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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
14
Participants will be receiving balcinrenone/ dapagliflozine in fasted or fed condition.
Participants will be receiving quinidine orally in fasted condition.
Research Site
Harrow, United Kingdom
Area under concentration-time curve from time zero to infinity (AUCinf)
Time frame: From Day 1 to Day 10
Area under concentration-curve from time 0 to the last quantifiable concentration (AUClast)
Time frame: From Day 1 to Day 10
Maximum observed drug concentration (Cmax)
Time frame: From Day 1 to Day 10
Terminal elimination half-life (t1/2λz)
Time frame: From Day 1 to Day 10
Time to reach maximum observed concentration (tmax)
Time frame: From Day 1 to Day 10
Apparent volume of distribution based on the terminal phase (Vz/F)
Time frame: From Day 1 to Day 10
Apparent total body clearance (CL/F)
Time frame: From Day 1 to Day 10
Renal Clearance (CLR) (balcinrenone only)
Time frame: From Day 1 to Day 10
Drug concentration in plasma at 24 hours post-dose (C24)
Time frame: From Day 1 to Day 10
Number of participants with adverse events (AEs) and serious adverse events (SAEs)
Time frame: From Screening (Day -28 to Day -2) until Follow-up (Day 12 to Day 14)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.