Trial Condition(s):
Clinical Pharmacology
Drug-drug interaction study to investigate the effect of finerenone on repaglinide
Bayer Identifier:
16541
ClinicalTrials.gov Identifier:
Not Available
EudraCT Number:
EU CT Number:
Not Available
Trial Purpose
The primary objective of this study is
- to investigate the influence of a single oral dose of finerenone 20 mg on the pharmacokinetics of 0.5 mg repaglinide, given as a single oral dose in combination with 20 mg finerenone or 3 h after administration of 20 mg finerenone, in comparison to 0.5 mg repaglinide given alone.
The secondary objective of this study is:
- to investigate the influence of a single oral dose of finerenone 20 mg on the pharmacodynamics (blood glucose concentration), safety and tolerability of 0.5 mg repaglinide, given as a single oral dose in combination with 20 mg finerenone or 3 h after administration of 20 mg finerenone, in comparison to 0.5 mg repaglinide given alone.
Inclusion Criteria
- Healthy white male subjects aged between 18 and 45 years (inclusive) with a body mass index ≥18 and ≤29.9 kg/m².
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 Wuppertal, Germany, 42113 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Trial Design
Randomized, open-label, non-placebo-controlled, threefold cross-over study to investigate the effect of a single dose of 20 mg finerenone given concomitantly or 3 hours before repaglinide on the pharmacokinetics, safety and tolerability of a single oral dose of 0.5 mg repaglinide in comparison to 0.5 mg repaglinide alone in healthy male subjects
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Other
Allocation:
Randomized
Blinding:
N/A
Assignment:
Crossover Assignment
Trial Arms:
6
Primary Outcome
- Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC) of Repaglinide in Plasma After Single DoseTimeframe: 0 (pre-dose) to 24 h post-dose on Day 0
- Maximum Observed Drug Concentration (Cmax) of Repaglinide in Plasma After a Single DoseTimeframe: 0 (pre-dose) to 24 h post-dose on Day 0
Secondary Outcome
- Blood glucose concentrationTimeframe:
- Number of participants with adverse eventsTimeframe: From start of study treatment up to follow-up visit at least 7 days after last study drug administered
Additional Information
Not Available
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