Study of Finerenone to Investigate a Paediatric Formulation in Healthy Male Subjects

Sponsor
Bayer
Study ID
NCT02957396
Phase
PHASE1
Status
Completed

Conditions

  • Pharmacokinetics

Eligibility Criteria

Sex
MALE
Age
18 Years - 45 Years
Healthy Volunteers
Accepted

Interventions

Study Details

Finerenone is developed for the treatment of diabetic kidney disease (adults) and chronic kidney disease (children). The purpose of the proposed trial is to test the pharmacokinetics of a novel liquid formulation for the treatment of children in comparison to the adult tablet formulation.

Key Dates

Start date
Nov 17, 2016
Status verified
Apr 2017
Primary completion
Jan 13, 2017
Completion
Mar 1, 2017

Study Design

Enrollment
16 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER

Arms

  • Active Comparator: Adult formulation: Finerenone tablet_Fasting
    Single oral dose of 20 mg intact finerenone tablet fasting
  • Experimental: Adult formulation: Finerenone crushed tablet_Fasting
    Single oral dose of 20 mg crushed and resuspended finerenone tablet fasting
  • Experimental: Pediatric formulation: Finerenone suspension_Fasting
    Single oral dose of 20 mg finerenone suspension fasting
  • Experimental: Pediatric formulation: Finerenone suspension_Fed
    Single oral dose of 20 mg finerenone suspension fed; 30 minutes after start of an American breakfast

Primary Outcome Measure

Finerenone area under the plasma concentration vs. time curve (AUC) [ Time Frame: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5. 3, 4, 6, 8, 12, 15 and 24 hours ]

Related Studies