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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Participants will be receiving balcinrenone/ dapagliflozin before or after hemodialysis
Research Site
Orlando, Florida, United States
RECRUITINGPK parameters AUCinf
To evaluate the effect of HD on the PK of balcinrenone/dapagliflozin
Time frame: Day 1 to 3 for each treatment period (each treatment period is 4 days)
PK Parameters AUClast
To evaluate the effect of HD on the PK of balcinrenone/dapagliflozin
Time frame: Day 1 to 3 for each treatment period (each treatment period is 4 days)
PK Parameters Cmax
To evaluate the effect of HD on the PK of balcinrenone/dapagliflozin
Time frame: Day 1 to 3 for each treatment period (each treatment period is 4 days)
PK parameters C24 from plasma
To evaluate the PK of balcinrenone/dapagliflozin in plasma in participants with kidney failure on HD
Time frame: Day 1 to 3 for each treatment period (each treatment period is 4 days)
PK parameters tmax from plasma
To evaluate the PK of balcinrenone/dapagliflozin in plasma in participants with kidney failure on HD
Time frame: Day 1 to 3 for each treatment period (each treatment period is 4 days)
PK parameters t1/2λz from plasma
To evaluate the PK of balcinrenone/dapagliflozin in plasma in participants with kidney failure on HD
Time frame: Day 1 to 3 for each treatment period (each treatment period is 4 days)
PK parameters CLNR (balcinrenone only) from plasma
To evaluate the PK of balcinrenone/dapagliflozin in plasma in participants with kidney failure on HD
Time frame: Day 1 to 3 for each treatment period (each treatment period is 4 days)
AstraZeneca Clinical Study Information Center
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PK parameters CL/F from plasma
To evaluate the PK of balcinrenone/dapagliflozin in plasma in participants with kidney failure on HD
Time frame: Day 1 to 3 for each treatment period (each treatment period is 4 days)
PK parameters AUC(t1-t2)_out from plasma
To evaluate the PK of balcinrenone/dapagliflozin in plasma in participants with kidney failure on HD
Time frame: Day 1 to 3 for each treatment period (each treatment period is 4 days)
PK parameters CLD from dialysate
To evaluate the PK of balcinrenone/dapagliflozin in dialysate in participants with kidney failure on HD
Time frame: Day 1 to 3 for each treatment period (each treatment period is 4 days)
PK parameters AeD from dialysate
To evaluate the PK of balcinrenone/dapagliflozin in dialysate in participants with kidney failure on HD
Time frame: Day 1 to 3 for each treatment period (each treatment period is 4 days)
PK parameters feD from dialysate
To evaluate the PK of balcinrenone/dapagliflozin in dialysate in participants with kidney failure on HD
Time frame: Day 1 to 3 for each treatment period (each treatment period is 4 days)
PK parameters Vz/F from plasma
To evaluate the PK of balcinrenone/dapagliflozin in plasma in participants with kidney failure on HD
Time frame: Day 1 to 3 for each treatment period (each treatment period is 4 days)
PK parameters AUC(t1-t2) from plasma
To evaluate the PK of balcinrenone/dapagliflozin in plasma in participants with kidney failure on HD
Time frame: Day 1 to 3 for each treatment period (each treatment period is 4 days)
AEs
To assess the safety and tolerability of single doses of balcinrenone/dapagliflozin in participants with kidney failure on HD
Time frame: from Period 1, Day 1 until follow-up on Day 9-11 post-dose Period 2.
SAEs
To assess the safety and tolerability of single doses of balcinrenone/dapagliflozin in participants with kidney failure on HD
Time frame: from screening until follow-up on Day 9-11 post-dose Period 2