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.
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Phase
Phase 1
Status
Completed
Study type
Interventional
Design
Randomized · None · Treatment
Enrollment
14actual
Sites
1
Country
United Kingdom
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2025-05-20 | actual | When the study began enrolling |
| Primary completion | 2025-07-12 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2025-07-12 | actual | The whole study's end, after follow-up |
| First posted | 2025-05-19 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2025-08-12 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Healthy Participants
Interventions
- Drug: balcinrenone/ dapagliflozin
- Drug: quinidine
Primary outcomes
what the primary-completion date above is the date OFArea under concentration-time curve from time zero to infinity (AUCinf)
measured From Day 1 to Day 10
Area under concentration-curve from time 0 to the last quantifiable concentration (AUClast)
measured From Day 1 to Day 10
Maximum observed drug concentration (Cmax)
measured From Day 1 to Day 10
Terminal elimination half-life (t1/2λz)
measured From Day 1 to Day 10
Time to reach maximum observed concentration (tmax)
measured From Day 1 to Day 10
Apparent volume of distribution based on the terminal phase (Vz/F)
measured From Day 1 to Day 10
Apparent total body clearance (CL/F)
measured From Day 1 to Day 10
Renal Clearance (CLR) (balcinrenone only)
measured From Day 1 to Day 10
Drug concentration in plasma at 24 hours post-dose (C24)
measured From Day 1 to Day 10
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