Trial Condition(s):
Diabetic Kidney Disease
Relative Bioavailability and food effect study with finerenone
Bayer Identifier:
16536
ClinicalTrials.gov Identifier:
Not Available
EudraCT Number:
EU CT Number:
Not Available
Trial Purpose
The primary objectives of the study were to
• investigate the pharmacokinetic dose proportionality of a single oral dose of 10 mg tablet in comparison to 20 mg tablet in the fasting condition
• investigate the effect of a high fat, high calorie meal on the pharmacokinetics after a single oral dose of 20 mg tablet
The secondary objective of this study was to investigate the safety and tolerability of single oral doses of finerenone.
Inclusion Criteria
- Healthy male white subjects, 18 to 45 years of age, BMI: ≥ 18.0 and ≤ 29.9 kg/m^2
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 |
|---|
Trial Design
Relative bioavailability study to investigate the pharmacokinetic dose proportionality, safety and tolerability of single oral doses of finerenone 10 mg tablet in comparison to 20 mg tablet in the fasting condition and to investigate the effect of a high fat, high calorie meal on the 20 mg tablet in healthy male subjects in a randomized, open-label, three-fold crossover design
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Other
Allocation:
Randomized
Blinding:
Open Label
Assignment:
Crossover Assignment
Trial Arms:
3
Primary Outcome
- Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC) of Finerenone After Single DoseTimeframe: Pre-dose (0 hour) to 24 hours post-dose
- Area Under the Concentration Versus Time Curve From Zero to Infinity Divided by Dose (AUC/D) of Finerenone After Single DoseTimeframe: Pre-dose (0 hour) to 24 hours post-dose
- Maximum Observed Finerenone Concentration in Measured Matrix (Cmax) After Single DoseTimeframe: Pre-dose (0 hour) to 24 hours post-dose
- Maximum Observed Finerenone Concentration in Measured Matrix Divided by Dose (Cmax/D) After Single DoseTimeframe: Pre-dose (0 hour) to 24 hours post-dose
Secondary Outcome
- Number of participants with treatment emergent adverse eventsTimeframe: From the start of study treatment up to 3 days after the last dose of study drug
Additional Information
Not Available
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