NCT02957396

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

Relative Bioavailability Study to Investigate the Pharmacokinetics, Safety and Tolerability of a Single Oral Dose of Finerenone 20 mg as Suspension (Pediatric Formulation), Intact Tablet and Crushed Tablet (Adult Formulation) in the Fasting Condition, and to Investigate the Effect of a High Fat, High Calorie Meal on the Suspension in Healthy Male Subjects in a Randomized, Open-label, Four-fold Crossover Design.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Bayer · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Pharmacokinetics

Interventions

Type	Name	Description
DRUG	Finerenone (BAY94-8862): 20 mg intact tablet	20 mg intact finerenone immediate-release tablet; single dose in the fasting condition
DRUG	Finerenone (BAY94-8862): 20 mg crushed and resuspended tablet	20 mg crushed and resuspended finerenone immediate-release tablet; single dose in the fasting condition
DRUG	Finerenone (BAY94-8862): 20 mg suspension	20 mg finerenone suspension; single dose in the fasting condition or in the fed condition

Timeline

• Start date: 2016-11-17
• Primary completion: 2017-01-13
• Completion: 2017-03-01
• First posted: 2016-11-07
• Last updated: 2017-04-24

Locations

1 site across 1 country: Germany