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

Sponsor
Bayer
Study ID
NCT02956109
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 single oral dose of finerenone (1.25 mg tablet and 5 x 0.25 mg tablets) using a novel orodispersible tablet formulation for the treatment of children, in comparison to the adult tablet formulation.

Key Dates

Start date
Nov 16, 2016
Status verified
Jul 2017
Primary completion
Dec 22, 2016
Completion
Mar 17, 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 10 mg finerenone tablet fasting
  • Experimental: Pediatric formulation: 5X 0.25 mg Finerenone ODT_Fasting
    Single oral dose of 5 x 0.25 mg finerenone oro-dispersible tablets fasting
  • Experimental: Pediatric formulation: 1.25 mg Finerenone ODT_Fasting
    Single oral dose of 1.25 mg finerenone oro-dispersible tablet fasting
  • Experimental: Pediatric formulation: 1.25 mg Finerenone ODT_Fed
    Single oral dose of 1.25 mg finerenone oro-dispersible tablet 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 ]

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