check_circleStudy Completed

Clinical Pharmacology

Bayer Identifier:

16541

ClinicalTrials.gov Identifier:

Not Available

EudraCT Number:

2014-002088-13

EU CT Number:

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

Trial purpose

The primary objective of this study is
- to investigate the influence of a single oral dose of finerenone 20 mg on the pharmacokinetics of 0.5 mg repaglinide, given as a single oral dose in combination with 20 mg finerenone or 3 h after administration of 20 mg finerenone, in comparison to 0.5 mg repaglinide given alone.
The secondary objective of this study is:
- to investigate the influence of a single oral dose of finerenone 20 mg on the pharmacodynamics (blood glucose concentration), safety and tolerability of 0.5 mg repaglinide, given as a single oral dose in combination with 20 mg finerenone or 3 h after administration of 20 mg finerenone, in comparison to 0.5 mg repaglinide given alone.

Key Participants Requirements

Sex

Male

Age

18 - 45 Years
  • - Healthy white male subjects aged between 18 and 45 years (inclusive) with a body mass index ≥18 and ≤29.9 kg/m².

  • -

Trial summary

Enrollment Goal
29
Trial Dates
September 2014 - May 2015
Phase
Phase 1
Could I Receive a placebo
No
Products
Finerenone (BAY94-8862)
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Completed
Wuppertal, 42113, Germany

Primary Outcome

  • Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC) of Repaglinide in Plasma After Single Dose
    date_rangeTime Frame:
    0 (pre-dose) to 24 h post-dose on Day 0
  • Maximum Observed Drug Concentration (Cmax) of Repaglinide in Plasma After a Single Dose
    date_rangeTime Frame:
    0 (pre-dose) to 24 h post-dose on Day 0

Secondary Outcome

  • Blood glucose concentration
  • Number of participants with adverse events
    date_rangeTime Frame:
    From start of study treatment up to follow-up visit at least 7 days after last study drug administered

Trial design

Randomized, open-label, non-placebo-controlled, threefold cross-over study to investigate the effect of a single dose of 20 mg finerenone given concomitantly or 3 hours before repaglinide on the pharmacokinetics, safety and tolerability of a single oral dose of 0.5 mg repaglinide in comparison to 0.5 mg repaglinide alone in healthy male subjects
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Other
Allocation
Randomized
Blinding
N/A
Assignment
Crossover Assignment
Trial Arms
6