check_circleStudy Completed

Clinical Pharmacology

Bayer Identifier:

15111

ClinicalTrials.gov Identifier:

Not Available

EudraCT Number:

2016-001844-21

EU CT Number:

Not Available
Drug-drug interaction study with midazolam

Trial purpose

The primary objective of the study was to assess the influence of multiple doses of 20 mg finerenone administered once daily for 10 days on the pharmacokinetics of a single oral dose of 7.5 mg midazolam.
The secondary objective of the study was to assess the influence of multiple doses of 20 mg finerenone administered once daily for 10 days on the safety and tolerability of a single oral dose of midazolam.

Key Participants Requirements

Sex

Male

Age

18 - 45 Years
  • - Healthy male subjects between 18 and 45 years of age (inclusive)
    and with a body mass index ≥18 and ≤29.9 kg/m^2

  • -

Trial summary

Enrollment Goal
31
Trial Dates
September 2016 - February 2017
Phase
Phase 1
Could I Receive a placebo
No
Products
Kerendia (Finerenone, BAY94-8862)
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Completed
Berlin, 13353, Germany

Primary Outcome

  • Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC) of Midazolam in Plasma
    date_rangeTime Frame:
    Pre-dose to 24 hours post-dose
  • Maximum Observed Concentration (Cmax) of Midazolam in Plasma
    date_rangeTime Frame:
    Pre-dose to 24 hours post-dose

Secondary Outcome

  • Number of Subjects With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
    date_rangeTime Frame:
    From start of study drug administration until 3 days after the last dose of study treatment

Trial design

Single-center, randomized, non-blinded, non-placebo-controlled, two-fold cross-over study to investigate the influence of multiple doses of 20 mg OD finerenone on pharmacokinetics, safety and tolerability of a single oral dose of 7.5 mg midazolam in comparison to a single dose of 7.5 mg midazolam alone in healthy male subjects
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Other
Allocation
Randomized
Blinding
N/A
Assignment
Crossover Assignment
Trial Arms
2