check_circleStudy Completed
Clinical Pharmacology
Bayer Identifier:
16910
ClinicalTrials.gov Identifier:
Not Available
EudraCT Number:
EU CT Number:
Not Available
Finerenone / verapamil drug-drug interaction study
Trial purpose
The primary objective of this study was
• to investigate the influence of multiple oral doses of verapamil 240 mg once-daily on the pharmacokinetics of 5 mg finerenone given as a single oral dose in comparison to 5 mg finerenone given alone
The secondary objectives were
• to assess the safety and tolerability of the combined administration of both drugs
• to investigate the influence of multiple oral doses of verapamil 240 mg once-daily on the pharmacokinetics of 5 mg finerenone given as a single oral dose in comparison to 5 mg finerenone given alone
The secondary objectives were
• to assess the safety and tolerability of the combined administration of both drugs
Key Participants Requirements
Sex
MaleAge
18 - 45 YearsTrial summary
Enrollment Goal
13Trial Dates
July 2015 - December 2015Phase
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 Finerenone In Plasmadate_rangeTime Frame:0 h (pre-dose) to 23 h post-dose
- Maximum Observed Concentration (Cmax) of Finerenone In Plasmadate_rangeTime Frame:0 h (pre-dose) to 23 h post-dose
Secondary Outcome
- Number of Subjects with Treatment-emergent Adverse Events (TEAE) and Treatment-emergent serious adverse events (TESAE)date_rangeTime Frame:From start of study treatment up to 3 days after the last drug administration in Period 2
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
OtherAllocation
Non-randomizedBlinding
N/AAssignment
Single Group AssignmentTrial Arms
2