check_circleStudy Completed

Clinical Pharmacology

Bayer Identifier:

16535

ClinicalTrials.gov Identifier:

Not Available

EudraCT Number:

2014-000752-28

EU CT Number:

Not Available
Absolute bioavailability study

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.

Key Participants Requirements

Sex

Male

Age

18 - 46 Years
  • - Healthy male white subjects between 18 and 46 years of age (inclusive) and a body mass index ≥ 18 and ≤ 29.9 kg/m^2

  • -

Trial summary

Enrollment Goal
28
Trial Dates
July 2014 - January 2015
Phase
Phase 1
Could I Receive a placebo
No
Products
Finerenone (BAY94-8862)
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Completed
Mönchengladbach, 41061, Germany

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 Study
    date_rangeTime Frame:
    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 Study
    date_rangeTime Frame:
    0 h pre-dose to 72 h post-dose

Secondary Outcome

  • Number of participants with treatment emergent adverse events
    date_rangeTime Frame:
    From the start of study treatment until 3 days after treatment with study medication, approximately 16 weeks

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