check_circleStudy Completed

Clinical Pharmacology

Bayer Identifier:

15113

ClinicalTrials.gov Identifier:

Not Available

EudraCT Number:

2014-000191-26

EU CT Number:

Not Available
Investigation of the effect of finerenone on the QTc interval

Trial purpose

Primary objective:
• To rule out an effect (i.e. to demonstrate a lack of effect) of a single 20 mg and 80 mg oral dose of finerenone on manually read QT interval corrected for heart rate (QTc) as compared to placebo
Secondary objectives:
• To assess / validate the sensitivity of the assessment of the QT interval corrected for heart rate (QTc), to characterize the effect of a single oral dose of 400 mg of moxifloxacin on QTc value relative to placebo
• To characterize the effect on HR relative to placebo of single oral doses of 400 mg of moxifloxacin, 20 mg and 80 mg of finerenone
• To characterize the plasma exposure of finerenone and moxifloxacin
• To explore the relationship between moxifloxacin exposure and ECG parameters (QTc and HR)

Key Participants Requirements

Sex

All

Age

18 - 55 Years
  • - Healthy male or female white subjects between 18 and 55 years of
    age

  • -

Trial summary

Enrollment Goal
60
Trial Dates
June 2014 - January 2015
Phase
Phase 1
Could I Receive a placebo
Yes
Products
Finerenone (BAY94-8862)
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Completed
Mannheim, 68167, Germany

Primary Outcome

  • Time-matched Placebo-corrected Change From Baseline of the QT Interval Corrected According to Fridericia (QTcF) at Specified Time Points Post-treatment With Finerenone
    date_rangeTime Frame:
    0 hours (h) (pre-dose) to 48 h post-dose

Secondary Outcome

  • Area Under the Concentration Versus Time Curve From Zero to Infinity Divided by Dose (AUC/D) of Finerenone and its Metabolites in Plasma
    date_rangeTime Frame:
    0 h (pre-dose) to 48 h post-dose
  • Maximum Observed Drug Concentration Divided by Dose (Cmax/D) of Finerenone and its Metabolites in Plasma
    date_rangeTime Frame:
    0 h (pre-dose) to 48 h post-dose
  • Time-Matched Placebo-Corrected Change From Baseline of the QT Interval Corrected According to Fridericia (QTcF) at Specified Time Points Posttreatment With Moxifloxacin
    date_rangeTime Frame:
    0 h (pre-dose) and 48 h post-dose
  • Time-Matched Placebo-Corrected Change From Baseline of the QT Interval Corrected According to Bazett (QTcB) at Specified Time Points Posttreatment With Finerenone and Moxifloxacin
    date_rangeTime Frame:
    0 h (pre-dose) and 48 h post-dose
  • Time-Matched Placebo-Corrected Change From Baseline of the QT Interval According to Individual Correction Formula (QTcI) at Specified Time Points Post-treatment With Finerenone and Moxifloxacin
    date_rangeTime Frame:
    0 h (pre-dose) and 48 h post-dose
  • Time-Matched Placebo-Corrected Change From Baseline of the QT Interval Uncorrected at Specified Time Points Post-treatment With Finerenone and Moxifloxacin
    date_rangeTime Frame:
    0 h (pre-dose) and 48 h post-dose
  • Time-Matched Placebo-Corrected Change From Baseline of Ventricular Rate at Specified Time Points Post-treatment With Finerenone and Moxifloxacin
    date_rangeTime Frame:
    0 h (pre-dose) and 48 h post-dose

Trial design

A randomized, double-blinded, double-dummy, 4 way crossover, placebo- and active-controlled Phase I study to investigate the influence of single doses (20 mg and 80 mg) of finerenone on the QTc interval in healthy male and female subjects
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Other
Allocation
Randomized
Blinding
N/A
Assignment
Crossover Assignment
Trial Arms
4