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

Bayer

Status and phase: Completed; Phase 1

Conditions: Pharmacokinetics

Treatments: Drug: Finerenone (BAY94-8862): 20 mg crushed and resuspended tablet; Drug: Finerenone (BAY94-8862): 20 mg suspension; Drug: Finerenone (BAY94-8862): 20 mg intact tablet

Study type: Interventional

Funder types: Industry

Identifiers

NCT02957396

16538

2016-002813-24 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 16 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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16 participants in 4 patient groups

Adult formulation: Finerenone tablet_Fasting

Active Comparator group

Description:

Single oral dose of 20 mg intact finerenone tablet fasting

Treatment:

Drug: Finerenone (BAY94-8862): 20 mg intact tablet

Adult formulation: Finerenone crushed tablet_Fasting

Experimental group

Description:

Single oral dose of 20 mg crushed and resuspended finerenone tablet fasting

Treatment:

Drug: Finerenone (BAY94-8862): 20 mg crushed and resuspended tablet

Pediatric formulation: Finerenone suspension_Fasting

Experimental group

Description:

Single oral dose of 20 mg finerenone suspension fasting

Treatment:

Drug: Finerenone (BAY94-8862): 20 mg suspension

Pediatric formulation: Finerenone suspension_Fed

Experimental group

Description:

Single oral dose of 20 mg finerenone suspension fed; 30 minutes after start of an American breakfast

Treatment:

Drug: Finerenone (BAY94-8862): 20 mg suspension