Trial Condition(s):
Pharmacokinetics
Study of finerenone to investigate a paediatric formulation in healthy male volunteers
Bayer Identifier:
18290
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
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 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.
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
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Investigative Site Mönchengladbach, Germany, 41061 | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
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
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Other
Allocation:
Randomized
Blinding:
Open Label
Assignment:
Crossover Assignment
Trial Arms:
4
Primary Outcome
- Finerenone area under the plasma concentration vs. time curve (AUC)Timeframe: 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)Timeframe: 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 questionnaireTimeframe: Up to 5 minutes after drug administration
- Taste of oro-dispersible tablets assessed by questionnaireTimeframe: Up to 5 minutes after drug administration
- Texture of oro-dispersible tablets assessed by questionnaireTimeframe: Up to 5 minutes after drug administration
- Smell of oro-dispersible tablets assessed by questionnaireTimeframe: Up to 5 minutes after drug administration
- Overall impression of oro-dispersible tablets assessed by questionnaireTimeframe: Up to 5 minutes after drug administration
- Whether oro-dispersible tablets are palatable and swallowable assessed by questionnaireTimeframe: Up to 5 minutes after drug administration
Secondary Outcome
- Number of patients with adverse events as a measure of safety and tolerabilityTimeframe: Up to 3 weeks
Additional Information
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