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

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

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.

Study Overview

• Status: Completed
• Conditions: Pharmacokinetics
• Intervention / Treatment: Drug: Finerenone (BAY94-8862): 1 0mg tablet; Drug: Finerenone (BAY94-8862): 5 X 0.25 mg oro-dispersible tablets; Drug: Finerenone (BAY94-8862): 1.25 mg oro-dispersible tablet

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Phase 1

Contacts and Locations

Study Locations

• Germany
  • Nordrhein-Westfalen
    • Mönchengladbach, Nordrhein-Westfalen, Germany, 41061

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Adult formulation: Finerenone tablet_Fasting; Single oral dose of 10 mg finerenone tablet fasting	Drug: Finerenone (BAY94-8862): 1 0mg tablet; 10 mg finerenone immediate-release tablet; single dose in the fasting condition
Experimental: Pediatric formulation: 5X 0.25 mg Finerenone ODT_Fasting; Single oral dose of 5 x 0.25 mg finerenone oro-dispersible tablets fasting	Drug: 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
Experimental: Pediatric formulation: 1.25 mg Finerenone ODT_Fasting; Single oral dose of 1.25 mg finerenone oro-dispersible tablet fasting	Drug: 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
Experimental: Pediatric formulation: 1.25 mg Finerenone ODT_Fed; Single oral dose of 1.25 mg finerenone oro-dispersible tablet fed; 30 minutes after start of an American breakfast	Drug: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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
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
Appearance of oro-dispersible tablets assessed by questionnaire	Up to 5 minutes after drug administration
Taste of oro-dispersible tablets assessed by questionnaire	Up to 5 minutes after drug administration
Texture of oro-dispersible tablets assessed by questionnaire	Up to 5 minutes after drug administration
Smell of oro-dispersible tablets assessed by questionnaire	Up to 5 minutes after drug administration
Overall impression of oro-dispersible tablets assessed by questionnaire	Up to 5 minutes after drug administration
Whether oro-dispersible tablets are palatable and swallowable assessed by questionnaire	Up to 5 minutes after drug administration

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of patients with adverse events as a measure of safety and tolerability	Up to 3 weeks

Collaborators and Investigators

• Sponsor: Bayer

Study record dates

Study Major Dates

• Study Start (Actual): November 16, 2016
• Primary Completion (Actual): December 22, 2016
• Study Completion (Actual): March 17, 2017

Study Registration Dates

• First Submitted: November 3, 2016
• First Submitted That Met QC Criteria: November 3, 2016
• First Posted (Estimate): November 4, 2016

Study Record Updates

• Last Update Posted (Actual): July 11, 2017
• Last Update Submitted That Met QC Criteria: July 6, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: 18290; 2016-002895-29 (EudraCT Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No