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single dose

Phase 1

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

single dose development status

Highest phase Phase 1
Registered trials 5 across 4 sponsors since Aug 2007

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials2
Total Enrollment43

FDA Designations

No designations recorded

single dose clinical trials

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.

What does GSK561679 target?

GSK561679 targets the corticotropin-releasing factor receptor, which is involved in the body's stress response. By modulating this receptor, the drug may influence emotional processing and potentially affect symptoms of depression and anxiety. This mechanism was studied in a Phase 1 trial measuring brain activation during emotional tasks.

Who makes GSK561679?

GSK561679 is being developed by GSK plc, a global biopharmaceutical company listed on the stock exchange under the ticker symbol GSK. The company conducted a Phase 1 clinical trial of the drug in the United States to evaluate its effects on brain activity in healthy female volunteers.

What phase is GSK561679 in?

GSK561679 is in Phase 1 clinical development. A Phase 1 trial with the identifier NCT00513565 was completed, involving 22 healthy female volunteers in the United States. The drug is investigational and has not received FDA approval for any indication.

What clinical trials is GSK561679 in?

GSK561679 was studied in one completed Phase 1 clinical trial, NCT00513565, titled "A Study To Investigate Effects Of GSK561679 On Brain Activation During Emotional Processing In Healthy Volunteers." The trial enrolled 22 healthy female participants aged 18 years and older in the United States.

Is GSK561679 the same as other drugs?

GSK561679 is a distinct investigational compound and is not known to be the same as any other marketed drug. It is being developed specifically for potential use in depressive and anxiety disorders, and its development is separate from other GSK products.