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Finerenone: intact

Phase 1

Undisclosed | Small Molecules | Other |Bayer AG|Trials Updated: Apr 24, 2017

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment16

FDA Designations

No designations recorded

Finerenone: intact clinical trials

Finerenone: intact · 1 trial · 1 indication

Phase 1 1
NCT02957396Study of Finerenone to Investigate a Paediatric Formulation in Healthy Male SubjectsPharmacokinetics
COMPLETED16 Analytics
PHASE1COMPLETED
Study of Finerenone to Investigate a Paediatric Formulation in Healthy Male Subjects
PharmacokineticsUnlock trial analytics

Study Endpoints

Primary Endpoints

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 Endpoints

Number of patients with adverse events as a measure of safety and tolerability
Up to 4 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeOTHER

Treatment Arms

ArmTypeDescription
Adult formulation: Finerenone tablet_FastingACTIVE_COMPARATORSingle oral dose of 20 mg intact finerenone tablet fasting
Adult formulation: Finerenone crushed tablet_FastingEXPERIMENTALSingle oral dose of 20 mg crushed and resuspended finerenone tablet fasting
Pediatric formulation: Finerenone suspension_FastingEXPERIMENTALSingle oral dose of 20 mg finerenone suspension fasting
Pediatric formulation: Finerenone suspension_FedEXPERIMENTALSingle oral dose of 20 mg finerenone suspension fed; 30 minutes after start of an American breakfast

Interventions

NameTypeDescription
Finerenone (BAY94-8862): 20 mg intact tabletDRUG20 mg intact finerenone immediate-release tablet; single dose in the fasting condition
Finerenone (BAY94-8862): 20 mg crushed and resuspended tabletDRUG20 mg crushed and resuspended finerenone immediate-release tablet; single dose in the fasting condition
Finerenone (BAY94-8862): 20 mg suspensionDRUG20 mg finerenone suspension; single dose in the fasting condition or in the fed condition
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Eligibility Criteria

Age Range18 Years to 45 Years
SexMALE
Healthy VolunteersYes
Study Sites1

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 relev...

Countries:Germany
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Frequently asked questions about Finerenone: intact

What is finerenone?

Finerenone is a small molecule drug developed by Bayer AG under the ticker BAYRY. It is being studied in clinical development, with a Phase 1 trial completed in healthy male volunteers. The specific medical conditions it is intended to treat have not been disclosed.

Who makes finerenone?

Finerenone is developed by Bayer AG, which trades under the ticker BAYRY. Bayer sponsored the Phase 1 study of the drug, a pharmacokinetic trial conducted in Germany in healthy male subjects.

What phase is finerenone in?

Finerenone is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are currently listed. The completed study was a randomized, active-controlled pharmacokinetic trial in healthy male volunteers.

What clinical trials is finerenone in?

Finerenone has been studied in one completed clinical trial, NCT02957396, titled Study of Finerenone to Investigate a Paediatric Formulation in Healthy Male Subjects. The Phase 1 trial enrolled 16 healthy male volunteers aged 18 years and older in Germany and used an active-controlled, randomized design.

Is finerenone the same as BAY94-8862?

Yes, finerenone is also known as BAY94-8862. The 20 mg intact tablet is one formulation of the drug. Bayer AG developed finerenone under the code BAY94-8862, and the two names refer to the same small molecule compound.