check_circleStudy Completed
Clinical Pharmacology
Bayer Identifier:
14505
ClinicalTrials.gov Identifier:
Not Available
EudraCT Number:
EU CT Number:
Not Available
Finerenone/digoxin drug-drug interaction study
Trial purpose
The primary objective of the study was to investigate the influence of a concomitant intake of multiple doses of 20 mg finerenone administered once-daily (od) for 10 days on the steady-state pharmacokinetics of digoxin (0.375 mg od).
The secondary objective was to assess the safety and tolerability of the combined administration of both drugs and to determine the influence of multiple doses of digoxin (0.375 mg od) on the pharmacokinetics of a single dose of 20 mg finerenone.
The secondary objective was to assess the safety and tolerability of the combined administration of both drugs and to determine the influence of multiple doses of digoxin (0.375 mg od) on the pharmacokinetics of a single dose of 20 mg finerenone.
Key Participants Requirements
Sex
MaleAge
18 - 45 YearsTrial summary
Enrollment Goal
24Trial Dates
June 2015 - April 2016Phase
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 During Any Dose Interval at Steady State (AUCtau,ss) of Digoxin on Day 10date_rangeTime Frame:0 hour (h) (pre-dose) to 24 h post-dose following the dose on day 10 of treatment period 2 and 3
- Drug Concentration in Plasma at Steady State (Ctrough,ss) at Pre-dose of Digoxin on Day 8, 9, and 10date_rangeTime Frame:Pre-dose on treatment Day 8, 9, and 10
Secondary Outcome
- Number of Subjects With Treatment Emergent Adverse Events (TEAEs)-Overalldate_rangeTime Frame:From start of study treatment until 7 days after last administration of the study medication
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
OtherAllocation
RandomizedBlinding
N/AAssignment
Crossover AssignmentTrial Arms
2