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
AstraZeneca
Summary
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.
Eligibility
- Age range
- 18–80 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Participant must have kidney failure and must have been on stable intermittent HD for at least 3 months prior to screening. * Participant must be stable on a concomitant medication and/or treatment regimen (defined as not starting a new treatment/medication\[s\] or a change in the dosage or frequency of the concomitant medication\[s\] within at least 4 weeks prior to screening). * Participants with controlled T2DM may be included, if they have: (a) HbA1c ≤ 10% at screening. * Body weight ≥ 50 kg and BMI within the range 18 to 40 kg/m2, inclusive, as measured at screening…
Interventions
- DrugBalcinrenone/dapagliflozin
40 mg/10 mg balcinrenone/dapagliflozin (capsule)
Location
- Research SiteOrlando, Florida