Trial Condition(s):
Clinical Pharmacology
Absolute bioavailability study
Bayer Identifier:
16535
ClinicalTrials.gov Identifier:
Not Available
EudraCT Number:
EU CT Number:
Not Available
Trial Purpose
The objectives of Part 1 with intravenous finerenone doses including 0.25 mg, 0.5 mg and 1.0 mg infused over 1 h were to investigate the safety, tolerability and pharmacokinetics of these treatments and to select an appropriate intravenous dose for Part 2.
The primary objective of Part 2 of this study, performed in a randomized, non-blinded, non-placebo controlled 2-way crossover design in 16 healthy male subjects, was to evaluate the absolute bioavailability of a single oral dose of a 5 mg IR tablet of finerenone in comparison to an intravenous infusion of 1 mg over 1 h (iv dose as planned and confirmed by results of Part 1) and to characterize the pharmacokinetics of finerenone after intravenous administration. The secondary objectives of Part 2 were to investigate the safety and tolerability.
Inclusion Criteria
- Healthy male white subjects between 18 and 46 years of age (inclusive) and 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 Mönchengladbach, Germany, 41061 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Trial Design
Study in healthy male subjects to assess the safety, tolerability and pharmacokinetics of an intravenous solution of finerenone (dose escalation and group comparison, part 1) and to investigate the absolute bioavailability of an oral dose of 5 mg finerenone (BAY 94 8862) in comparison to an intravenous solution of finerenone (planned dose 1 mg) administered over 1 hour (randomized, non-blinded, non-placebo-controlled, 2-way crossover design, part 2)
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Other
Allocation:
Randomized
Blinding:
Open Label
Assignment:
Sequential Assignment
Trial Arms:
5
Primary Outcome
- Area Under the Concentration Versus Time Curve From Zero to Infinity Divided by Dose (AUC/D) of Finerenone and its Metabolites (M-1, M-2 and M-3) During Part 2 of the StudyTimeframe: 0 hour (h) (pre-dose) to 72 h post-dose
- Maximum Observed Drug Concentration in Plasma Divided by Dose (Cmax/D) of Finerenone and its Metabolites (M-1, M-2 and M-3) During Part 2 of the StudyTimeframe: 0 h pre-dose to 72 h post-dose
Secondary Outcome
- Number of participants with treatment emergent adverse eventsTimeframe: From the start of study treatment until 3 days after treatment with study medication, approximately 16 weeks
Additional Information
Not Available
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