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GSK424887

Phase 1

Depressive Disorder and Anxiety Disorders | Small molecule | Psychiatry |GSK plc|Last Updated: Aug 11, 2017

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials2
Total Enrollment80

FDA Designations

No designations recorded

Clinical trial landscape

GSK424887 · 2 trials · 1 indication

Phase 1 2
NCT01424384Emotional Processing in Healthy Volunteers in the Presence of an Investigational AnxiolyticDepressive Disorder and Anxiety Disorders
COMPLETED54 Analytics
NCT01059591First Study in Humans With GSK424887Depressive Disorder and Anxiety Disorders
COMPLETED26 Analytics
PHASE1COMPLETED
Emotional Processing in Healthy Volunteers in the Presence of an Investigational Anxiolytic
Depressive Disorder and Anxiety DisordersUnlock trial analytics
PHASE1COMPLETED
First Study in Humans With GSK424887
Depressive Disorder and Anxiety DisordersUnlock trial analytics

Study Endpoints

Primary Endpoints

Multiple emotional and psychometric battery of tests
< 1 day
Adverse Events, laboratory values, vital signs, ECGs
< 1 day
Adverse event monitoring, vital signs (blood pressure, heart rate, ECGs, clinical laboratory assessments (standard laboratory parameters); Area under the concentration-time curve (AUC), Maximum observed concentration (Cmax) , tmax
12 weeks

Secondary Endpoints

Brain receptor occupancy
2 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
CitalopramACTIVE_COMPARATORMarketed comparitor
Investigational Medicinal ProductEXPERIMENTALGSK424887
Placebo To Match TreatmentPLACEBO_COMPARATORPlacebo control
ActiveEXPERIMENTALGSK424887 once daily
PlaceboPLACEBO_COMPARATORPlacebo once daily

Interventions

NameTypeDescription
CitalopramDRUGNeurophysiological testing.
GSK424887DRUGNeurophysiological testing
Plactebo To MatchDRUGNeurophysiological testing
PlaceboDRUGPlacebo to match GSK424887 2mg, 10mg,50mg, 100mg capsule
PETRADIATIONEach subject will undergo 3 PET scans : one at Baseline and the others following dosing with GSK424887 at approximately 2h post-dose and aproximately 24 hours post-dose
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Eligibility Criteria

Age Range18 Years to 45 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Healthy males with no neurological, or history of psychiatric illness 2. Aged between 18 and 45 years 3. Agree to use contraception 4. BMI range of 18 to 33 kg/m² 5. Fluent English speakers 6. Non smoker or light smoker Exclusion Criteria: 1. Positive pre-study drug/alcohol...

Countries:United Kingdom
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Frequently asked questions about GSK424887

What is GSK424887 used for?

GSK424887 is an investigational small molecule being developed for depressive disorder and anxiety disorders. It is in Phase 1 clinical development and has been studied in healthy volunteers in the United Kingdom. The drug is not approved and remains in early-stage clinical testing.

Who makes GSK424887?

GSK424887 is being developed by GSK plc, a biopharmaceutical company traded on the New York Stock Exchange under the ticker GSK. The company has conducted Phase 1 clinical trials of the drug in the United Kingdom.

What phase is GSK424887 in?

GSK424887 is in Phase 1 clinical development. Two Phase 1 trials have been completed, both involving healthy volunteers. The drug is investigational and has not been approved for any use.

What clinical trials is GSK424887 in?

GSK424887 has been studied in two completed Phase 1 trials. NCT01059591 was a first-in-human study with 26 participants, and NCT01424384 examined emotional processing in healthy volunteers with 54 participants. Both trials were conducted in the United Kingdom and enrolled male participants aged 18 years and older.

Is GSK424887 the same as an investigational anxiolytic?

GSK424887 is the investigational drug referred to in the clinical trial NCT01424384, which is titled 'Emotional Processing in Healthy Volunteers in the Presence of an Investigational Anxiolytic.' The drug is being studied for its potential effects in depressive disorder and anxiety disorders.