Trial Condition(s):
Clinical Pharmacology
Drug-drug interaction study to investigate the effect of gemfibrozil on finerenone
Bayer Identifier:
15112
ClinicalTrials.gov Identifier:
Not Available
EudraCT Number:
EU CT Number:
Not Available
Trial Purpose
The primary objective of the study was to investigate the influence of multiple oral doses of gemfibrozil 600 mg bid on the pharmacokinetics of 10 mg finerenone.
The secondary objective of the study was to assess the safety and tolerability of 10 mg finerenone given as a single oral dose on the background of gemfibrozil in comparison to 10 mg finerenone given alone.
Inclusion Criteria
- Healthy white male subjects between 18 and 45 years (inclusive) of age and a body mass index between 18 and 29.9 kg/m2 (both inclusive)
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 Mannheim, Germany, 68167 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Trial Design
Randomized, non-blinded, non-placebo-controlled, two-fold cross-over study to investigate the influence of multiple doses of 600 mg gemfibrozil twice-daily on the pharmacokinetics, safety and tolerability of a single oral dose of 10 mg finerenone in comparison to a single dose of 10 mg of finerenone 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 Finerenone in PlasmaTimeframe: Treatment A and B: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 15, 24, 36, 48 hours postdose
- Maximum Observed Drug Concentration (Cmax) of Finerenone in PlasmaTimeframe: Treatment A and B: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 15, 24, 36, 48 hours post dose
Secondary Outcome
- Number of subjects with treatment emergent adverse events (TEAEs)Timeframe: From the start of study treatment up to 14 days after the last study drug administration
Additional Information
Not Available
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