NCT02956109

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

Relative Bioavailability Study to Investigate the Pharmacokinetics, Safety and Tolerability of Single Oral Doses of Finerenone 1.25 mg and 5 x 0.25 mg Orodispersible Tablet (Pediatric Formulation) in Comparison to 10 mg Tablet (Adult Formulation) in the Fasting Condition and to Investigate the Effect of a High Fat, High Calorie Meal on 1.25 mg Oro-dispersible Tablet 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 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.

Conditions

• Pharmacokinetics

Interventions

Type	Name	Description
DRUG	Finerenone (BAY94-8862): 1 0mg tablet	10 mg finerenone immediate-release tablet; single dose in the fasting condition
DRUG	Finerenone (BAY94-8862): 5 X 0.25 mg oro-dispersible tablets	5 x 0.25 mg (1.25 mg) oro-dispersible tablets; single dose in the fasting condition
DRUG	Finerenone (BAY94-8862): 1.25 mg oro-dispersible tablet	1.25 mg finerenone oro-dispersible tablets; single dose in the fasting condition or in the fed condition

Timeline

• Start date: 2016-11-16
• Primary completion: 2016-12-22
• Completion: 2017-03-17
• First posted: 2016-11-04
• Last updated: 2017-07-11

Locations

1 site across 1 country: Germany