This is a Phase I, Multicentre study to Compare the Effect of AZD9977 and Spironolactone on Serum Potassium \[sK+\] during 28 days in Patients with HFmrEF or HFpEF and eGFR in the range of ≥40 and ≤70 mL/min/1.73m2.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
68
AZD9977 capsules taken orally for 28 days.
Spironolactone tablets taken orally for 28 days.
Research Site
Plovdiv, Bulgaria
Research Site
Sofia, Bulgaria
Research Site
Sofia, Bulgaria
Relative change (%) from baseline in serum potassium
To compare the effect of AZD9977 with spironolactone on serum potassium (sK+)
Time frame: Measurements on day 1, 7, 14, 21 and 28 will be used. The primary comparison between Spironolactone and AZD9977 will be done at day 28.
Plasma trough concentrations (Ctrough) values of spironolactone and AZD9977
To evaluate the pharmacokinetics (PK) of AZD9977 and spironolactone
Time frame: PK samples will be taken (within 60 min prior to dose) at day 1, 7, 14, 21 and 28.
Relative change (%) from baseline in serum potassium
To compare the effects of AZD9977 with spironolactone on serum potassium at Day 14.
Time frame: Measurements on day 1, 7 and 14 will be used. The primary comparison between Spironolactone and AZD9977 will be done at day 14.
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Research Site
Brandýs nad Labem, Czechia
Research Site
Česká Lípa, Czechia
Research Site
Jaroměř, Czechia
Research Site
Louny, Czechia
Research Site
Pardubice, Czechia
Research Site
Prague, Czechia
Research Site
Prague, Czechia
...and 8 more locations