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

Phase 1

Completed

• Conditions: Pharmacokinetics

• Registration Number: NCT02956109
• Lead Sponsor: Bayer

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-11-03
• Study First Submitted QC: 2016-11-03
• Study First Posted: 2016-11-04
• Study Start: 2016-11-16
• Primary Completion: 2016-12-22
• Study Completion: 2017-03-17
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-06
• Last Update Posted: 2017-07-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 16

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
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
Taste of oro-dispersible tablets assessed by questionnaire	Up to 5 minutes after drug administration
Appearance 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

Name	Time	Method
Number of patients with adverse events as a measure of safety and tolerability	Up to 3 weeks