Phase 1Recruiting
Study of the Effect of Haemodialysis on the Pharmacokinetics, Safety, and Tolerability of Balcinrenone/Dapagliflozin
A Phase I, Single-Centre, Randomised, Single-dose, Open-label, 2-period, 2-way Crossover Study to Assess the Effect of Haemodialysis on the Pharmacokinetics, Safety, and Tolerability of Balcinrenone/Dapagliflozin in Participants With Kidney Failure
- Sponsor
- AstraZeneca (Industry)
- Enrolment
- 10 planned
- Conditions
- Kidney Failure
- Interventions
- Balcinrenone/dapagliflozin
- Ages
- adults, older adults
- Registry
- NCT07754331
Full record on ClinicalTrials.gov
From the registry
The purpose of this study is to investigate the effect of HD on single oral dose PK, safety, and tolerability of balcinrenone/dapagliflozin to male and female participants with kidney failure on intermittent HD.
Primary outcomes
- PK parameters AUCinf
- PK Parameters AUClast
- PK Parameters Cmax
- PK parameters C24 from plasma
History
Primary completion expected
Last registry update
Registered
Started