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.
-
- STATUS
- Not Recruiting
-
- participants needed
- 14
-
- sponsor
- AstraZeneca
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.
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.
Details
| Condition | Healthy Participants |
|---|---|
| Age | 18years - 55years |
| Clinical Study Identifier | NCT06979388 |
| Sponsor | AstraZeneca |
| Last Modified on | 19 May 2025 |
Similar trials to consider
Browse trials for
Not finding what you're looking for?
Sign up as a volunteer to stay informed
Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.
Sign up as volunteerStudy Definition
WikipediaAdd a private note
- Select a piece of text.
- Add notes visible only to you.
- Send it to people through a passcode protected link.