check_circleStudy Completed

Pharmacokinetics

Bayer Identifier:

16538

ClinicalTrials.gov Identifier:

NCT02957396

EudraCT Number:

2016-002813-24

EU CT Number:

Not Available
Study of finerenone to investigate a paediatric formulation in healthy male subjects

Trial purpose

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 novel liquid formulation for the treatment of children in comparison to the adult tablet formulation.

Key Participants Requirements

Sex

Male

Age

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

  • - 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

Trial summary

Enrollment Goal
16
Trial Dates
November 2016 - March 2017
Phase
Phase 1
Could I Receive a placebo
No
Products
Finerenone (BAY94-8862)
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Completed
Berlin, 13353, Germany

Primary Outcome

  • Finerenone area under the plasma concentration vs. time curve (AUC)
    date_rangeTime Frame:
    Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5. 3, 4, 6, 8, 12, 15 and 24 hours
    enhanced_encryption
    Safety Issue:
    No
  • Finerenone maximum plasma concentration (Cmax)
    date_rangeTime Frame:
    Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5. 3, 4, 6, 8, 12, 15 and 24 hours
    enhanced_encryption
    Safety Issue:
    No
  • Appearance of oro-dispersible tablets assessed by questionnaire
    date_rangeTime Frame:
    Up to 5 minutes after drug administration
    enhanced_encryption
    Safety Issue:
    No
  • Taste of oro-dispersible tablets assessed by questionnaire
    date_rangeTime Frame:
    Up to 5 minutes after drug administration
    enhanced_encryption
    Safety Issue:
    No
  • Texture of oro-dispersible tablets assessed by questionnaire
    date_rangeTime Frame:
    Up to 5 minutes after drug administration
    enhanced_encryption
    Safety Issue:
    No
  • Smell of oro-dispersible tablets assessed by questionnaire
    date_rangeTime Frame:
    Up to 5 minutes after drug administration
    enhanced_encryption
    Safety Issue:
    No
  • Overall impression of oro-dispersible tablets assessed by questionnaire
    date_rangeTime Frame:
    Up to 5 minutes after drug administration
    enhanced_encryption
    Safety Issue:
    No
  • Whether oro-dispersible tablets are palatable and swallowable assessed by questionnaire
    date_rangeTime Frame:
    Up to 5 minutes after drug administration
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Number of patients with adverse events as a measure of safety and tolerability
    date_rangeTime Frame:
    Up to 4 weeks
    enhanced_encryption
    Safety Issue:
    Yes

Trial design

Relative bioavailability study to investigate the pharmacokinetics, safety and tolerability of a single oral dose of finerenone 20 mg as suspension (pediatric formulation), intact tablet and crushed tablet (adult formulation) in the fasting condition, and to investigate the effect of a high fat, high calorie meal on the suspension in healthy male subjects in a randomized, open-label, four-fold crossover design.
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Other
Allocation
Randomized
Blinding
Open Label
Assignment
Crossover Assignment
Trial Arms
4