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

NCT02957396 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2017-04-24

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 novel liquid formulation for the treatment of children in comparison to the adult tablet formulation.

Conditions

  • Pharmacokinetics

Interventions

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

Sponsors & Collaborators

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
2016-11-17
Primary Completion
2017-01-13
Completion
2017-03-01

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 NCT02957396 on ClinicalTrials.gov