Trial Condition(s):
Clinical Pharmacology
Finerenone mass balance study
Bayer Identifier:
14502
ClinicalTrials.gov Identifier:
Not Available
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
Primary objectives of the study were:
Part A
• 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.
Part B
• 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.
Inclusion Criteria
- Healthy male subjects, 45 to 65 years (inclusive) of age, body mass index: 18 30 kg/m2
Exclusion Criteria
No Exclusion Criteria Available
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Investigative Site Allschwil, Switzerland, 4123 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Trial Design
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).
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Other
Allocation:
Randomized
Blinding:
N/A
Assignment:
Crossover Assignment
Trial Arms:
3
Primary Outcome
- AUC: area under the concentration vs. time curve from zero to infinity after single (first) doseTimeframe: Part A
- Cmax: maximum observed drug concentration in the measured matrix after single dose administrationTimeframe: Part A
- AUC(0-tlast): AUC from time 0 to the last data point > LLOQTimeframe: Part B
- AUCTimeframe: Part B
- CmaxTimeframe: Part B
- t1/2 (half-life associated with the terminal slope) for total [14C] radioactivity in blood and plasmaTimeframe: Part B
- Metabolic profiling using radiochromatography: AUCTimeframe: Part B
- Metabolic profiling using radiochromatography: CmaxTimeframe: Part B
- Metabolic profiling using radiochromatography: tmax (time to reach Cmax (in case of two identical Cmax values, the first tmax will be used))Timeframe: Part B
- Metabolic profiling using radiochromatography: t1/2Timeframe: Part B
- Metabolic profiling using radiochromatography: AUC(0-tlast)Timeframe: Part B
- Metabolic profiling using radiochromatography: AE,ur (amount excreted into urine)Timeframe: Part B
- Metabolic profiling using radiochromatography: AE,fec (amount excreted into feces)Timeframe: Part B
Secondary Outcome
- AUC(0-tlast)Timeframe: Part A
- tmaxTimeframe: Part A
- t1/2Timeframe: Part A
- CL/F: total body clearance of drug calculated after extravascular administration (apparent oral clearance)Timeframe: Part A
- Vz/F: apparent volume of distribution during terminal phase after extravascular administrationTimeframe: Part A
- MRT: mean residence timeTimeframe: Part A
- Number of participants with treatment emergent adverse events (TEAEs)Timeframe: Part B
Additional Information
Not Available
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