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

NCT02956109 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2017-07-11

No results posted yet for this study

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

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

Sponsors & Collaborators

Principal Investigators

  • Bayer Study Director · Bayer

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-11-16
Primary Completion
2016-12-22
Completion
2017-03-17

Countries

  • Germany

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02956109 on ClinicalTrials.gov