Finerenone mass balance study
Primary objectives of the study were:
• to investigate the bioavailability of a novel formulation, the aqueous solution of finerenone compared to a 10 mg IR tablet in healthy male subjects in order to decide on the use of this formulation versus the alternative option (PEG solution) in Part B of the study.
• to measure the cumulative amount as well as the time course of drug-related, radiolabeled material excreted in the urine and feces following a single dose of 10 mg [14C]finerenone (oral solution).
• to characterize the metabolite pattern in plasma, urine, and feces and to identify metabolites where possible (the results will be reported under separate cover).
• to quantify total radioactivity in blood and plasma.
• to quantify finerenone and metabolites circulating in plasma, if possible (the results will be reported under separate cover).
Secondary objective of the study was to assess the safety and tolerability of an oral single dose of 10 mg finerenone in healthy subjects.
- Healthy male subjects, 45 to 65 years (inclusive) of age, body mass index: 18 30 kg/m2
No Exclusion Criteria Available
Allschwil, Switzerland, 4123
E-mail: [email protected]
Phone: (+)1-888-84 22937
Single center, open-label, non-placebo-controlled, single-dose study in healthy male subjects to compare the bioavailability of 10 mg finerenone aqueous oral solution and tablet (Part A; randomized) and to investigate the metabolism, excretion pattern and mass balance of 10 mg [14C]finerenone oral solution (Part B; non-randomized).