check_circleStudy Completed
Clinical Pharmacology
Bayer Identifier:
15111
ClinicalTrials.gov Identifier:
Not Available
EudraCT Number:
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.
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
MaleAge
18 - 45 YearsTrial summary
Enrollment Goal
31Trial Dates
September 2016 - February 2017Phase
Phase 1Could I Receive a placebo
NoProducts
Kerendia (Finerenone, BAY94-8862)Accepts Healthy Volunteer
YesWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Berlin, 13353, Germany |
Primary Outcome
- Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC) of Midazolam in Plasmadate_rangeTime Frame:Pre-dose to 24 hours post-dose
- Maximum Observed Concentration (Cmax) of Midazolam in Plasmadate_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
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
OtherAllocation
RandomizedBlinding
N/AAssignment
Crossover AssignmentTrial Arms
2