check_circleStudy Completed
Clinical Pharmacology
Bayer Identifier:
16541
ClinicalTrials.gov Identifier:
Not Available
EudraCT Number:
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.
- 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
MaleAge
18 - 45 YearsTrial summary
Enrollment Goal
29Trial Dates
September 2014 - May 2015Phase
Phase 1Could I Receive a placebo
NoProducts
Finerenone (BAY94-8862)Accepts Healthy Volunteer
YesWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Wuppertal, 42113, Germany |
Primary Outcome
- Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC) of Repaglinide in Plasma After Single Dosedate_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 Dosedate_rangeTime Frame:0 (pre-dose) to 24 h post-dose on Day 0
Secondary Outcome
- Blood glucose concentration
- Number of participants with adverse eventsdate_rangeTime Frame:From start of study treatment up to follow-up visit at least 7 days after last study drug administered
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
OtherAllocation
RandomizedBlinding
N/AAssignment
Crossover AssignmentTrial Arms
6