check_circleStudy Completed

Clinical Pharmacology

Bayer Identifier:

14502

ClinicalTrials.gov Identifier:

Not Available

EudraCT Number:

Not Available

EU CT Number:

Not Available
Finerenone mass balance study

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.

Key Participants Requirements

Sex

Male

Age

45 - 65 Years
  • - Healthy male subjects, 45 to 65 years (inclusive) of age, body mass index: 18 30 kg/m2

  • -

Trial summary

Enrollment Goal
12
Trial Dates
August 2012 - January 2013
Phase
Phase 1
Could I Receive a placebo
No
Products
Finerenone (BAY94-8862)
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Completed
Allschwil, 4123, Switzerland

Primary Outcome

  • AUC: area under the concentration vs. time curve from zero to infinity after single (first) dose
    date_rangeTime Frame:
    Part A
  • Cmax: maximum observed drug concentration in the measured matrix after single dose administration
    date_rangeTime Frame:
    Part A
  • AUC(0-tlast): AUC from time 0 to the last data point > LLOQ
    date_rangeTime Frame:
    Part B
  • AUC
    date_rangeTime Frame:
    Part B
  • Cmax
    date_rangeTime Frame:
    Part B
  • t1/2 (half-life associated with the terminal slope) for total [14C] radioactivity in blood and plasma
    date_rangeTime Frame:
    Part B
  • Metabolic profiling using radiochromatography: AUC
    date_rangeTime Frame:
    Part B
  • Metabolic profiling using radiochromatography: Cmax
    date_rangeTime Frame:
    Part B
  • Metabolic profiling using radiochromatography: tmax (time to reach Cmax (in case of two identical Cmax values, the first tmax will be used))
    date_rangeTime Frame:
    Part B
  • Metabolic profiling using radiochromatography: t1/2
    date_rangeTime Frame:
    Part B
  • Metabolic profiling using radiochromatography: AUC(0-tlast)
    date_rangeTime Frame:
    Part B
  • Metabolic profiling using radiochromatography: AE,ur (amount excreted into urine)
    date_rangeTime Frame:
    Part B
  • Metabolic profiling using radiochromatography: AE,fec (amount excreted into feces)
    date_rangeTime Frame:
    Part B

Secondary Outcome

  • AUC(0-tlast)
    date_rangeTime Frame:
    Part A
  • tmax
    date_rangeTime Frame:
    Part A
  • t1/2
    date_rangeTime Frame:
    Part A
  • CL/F: total body clearance of drug calculated after extravascular administration (apparent oral clearance)
    date_rangeTime Frame:
    Part A
  • Vz/F: apparent volume of distribution during terminal phase after extravascular administration
    date_rangeTime Frame:
    Part A
  • MRT: mean residence time
    date_rangeTime Frame:
    Part A
  • Number of participants with treatment emergent adverse events (TEAEs)
    date_rangeTime Frame:
    Part B

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