check_circleStudy Completed

Clinical Pharmacology

Bayer Identifier:

15112

ClinicalTrials.gov Identifier:

Not Available

EudraCT Number:

2014-001260-35

EU CT Number:

Not Available
Drug-drug interaction study to investigate the effect of gemfibrozil on finerenone

Trial purpose

The primary objective of the study was to investigate the influence of multiple oral doses of gemfibrozil 600 mg bid on the pharmacokinetics of 10 mg finerenone.
The secondary objective of the study was to assess the safety and tolerability of 10 mg finerenone given as a single oral dose on the background of gemfibrozil in comparison to 10 mg finerenone given alone.

Key Participants Requirements

Sex

Male

Age

18 - 45 Years
  • - Healthy white male subjects between 18 and 45 years (inclusive) of age and a body mass index between 18 and 29.9 kg/m2 (both inclusive)

  • -

Trial summary

Enrollment Goal
16
Trial Dates
March 2015 - June 2015
Phase
Phase 1
Could I Receive a placebo
No
Products
Kerendia (Finerenone, BAY94-8862)
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Completed
Mannheim, 68167, Germany

Primary Outcome

  • Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC) of Finerenone in Plasma
    date_rangeTime Frame:
    Treatment A and B: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 15, 24, 36, 48 hours postdose
  • Maximum Observed Drug Concentration (Cmax) of Finerenone in Plasma
    date_rangeTime Frame:
    Treatment A and B: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 15, 24, 36, 48 hours post dose

Secondary Outcome

  • Number of subjects with treatment emergent adverse events (TEAEs)
    date_rangeTime Frame:
    From the start of study treatment up to 14 days after the last study drug administration

Trial design

Randomized, non-blinded, non-placebo-controlled, two-fold cross-over study to investigate the influence of multiple doses of 600 mg gemfibrozil twice-daily on the pharmacokinetics, safety and tolerability of a single oral dose of 10 mg finerenone in comparison to a single dose of 10 mg of finerenone 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