagliflozin capsule dosed together with food. * Treatment C (quinidine, fasted), balcinrenone/dapagliflozin capsule (dosed together with a P-gp inhibitor tablets (quinidine) in fasted state. Participants will be randomised on Day 1 to one of the following 6 treatment sequences: ABC, ACB, BCA, BAC, CAB, or CBA. Each participant will receive all 3 treatments (A, B, and C) in the sequence participant was randomised to. Each treatment will be separated by a washout period of 72 hours; thus, each participant will receive study intervention on Day 1, Day 4, and Day 7. • A final Follow-up Call within 5 - 7 days (Day 12-14) after the last study intervention administration.

Conditions

• Healthy Participants

Interventions

Type	Name	Description
DRUG	balcinrenone/ dapagliflozin	Participants will be receiving balcinrenone/ dapagliflozine in fasted or fed condition.
DRUG	quinidine	Participants will be receiving quinidine orally in fasted condition.

Timeline

• Start date: 2025-05-20
• Primary completion: 2025-07-12
• Completion: 2025-07-12
• First posted: 2025-05-19
• Last updated: 2025-08-12

Locations

1 site across 1 country: United Kingdom