check_circleStudy Completed

Diabetic kidney disease

Bayer Identifier:

19092

ClinicalTrials.gov Identifier:

Not Available

EudraCT Number:

2017-001776-37

EU CT Number:

Not Available
Pilot bioavailability study with finerenone

Trial purpose

The primary objective of the study was to
• investigate the relative bioavailability of 20 mg finerenone tablet manufactured in a continuous process (ConsiGma) in comparison to 20 mg finerenone tablet manufactured in a batch process (i.e. the current Phase 3 formulation) in the fasting condition
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 (inclusive), Body mass index (BMI): ≥ 18.0 and ≤ 29.9 kg/m²

  • -

Trial summary

Enrollment Goal
16
Trial Dates
September 2017 - February 2018
Phase
Phase 1
Could I Receive a placebo
No
Products
Kerendia (Finerenone, BAY94-8862)
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Completed
CRS Clinical-Research-Services Mönchengladbach GmbHMönchengladbach, 41061, Germany

Primary Outcome

  • Maximum observed concentration (Cmax) after single dose administration of finerenone
    date_rangeTime Frame:
    From pre-dose up to 24 hours after drug administration in each treatment period
  • Area under concentration versus time curve from zero to infinity (AUC) after single dose administration of finerenone
    date_rangeTime Frame:
    From pre-dose up to 24 hours after drug administration in each treatment period

Secondary Outcome

  • Number of participants with adverse events
    date_rangeTime Frame:
    From first application of study medication up to 3 days after last study drug

Trial design

Single dose, open-label, randomized, two-fold crossover study in healthy male subjects to investigate the bioavailability of 20 mg finerenone immediate-release tablets manufactured in a continuous process (ConsiGma) in comparison to tablets manufactured in a batch process (current Phase 3 formulation)
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Other
Allocation
Randomized
Blinding
N/A
Assignment
Crossover Assignment
Trial Arms
2