Trial Condition(s):
Clinical Pharmacology
Investigation of the effect of finerenone on the QTc interval
Bayer Identifier:
15113
ClinicalTrials.gov Identifier:
Not Available
EudraCT Number:
EU CT Number:
Not Available
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)
Inclusion Criteria
- Healthy male or female white subjects between 18 and 55 years of age
Exclusion Criteria
No Exclusion Criteria Available
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | |
|---|---|---|
Locations Investigative Site Mannheim, Germany, 68167 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
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
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 FinerenoneTimeframe: 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 PlasmaTimeframe: 0 h (pre-dose) to 48 h post-dose
- Maximum Observed Drug Concentration Divided by Dose (Cmax/D) of Finerenone and its Metabolites in PlasmaTimeframe: 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 MoxifloxacinTimeframe: 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 MoxifloxacinTimeframe: 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 MoxifloxacinTimeframe: 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 MoxifloxacinTimeframe: 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 MoxifloxacinTimeframe: 0 h (pre-dose) and 48 h post-dose
Additional Information
Not Available
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