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

NCT02956109 | Completed Phase 1

• 2 other identifiers: 182902016-002895-29
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Pharmacokinetics

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (1)

• Number of patients with adverse events as a measure of safety and tolerability

  Up to 3 weeks

Study Arms (4)

Adult formulation: Finerenone tablet_Fasting

ACTIVE COMPARATOR

Single oral dose of 10 mg finerenone tablet fasting

Drug: Finerenone (BAY94-8862): 1 0mg tablet

Pediatric formulation: 5X 0.25 mg Finerenone ODT_Fasting

EXPERIMENTAL

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

Pediatric formulation: 1.25 mg Finerenone ODT_Fasting

EXPERIMENTAL

Single oral dose of 1.25 mg finerenone oro-dispersible tablet fasting

Drug: Finerenone (BAY94-8862): 1.25 mg oro-dispersible tablet

Pediatric formulation: 1.25 mg Finerenone ODT_Fed

EXPERIMENTAL

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

Interventions

Finerenone (BAY94-8862): 1 0mg tablet DRUG

10 mg finerenone immediate-release tablet; single dose in the fasting condition

Adult formulation: Finerenone tablet_Fasting

Finerenone (BAY94-8862): 5 X 0.25 mg oro-dispersible tablets DRUG

5 x 0.25 mg (1.25 mg) oro-dispersible tablets; single dose in the fasting condition

Pediatric formulation: 5X 0.25 mg Finerenone ODT_Fasting

Finerenone (BAY94-8862): 1.25 mg oro-dispersible tablet DRUG

1.25 mg finerenone oro-dispersible tablets; single dose in the fasting condition or in the fed condition

Pediatric formulation: 1.25 mg Finerenone ODT_Fasting; Pediatric formulation: 1.25 mg Finerenone ODT_Fed

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male subjects
• Age: 18 to 45 years (inclusive)
• Body mass index (BMI) : ≥ 18 and ≤ 29.9 kg/m²
• Race: White

You may not qualify if:

• 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

Sponsors & Collaborators

• Bayer: lead

Study Sites (1)

Unknown Facility

Mönchengladbach, North Rhine-Westphalia, 41061, Germany

Location

MeSH Terms

Interventions

finerenone; Tablets

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2016
• First Posted: November 4, 2016
• Study Start: November 16, 2016
• Primary Completion: December 22, 2016
• Study Completion: March 17, 2017
• Last Updated: July 11, 2017

Record last verified: 2017-07

Locations

DE (1)