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

Pharmacokinetics Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02956109
• Other study ID #: 18290
• Secondary ID: 2016-002895-29
• Status: Completed
• Phase: Phase 1
• First received: November 3, 2016
• Last updated: July 6, 2017
• Start date: November 16, 2016
• Est. completion date: March 17, 2017

Study information

• Verified date: July 2017
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: March 17, 2017
• Est. primary completion date: December 22, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Pharmacokinetics

Intervention

Drug:
• Finerenone (BAY94-8862): 1 0mg tablet
10 mg finerenone immediate-release tablet; single dose in the fasting condition
• Finerenone (BAY94-8862): 5 X 0.25 mg oro-dispersible tablets
5 x 0.25 mg (1.25 mg) oro-dispersible tablets; single dose in the fasting condition
• Finerenone (BAY94-8862): 1.25 mg oro-dispersible tablet
1.25 mg finerenone oro-dispersible tablets; single dose in the fasting condition or in the fed condition

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Finerenone area under the plasma concentration vs. time curve (AUC)		Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5. 3, 4, 6, 8, 12, 15 and 24 hours
Primary	Finerenone maximum plasma concentration (Cmax)		Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5. 3, 4, 6, 8, 12, 15 and 24 hours
Primary	Appearance of oro-dispersible tablets assessed by questionnaire		Up to 5 minutes after drug administration
Primary	Taste of oro-dispersible tablets assessed by questionnaire		Up to 5 minutes after drug administration
Primary	Texture of oro-dispersible tablets assessed by questionnaire		Up to 5 minutes after drug administration
Primary	Smell of oro-dispersible tablets assessed by questionnaire		Up to 5 minutes after drug administration
Primary	Overall impression of oro-dispersible tablets assessed by questionnaire		Up to 5 minutes after drug administration
Primary	Whether oro-dispersible tablets are palatable and swallowable assessed by questionnaire		Up to 5 minutes after drug administration
Secondary	Number of patients with adverse events as a measure of safety and tolerability		Up to 3 weeks

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