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

Bayer

Status and phase: Completed; Phase 1

Conditions: Pharmacokinetics

Treatments: Drug: Finerenone (BAY94-8862): 1.25 mg oro-dispersible tablet; Drug: Finerenone (BAY94-8862): 1 0mg tablet; Drug: Finerenone (BAY94-8862): 5 X 0.25 mg oro-dispersible tablets

Study type: Interventional

Funder types: Industry

Identifiers

NCT02956109

2016-002895-29 (EudraCT Number)

18290

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 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.

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 10 mg finerenone tablet fasting

Treatment:

Drug: Finerenone (BAY94-8862): 1 0mg tablet

Pediatric formulation: 5X 0.25 mg Finerenone ODT_Fasting

Experimental group

Description:

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

Treatment:

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

Pediatric formulation: 1.25 mg Finerenone ODT_Fasting

Experimental group

Description:

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

Treatment:

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

Pediatric formulation: 1.25 mg Finerenone ODT_Fed

Experimental group

Description:

Single oral dose of 1.25 mg finerenone oro-dispersible tablet fed; 30 minutes after start of an American breakfast

Treatment:

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