Study of Finerenone to Investigate a Paediatric Formulation in Healthy Male Subjects
NCT ID: NCT02957396
Last Updated: 2017-04-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
16 participants
INTERVENTIONAL
2016-11-17
2017-03-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
OTHER
NONE
Study Groups
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Adult formulation: Finerenone tablet_Fasting
Single oral dose of 20 mg intact finerenone tablet fasting
Finerenone (BAY94-8862): 20 mg intact tablet
20 mg intact finerenone immediate-release tablet; single dose in the fasting condition
Adult formulation: Finerenone crushed tablet_Fasting
Single oral dose of 20 mg crushed and resuspended finerenone tablet fasting
Finerenone (BAY94-8862): 20 mg crushed and resuspended tablet
20 mg crushed and resuspended finerenone immediate-release tablet; single dose in the fasting condition
Pediatric formulation: Finerenone suspension_Fasting
Single oral dose of 20 mg finerenone suspension fasting
Finerenone (BAY94-8862): 20 mg suspension
20 mg finerenone suspension; single dose in the fasting condition or in the fed condition
Pediatric formulation: Finerenone suspension_Fed
Single oral dose of 20 mg finerenone suspension fed; 30 minutes after start of an American breakfast
Finerenone (BAY94-8862): 20 mg suspension
20 mg finerenone suspension; single dose in the fasting condition or in the fed condition
Interventions
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Finerenone (BAY94-8862): 20 mg intact tablet
20 mg intact finerenone immediate-release tablet; single dose in the fasting condition
Finerenone (BAY94-8862): 20 mg crushed and resuspended tablet
20 mg crushed and resuspended finerenone immediate-release tablet; single dose in the fasting condition
Finerenone (BAY94-8862): 20 mg suspension
20 mg finerenone suspension; single dose in the fasting condition or in the fed condition
Eligibility Criteria
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Inclusion Criteria
* Age: 18 to 45 years (inclusive)
* Body mass index (BMI) : ≥ 18 and ≤ 29.9 kg/m²
* Race: White
Exclusion Criteria
* 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
18 Years
45 Years
MALE
Yes
Sponsors
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Bayer
INDUSTRY
Responsible Party
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Locations
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Berlin, , Germany
Countries
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Other Identifiers
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2016-002813-24
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
16538
Identifier Type: -
Identifier Source: org_study_id
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