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GSK971086

Phase 1

Healthy Subjects | Small molecule | Other |GSK plc|Last Updated: Mar 19, 2012

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-BlindUNCONTROLLEDBiomarker
Total Trials1
Total Enrollment126
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00540553Study to Test Safety, Tolerability and Blood Levels of GSK971086 After 1 Dose & 7 Days of Dosing in Healthy Adult MalesPHASE1 COMPLETED 126Aug 1, 2007Apr 1, 2008Mar 19, 20121 United States
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Study Endpoints
Primary Endpoints
Adverse events:
all visits
hematology, clinical chemistry, urinalysis:
Part A Days -2,2,3,14,28 & Part B Days -2,2,5,8,14,21,35
vital signs & 12-lead ECGs:
Part A Days -2-3,7,28 & Part B Days -2-9,14,35
Secondary Endpoints
GSK 971086 Plasma blood level:
art A Days 1,2,3,7,14,21,28 & Part B Days 1-9,14,21,28,35
PBone & muscle biomarkers:
Part A Days 1,2,7,14,21,28 & Part B Days 1,3,8,14,21,28,35
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelSINGLE_GROUP
PurposeTREATMENT
Interventions
NameTypeDescription
placeboDRUG -
GSK971086DRUG -
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Eligibility Criteria
Age Range18 Years — 50 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Males between 18 and 50 years of age (inclusive), at the time of signing the informed consent form. * Healthy, as determined by the Investigator, based on medical evaluations performed during the Screening Period including medical history, physical examination, clinical labora...

Countries:United States
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