Phase 1Completed
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.
- Sponsor
- AstraZeneca (Industry)
- Enrolment
- 14 enrolled
- Conditions
- Healthy Participants
- Interventions
- balcinrenone/ dapagliflozin; quinidine
- Ages
- adults
- Registry
- NCT06979388
Full record on ClinicalTrials.gov
From the registry
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.
Primary outcomes
- Area under concentration-time curve from time zero to infinity (AUCinf)
- Area under concentration-curve from time 0 to the last quantifiable concentration (AUClast)
- Maximum observed drug concentration (Cmax)
- Terminal elimination half-life (t1/2λz)
History
Last registry update
Primary completion
Started
Registered