Study Completed

Pharmacokinetics

Bayer Identifier:

18290

ClinicalTrials.gov Identifier:

NCT02956109

EudraCT Number:

2016-002895-29

EU CT Number:

Not Available

Study of finerenone to investigate a paediatric formulation in healthy male volunteers

Trial purpose

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.

Key Participants Requirements

Sex

Male

Age

18 - 45 Years

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 summary

Enrollment Goal

Trial Dates

November 2016 - March 2017

Phase

Phase 1

Could I Receive a placebo

Products

Finerenone (BAY94-8862)

Accepts Healthy Volunteer

Yes

Where to participate

Status	Institution	Location
Completed		Mönchengladbach, 41061, Germany

Primary Outcome

Finerenone area under the plasma concentration vs. time curve (AUC)
Time Frame:
Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5. 3, 4, 6, 8, 12, 15 and 24 hours
Safety Issue:
No
Finerenone maximum plasma concentration (Cmax)
Time Frame:
Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5. 3, 4, 6, 8, 12, 15 and 24 hours
Safety Issue:
No
Appearance of oro-dispersible tablets assessed by questionnaire
Time Frame:
Up to 5 minutes after drug administration
Safety Issue:
No
Taste of oro-dispersible tablets assessed by questionnaire
Time Frame:
Up to 5 minutes after drug administration
Safety Issue:
No
Texture of oro-dispersible tablets assessed by questionnaire
Time Frame:
Up to 5 minutes after drug administration
Safety Issue:
No
Smell of oro-dispersible tablets assessed by questionnaire
Time Frame:
Up to 5 minutes after drug administration
Safety Issue:
No
Overall impression of oro-dispersible tablets assessed by questionnaire
Time Frame:
Up to 5 minutes after drug administration
Safety Issue:
No
Whether oro-dispersible tablets are palatable and swallowable assessed by questionnaire
Time Frame:
Up to 5 minutes after drug administration
Safety Issue:
No

Secondary Outcome

Number of patients with adverse events as a measure of safety and tolerability
Time Frame:
Up to 3 weeks
Safety Issue:
Yes

Trial design

Relative bioavailability study to investigate the pharmacokinetics, safety and tolerability of single oral doses of finerenone 1.25 mg and 5 x 0.25 mg orodispersible tablet (pediatric formulation) in comparison to 10 mg tablet (adult formulation) in the fasting condition and to investigate the effect of a high fat, high calorie meal on 1.25 mg oro-dispersible tablet in healthy male subjects in a randomized, open-label, four-fold crossover design

Trial Type

Interventional

Intervention Type

Drug

Trial Purpose

Other

Allocation

Randomized

Blinding

Open Label

Assignment

Crossover Assignment

Trial Arms

Additional Information

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