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single dose

Phase 1

Alcoholism | Small molecule | Other |GSK plc|Last Updated: Jun 27, 2017

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment21
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01181908Alcohol Interaction StudyPHASE1 COMPLETED 21Nov 11, 2009Dec 30, 2009Jun 27, 20171 Netherlands
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Study Endpoints
Primary Endpoints
pharmacodynamic measures for various psychomotor/cognition function and subjective effects
pre and post study drug administration
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.
Interventions
NameTypeDescription
single doseDRUGSubjects will receive a single dose of GSK1144814 or placebo.
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Eligibility Criteria
Age Range18 Years — 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:Netherlands
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