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

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ClinicalTrials.gov Identifier: NCT02956109
Recruitment Status : Completed
First Posted : November 4, 2016
Last Update Posted : July 11, 2017
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Pharmacokinetics 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 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: 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
Actual Study Start Date : November 16, 2016
Actual Primary Completion Date : December 22, 2016
Actual Study Completion Date : March 17, 2017

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




Primary Outcome Measures :
  1. Finerenone area under the plasma concentration vs. time curve (AUC) [ Time Frame: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5. 3, 4, 6, 8, 12, 15 and 24 hours ]
  2. Finerenone maximum plasma concentration (Cmax) [ Time Frame: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5. 3, 4, 6, 8, 12, 15 and 24 hours ]
  3. Appearance of oro-dispersible tablets assessed by questionnaire [ Time Frame: Up to 5 minutes after drug administration ]
  4. Taste of oro-dispersible tablets assessed by questionnaire [ Time Frame: Up to 5 minutes after drug administration ]
  5. Texture of oro-dispersible tablets assessed by questionnaire [ Time Frame: Up to 5 minutes after drug administration ]
  6. Smell of oro-dispersible tablets assessed by questionnaire [ Time Frame: Up to 5 minutes after drug administration ]
  7. Overall impression of oro-dispersible tablets assessed by questionnaire [ Time Frame: Up to 5 minutes after drug administration ]
  8. Whether oro-dispersible tablets are palatable and swallowable assessed by questionnaire [ Time Frame: Up to 5 minutes after drug administration ]

Secondary Outcome Measures :
  1. Number of patients with adverse events as a measure of safety and tolerability [ Time Frame: Up to 3 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02956109


Locations
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Germany
Mönchengladbach, Nordrhein-Westfalen, Germany, 41061
Sponsors and Collaborators
Bayer
Investigators
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Study Director: Bayer Study Director Bayer

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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT02956109     History of Changes
Other Study ID Numbers: 18290
2016-002895-29 ( EudraCT Number )
First Posted: November 4, 2016    Key Record Dates
Last Update Posted: July 11, 2017
Last Verified: July 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No