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BAY1214784

Phase 1

Clinical Trials, Phase I as Topic | Small molecule | Neurology |Bayer AG|Last Updated: Mar 11, 2015

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment48

FDA Designations

No designations recorded

Clinical trial landscape

BAY1214784 · 1 trial · 1 indication

Phase 1 1
NCT02212080First in Human Study in Healthy Volunteers to Investigate the Safety, Tolerability and Pharmacokinetics of BAY1214784Clinical Trials, Phase I as Topic
COMPLETED48 Analytics
PHASE1COMPLETED
First in Human Study in Healthy Volunteers to Investigate the Safety, Tolerability and Pharmacokinetics of BAY1214784
Clinical Trials, Phase I as TopicUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of adverse events
Up to 2 weeks after dosing
Severity of adverse events (mild, moderate, severe)
Up to 2 weeks after dosing
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
BAY1214784EXPERIMENTALDose 1 to 7 of BAY1214784
PlaceboPLACEBO_COMPARATORPlacebo Dose 1 to 7 of BAY1214784

Interventions

NameTypeDescription
BAY1214784DRUGEscalating doses of 5, 20, 60, 150, 300, 600, 1000 mg of BAY1214784; single dose administration; liquid dosage form
PlaceboDRUGDose 1, 2,3, 4, 5, 6 and 7 of respective placebos; single dose administration; liquid dosage form
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Eligibility Criteria

Age Range45 Years to 65 Years
SexFEMALE
Healthy VolunteersYes
Study Sites2

Inclusion Criteria: * Healthy female subjects * Age 45 to 65 years * Body mass index (BMI) above/equal 20 and below/equal 30 kg/m2 * Postmenopausal state Exclusion Criteria: * Incompletely cured pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimi...

Countries:Germany
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Frequently asked questions about BAY1214784

What is BAY1214784 used for?

BAY1214784 is an investigational small molecule being studied in neurology. It was evaluated in a first-in-human Phase 1 clinical trial in healthy volunteers to assess its safety, tolerability, and pharmacokinetics. The drug is not approved and remains in clinical development.

Who makes BAY1214784?

BAY1214784 is being developed by Bayer AG, a multinational pharmaceutical company. Bayer's stock is traded over-the-counter under the ticker BAYRY.

What phase is BAY1214784 in?

BAY1214784 is in Phase 1 clinical development. A single Phase 1 trial has been completed, and the drug remains investigational. It has not been approved by regulatory authorities.

What clinical trials is BAY1214784 in?

BAY1214784 has one completed clinical trial, registered as NCT02212080. This was a first-in-human study in healthy volunteers in Germany, designed to investigate the drug's safety, tolerability, and pharmacokinetics. The trial enrolled 48 female participants aged 45 years and older.

Is BAY1214784 being studied in healthy volunteers?

Yes, BAY1214784 was studied in healthy volunteers. The completed Phase 1 trial, NCT02212080, enrolled 48 healthy female participants in Germany. The study was randomized, double-blind, and placebo-controlled, focusing on safety, tolerability, and pharmacokinetics.