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

NCT ID: NCT02956109

Last Updated: 2017-07-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-11-16
• Study Completion Date: 2017-03-17

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Adult formulation: Finerenone tablet_Fasting

Single oral dose of 10 mg finerenone tablet fasting

Group Type: ACTIVE_COMPARATOR

Finerenone (BAY94-8862): 1 0mg tablet

Intervention Type: DRUG

10 mg finerenone immediate-release tablet; single dose in the fasting condition

Pediatric formulation: 5X 0.25 mg Finerenone ODT_Fasting

Single oral dose of 5 x 0.25 mg finerenone oro-dispersible tablets fasting

Group Type: EXPERIMENTAL

Finerenone (BAY94-8862): 5 X 0.25 mg oro-dispersible tablets

Intervention Type: DRUG

5 x 0.25 mg (1.25 mg) oro-dispersible tablets; single dose in the fasting condition

Pediatric formulation: 1.25 mg Finerenone ODT_Fasting

Single oral dose of 1.25 mg finerenone oro-dispersible tablet fasting

Group Type: EXPERIMENTAL

Finerenone (BAY94-8862): 1.25 mg oro-dispersible tablet

Intervention Type: DRUG

1.25 mg finerenone oro-dispersible tablets; single dose in the fasting condition or in the fed condition

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

Group Type: EXPERIMENTAL

Finerenone (BAY94-8862): 1.25 mg oro-dispersible tablet

Intervention Type: DRUG

1.25 mg finerenone oro-dispersible tablets; single dose in the fasting condition or in the fed condition

Interventions

Finerenone (BAY94-8862): 1 0mg tablet

10 mg finerenone immediate-release tablet; single dose in the fasting condition

Intervention Type: 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

Intervention Type: 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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Healthy male subjects
• Age: 18 to 45 years (inclusive)
• Body mass index (BMI) : ≥ 18 and ≤ 29.9 kg/m²
• Race: White

Exclusion Criteria

• Subjects with conspicuous findings in medical history and pre-study examination in the opinion of the investigator
• A history of relevant diseases of vital organs, of the central nervous system or other organs
• Known renal or liver insufficiency
• Subjects with diagnosed malignancy, psychiatric disorders, or thyroid disorders (evaluated by medical history, physical examination, clinical symptoms, and assessment of thyroid stimulating hormone at screening)
• Medical disorder that would impair the subject's ability to complete the study in the opinion of the investigator
• Incompletely cured pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination and effects of the study drugs will not be normal
• Relevant diseases within the last 4 weeks prior to the first study drug administration
• Smoking more than 10 cigarettes daily and/ or inability to refrain from smoking on the profile days until 8 h after administration
• Vegetarian or special diets preventing the subjects from eating the standard meals during the study, especially the high-fat high-calorie American breakfast or reluctance to ingest it

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Bayer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

Mönchengladbach, North Rhine-Westphalia, Germany

Countries

Germany

Other Identifiers

2016-002895-29

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

18290

Identifier Type: -

Identifier Source: org_study_id