check_circleStudy Completed

Clinical Pharmacology

Bayer Identifier:

14505

ClinicalTrials.gov Identifier:

Not Available

EudraCT Number:

2014-004083-38

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.

Key Participants Requirements

Sex

Male

Age

18 - 45 Years
  • - Healthy male subjects, white, age: 18 to 45 years, body mass index: ≥ 18.0 and ≤ 29.9 kg/m².

  • -

Trial summary

Enrollment Goal
24
Trial Dates
June 2015 - April 2016
Phase
Phase 1
Could I Receive a placebo
No
Products
Kerendia (Finerenone, BAY94-8862)
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
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 10
    date_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 10
    date_rangeTime Frame:
    Pre-dose on treatment Day 8, 9, and 10

Secondary Outcome

  • Number of Subjects With Treatment Emergent Adverse Events (TEAEs)-Overall
    date_rangeTime Frame:
    From start of study treatment until 7 days after last administration of the study medication

Trial design

Randomized, non-blind, non-placebo-controlled, 2-fold cross-over study with additional 1st period with fixed treatment to investigate the pharmacokinetic interaction between finerenone (20 mg once-daily) and digoxin (0.375 mg once-daily) and to investigate the safety and tolerability of the combined administration in healthy male subjects
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Other
Allocation
Randomized
Blinding
N/A
Assignment
Crossover Assignment
Trial Arms
2