check_circleStudy Completed
Diabetic kidney disease
Bayer Identifier:
16536
ClinicalTrials.gov Identifier:
Not Available
EudraCT Number:
EU CT Number:
Not Available
Relative Bioavailability and food effect study with finerenone
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.
• 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.
Key Participants Requirements
Sex
MaleAge
18 - 45 YearsTrial summary
Enrollment Goal
18Trial Dates
May 2016 - December 2016Phase
Phase 1Could I Receive a placebo
NoProducts
Kerendia (Finerenone, BAY94-8862)Accepts Healthy Volunteer
YesPrimary Outcome
- Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC) of Finerenone After Single Dosedate_rangeTime Frame: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 Dosedate_rangeTime Frame:Pre-dose (0 hour) to 24 hours post-dose
- Maximum Observed Finerenone Concentration in Measured Matrix (Cmax) After Single Dosedate_rangeTime Frame:Pre-dose (0 hour) to 24 hours post-dose
- Maximum Observed Finerenone Concentration in Measured Matrix Divided by Dose (Cmax/D) After Single Dosedate_rangeTime Frame:Pre-dose (0 hour) to 24 hours post-dose
Secondary Outcome
- Number of participants with treatment emergent adverse eventsdate_rangeTime Frame:From the start of study treatment up to 3 days after the last dose of study drug
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
OtherAllocation
RandomizedBlinding
Open LabelAssignment
Crossover AssignmentTrial Arms
3