check_circleStudy Completed

Diabetic kidney disease

Bayer Identifier:

16536

ClinicalTrials.gov Identifier:

Not Available

EudraCT Number:

2016-000057-12

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.

Key Participants Requirements

Sex

Male

Age

18 - 45 Years
  • - Healthy male white subjects, 18 to 45 years of age, BMI: ≥ 18.0 and ≤ 29.9 kg/m^2

  • -

Trial summary

Enrollment Goal
18
Trial Dates
May 2016 - December 2016
Phase
Phase 1
Could I Receive a placebo
No
Products
Kerendia (Finerenone, BAY94-8862)
Accepts Healthy Volunteer
Yes

Primary Outcome

  • Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC) of Finerenone After Single Dose
    date_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 Dose
    date_rangeTime Frame:
    Pre-dose (0 hour) to 24 hours post-dose
  • Maximum Observed Finerenone Concentration in Measured Matrix (Cmax) After Single Dose
    date_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 Dose
    date_rangeTime Frame:
    Pre-dose (0 hour) to 24 hours post-dose

Secondary Outcome

  • Number of participants with treatment emergent adverse events
    date_rangeTime Frame:
    From the start of study treatment up to 3 days after the last dose of study drug

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