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.
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.
Presence of any uncontrolled or clinically significant disease or disorder (other than renal disease and conditions related to the renal disease, such as stable T2DM and stable hypertension), or any medical or surgical condition that, in the opinion of the investigator, may either interfere with participation in the clinical study and/or put the participant at significant risk (according to the investigator's judgement) if he/she participates in the clinical study.
Any clinically significant illness, medical/major surgical procedure, or trauma within 4 weeks prior to the first study intervention
Severe hepatic impairment (CP Class C).
History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, as judged by the investigator, or history of hypersensitivity to drugs with a similar chemical structure or class to balcinrenone and dapagliflozin
Crossover
Balcinrenone/dapagliflozin
DrugParticipants will be receiving balcinrenone/ dapagliflozin before or after hemodialysis
PK parameters AUCinf
To evaluate the effect of HD on the PK of balcinrenone/dapagliflozin
PK Parameters AUClast
To evaluate the effect of HD on the PK of balcinrenone/dapagliflozin
PK Parameters Cmax
To evaluate the effect of HD on the PK of balcinrenone/dapagliflozin
PK parameters C24 from plasma
To evaluate the PK of balcinrenone/dapagliflozin in plasma in participants with kidney failure on HD
AEs
To assess the safety and tolerability of single doses of balcinrenone/dapagliflozin in participants with kidney failure on HD
SAEs
To assess the safety and tolerability of single doses of balcinrenone/dapagliflozin in participants with kidney failure on HD
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AstraZeneca
Lead sponsor
Fortrea
Collaborator
