check_circleStudy Completed
Clinical Pharmacology
Bayer Identifier:
15112
ClinicalTrials.gov Identifier:
Not Available
EudraCT Number:
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.
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
MaleAge
18 - 45 YearsTrial summary
Enrollment Goal
16Trial Dates
March 2015 - June 2015Phase
Phase 1Could I Receive a placebo
NoProducts
Kerendia (Finerenone, BAY94-8862)Accepts Healthy Volunteer
YesWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Mannheim, 68167, Germany |
Primary Outcome
- Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC) of Finerenone in Plasmadate_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 Plasmadate_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
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
OtherAllocation
RandomizedBlinding
N/AAssignment
Crossover AssignmentTrial Arms
2