Trial Condition(s):
Clinical Pharmacology
Drug-drug interaction study with midazolam
Bayer Identifier:
15111
ClinicalTrials.gov Identifier:
Not Available
EudraCT Number:
EU CT Number:
Not Available
Trial Purpose
The primary objective of the study was to assess the influence of multiple doses of 20 mg finerenone administered once daily for 10 days on the pharmacokinetics of a single oral dose of 7.5 mg midazolam.
The secondary objective of the study was to assess the influence of multiple doses of 20 mg finerenone administered once daily for 10 days on the safety and tolerability of a single oral dose of midazolam.
Inclusion Criteria
- Healthy male subjects between 18 and 45 years of age (inclusive) and with a body mass index ≥18 and ≤29.9 kg/m^2
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 | |
|---|---|
Locations Investigative Site Berlin, Germany, 13353 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Trial Design
Single-center, randomized, non-blinded, non-placebo-controlled, two-fold cross-over study to investigate the influence of multiple doses of 20 mg OD finerenone on pharmacokinetics, safety and tolerability of a single oral dose of 7.5 mg midazolam in comparison to a single dose of 7.5 mg midazolam alone in healthy male subjects
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Other
Allocation:
Randomized
Blinding:
N/A
Assignment:
Crossover Assignment
Trial Arms:
2
Primary Outcome
- Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC) of Midazolam in PlasmaTimeframe: Pre-dose to 24 hours post-dose
- Maximum Observed Concentration (Cmax) of Midazolam in PlasmaTimeframe: Pre-dose to 24 hours post-dose
Secondary Outcome
- Number of Subjects With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)Timeframe: From start of study drug administration until 3 days after the last dose of study treatment
Additional Information
Not Available
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