Clinical trial NCT02956109: Study of Finerenone to Investigate a Paediatric Formulation in Healthy Male Volunteers
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pharmacokinetics
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2016-11-04
Enrollment: 16
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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.


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

Primary outcomes:
measure: Finerenone area under the plasma concentration vs. time curve (AUC)
timeFrame: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5. 3, 4, 6, 8, 12, 15 and 24 hours
measure: Finerenone maximum plasma concentration (Cmax)
timeFrame: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5. 3, 4, 6, 8, 12, 15 and 24 hours
measure: Appearance of oro-dispersible tablets assessed by questionnaire
timeFrame: Up to 5 minutes after drug administration
measure: Taste of oro-dispersible tablets assessed by questionnaire
timeFrame: Up to 5 minutes after drug administration
measure: Texture of oro-dispersible tablets assessed by questionnaire
timeFrame: Up to 5 minutes after drug administration
measure: Smell of oro-dispersible tablets assessed by questionnaire
timeFrame: Up to 5 minutes after drug administration
measure: Overall impression of oro-dispersible tablets assessed by questionnaire
timeFrame: Up to 5 minutes after drug administration
measure: Whether oro-dispersible tablets are palatable and swallowable assessed by questionnaire
timeFrame: Up to 5 minutes after drug administration
Secondary outcomes:
measure: Number of patients with adverse events as a measure of safety and tolerability
timeFrame: Up to 3 weeks
Other outcomes:
Locations:
city: Mönchengladbach
country: Germany
state: Nordrhein-Westfalen
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: