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single dose

Phase 1

Alcoholism | Unknown | Psychiatry |GSK plc|Last Updated: Jul 21, 2017

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment21

FDA Designations

No designations recorded

Clinical trial landscape

single dose · 2 trials · 2 indications

Phase 1 2
NCT01181908Alcohol Interaction StudyAlcoholism
COMPLETED21 Analytics
NCT00513565A Study To Investigate Effects Of GSK561679 On Brain Activation During Emotional Processing In Healthy VolunteersDepressive Disorder and Anxiety Disorders
COMPLETED22 Analytics
PHASE1COMPLETED
Alcohol Interaction Study
AlcoholismUnlock trial analytics
PHASE1COMPLETED
A Study To Investigate Effects Of GSK561679 On Brain Activation During Emotional Processing In Healthy Volunteers
Depressive Disorder and Anxiety DisordersUnlock trial analytics

Study Endpoints

Primary Endpoints

pharmacodynamic measures for various psychomotor/cognition function and subjective effects
pre and post study drug administration
Differences in fMRI brain activation (BOLD) response in specific brain regions
conducted the duration of the study

Secondary Endpoints

alcohol level
during and post alcohol administration
blood level of GSK1144814
pre and post study drug administration
safety and tolerability as measured by adverse events, vital signs, clinical laboratory measurements and validated clinical assessment scales
throughout the study pre- and post dose
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER
PurposeOTHER

Treatment Arms

ArmTypeDescription
GSK1144814EXPERIMENTALSubjects will receive either GSK1144814 or placebo at each treatment arm.
placeboPLACEBO_COMPARATORSubjects will receive either GSK1144814 or placebo at each treatment arm.
placebo armPLACEBO_COMPARATORThere are single dose treatment arms of GSK561679, lorazepam as well as placebo.
GSK561679 armEXPERIMENTALThere are single dose treatment arms of GSK561679, lorazepam as well as placebo.
lorazepam armACTIVE_COMPARATORThere are single dose treatment arms of GSK561679, lorazepam as well as placebo.

Interventions

NameTypeDescription
single doseDRUGSubjects will receive a single dose of GSK1144814 or placebo.
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy male and female * Body weight 50 kg or higher and BMI within the range 19 - 29.9 kg/m2 * Willing to use appropriate contraception methods Exclusion Criteria: * Positive HIV, Hepatitis B surface antigen or Hepatitis C antibody result * Any serious medical disorder or ...

Countries:NetherlandsUnited States
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Frequently asked questions about single dose

What is GSK561679 used for?

GSK561679 is an investigational drug being studied for use in depressive disorder and anxiety disorders. It was evaluated in a Phase 1 clinical trial in healthy volunteers to investigate its effects on brain activation during emotional processing. The drug is still in clinical development and has not been approved by regulatory authorities.

Who makes GSK561679?

GSK561679 is being developed by GSK plc, a pharmaceutical company listed on the stock exchange under the ticker GSK. The company conducted Phase 1 clinical trials to study the drug's effects in healthy volunteers and its potential use in psychiatric conditions such as depressive disorder and anxiety disorders.

What phase is GSK561679 in?

GSK561679 is in Phase 1 clinical development. It has completed Phase 1 trials, including a study on brain activation during emotional processing in healthy volunteers. As an investigational drug, it is not yet approved and remains in early-stage clinical testing.

What clinical trials is GSK561679 in?

GSK561679 has been studied in Phase 1 clinical trials, including NCT00513565, which examined its effects on brain activation during emotional processing in healthy volunteers with depressive disorder and anxiety disorders. This trial was completed in the United States with 22 female participants.

Is GSK561679 the same as Paxil CR or Secotex?

GSK561679 is not the same as Paxil CR or Secotex. Paxil CR (paroxetine) and Secotex (tamsulosin) are separate drugs studied in bioequivalence trials listed alongside GSK561679 in the same developer's portfolio. GSK561679 is a distinct investigational compound with its own clinical development program.