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GSK561679 or

Phase 1

Healthy Subjects | Small molecule | Other |GSK plc|Last Updated: Oct 19, 2010

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
UNCONTROLLED
Total Trials1
Total Enrollment12
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00539136A Study to Examine the Absorption of GSK561679 in Healthy Male VolunteersPHASE1 COMPLETED 12 — — Oct 1, 2007Mar 1, 2008Oct 19, 20101 United States
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Study Endpoints
Primary Endpoints
Pharmacokinetic scope of GSK561679 after application in a solution and in a new tablet formula per treatment phase Complete gastric emptying of radioactive marker after application of GSK561679 Complete tablet breakdown per treatment phase
Secondary Endpoints
AUC(0-24h), AUC(0-t), AUC(0-∞) of GSK561679 after administration of GSK561679 in a solution (fasted) and in a new "optimized" tablet formulation (fasted and fed).
lambda_Z (and t1/2), tlag, Ka, the time to absorb the 25, 50 and 90% of the total absorbed dose
•Other pharmacokinetic parameters of GSK561679 per treatment phase •Safety and tolerability parameters, including adverse events, clinical laboratory,vital signs and 12-lead ECGs measured at each dosing period and throughout the study
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeDIAGNOSTIC
Interventions
NameTypeDescription
GSK561679 tablet or solutionDRUG -
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Eligibility Criteria
Age Range18 Years — 55 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy males aged 18-55 years, inclusive. * Healthy subjects, defined as individuals who are free from clinically significant illness or disease (including peptic ulcer disease and psychiatric illness) as determined by their medical and psychiatric history (including family),...

Countries:United States
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