check_circleStudy Completed

Clinical Pharmacology

Bayer Identifier:

16910

ClinicalTrials.gov Identifier:

Not Available

EudraCT Number:

2015-001465-58

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

Key Participants Requirements

Sex

Male

Age

18 - 45 Years
  • - Healthy male white subjects between 18 and 45 years of age (inclusive) and a body mass index ≥18 and ≤29.9 kg/ m²

  • -

Trial summary

Enrollment Goal
13
Trial Dates
July 2015 - December 2015
Phase
Phase 1
Could I Receive a placebo
No
Products
Kerendia (Finerenone, BAY94-8862)
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Completed
Berlin, 13353, Germany

Primary Outcome

  • Area Under The Concentration Versus Time Curve From Zero To Infinity (AUC) of Finerenone In Plasma
    date_rangeTime Frame:
    0 h (pre-dose) to 23 h post-dose
  • Maximum Observed Concentration (Cmax) of Finerenone In Plasma
    date_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

Non-blind, non-placebo-controlled study with 2 treatments in fixed sequence to investigate the effect of verapamil (240 mg controlled-release tablet) on the pharmacokinetics of a single dose of finerenone (5 mg) 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
Non-randomized
Blinding
N/A
Assignment
Single Group Assignment
Trial Arms
2