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[14c}-GSK1349572

Phase 1

Healthy Volunteer | Small molecule | Other |GSK plc|Last Updated: Jun 5, 2009

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
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment6
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00828763GSK1349572 Mass Balance StudyPHASE1 COMPLETED 6 — — Feb 1, 2009Mar 1, 2009Jun 5, 20091 United States
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Study Endpoints
Primary Endpoints
• AUC (0-t), AUC (0-∞), Cmax, tmax, λz, tlag, and t1/2 of total drug-related material (radiocarbon) in blood and plasma following oral suspension [14C]-GSK1349572 dosing.
Up to 10 days
• AUC (0-t), AUC (0-∞), Cmax, tmax, λz, tlag, CL/F, Vz/F, and t1/2 of GSK1349572 in plasma following oral suspension [14C]-GSK1349572 dosing.
Up to 10 days
• Collection of samples for use in a separate study for characterization and quantification of GSK1349572-related metabolites in plasma, urine and fecal homogenates.
Up to 10 days
Percent recovery of total radiocarbon in urine and feces
Up to 10 days
Secondary Endpoints
• Safety and tolerability parameters, including adverse events (AEs), vital signs, ECGs, and clinical laboratory assessments.
Up to 14 days
Blood:Plasma ratio of total drug-related material (radioactivity)
Up to 10 days
Percent of total radiocarbon associated with red blood cells
Up to 10 days
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1EXPERIMENTAL\[14C\]-GSK1349572 administered as a single oral dose
Interventions
NameTypeDescription
[14c}-GSK1349572DRUGHIV-Integrase inhibitor labelled with a carbon 14 marker
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Eligibility Criteria
Age Range30 Years — 55 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy as determined by a responsible physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring. * Male subjects between 30 and 55 years of age. * Male subjects must agree to use one of the contraception ...

Countries:United States
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