Trial Condition(s):
Clinical Pharmacology
Finerenone / verapamil drug-drug interaction study
Bayer Identifier:
16910
ClinicalTrials.gov Identifier:
Not Available
EudraCT Number:
EU CT Number:
Not Available
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
Inclusion Criteria
- Healthy male white subjects between 18 and 45 years of age (inclusive) and 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 Berlin, Germany, 13353 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
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
Primary Outcome
- Area Under The Concentration Versus Time Curve From Zero To Infinity (AUC) of Finerenone In PlasmaTimeframe: 0 h (pre-dose) to 23 h post-dose
- Maximum Observed Concentration (Cmax) of Finerenone In PlasmaTimeframe: 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)Timeframe: From start of study treatment up to 3 days after the last drug administration in Period 2
Additional Information
Not Available
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