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14c}-GSK1349572

Phase 1

Undisclosed | Small molecule | Other |GSK plc|Trials Updated: Jun 5, 2009

14c}-GSK1349572 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Jan 2009

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment6

FDA Designations

No designations recorded

14c}-GSK1349572 clinical trials

14c}-GSK1349572 · 1 trial · 1 indication

Phase 1 1
NCT00828763GSK1349572 Mass Balance StudyHealthy Volunteer
COMPLETED6 Analytics
PHASE1COMPLETED
GSK1349572 Mass Balance Study
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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 to 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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Frequently asked questions about 14c}-GSK1349572

What is 14c}-GSK1349572?

14c}-GSK1349572 is an investigational small molecule developed by GSK plc. It has been studied in a Phase 1 mass balance trial in healthy male volunteers. The specific therapeutic indication for this compound has not been disclosed.

Who makes 14c}-GSK1349572?

14c}-GSK1349572 is being developed by GSK plc, which trades under the ticker GSK. GSK sponsored the Phase 1 mass balance study of the compound conducted in the United States.

What phase is 14c}-GSK1349572 in?

14c}-GSK1349572 is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are currently listed. The compound has not been approved by the FDA and remains investigational.

What clinical trials is 14c}-GSK1349572 in?

14c}-GSK1349572 has been evaluated in one completed Phase 1 trial, NCT00828763, titled the GSK1349572 Mass Balance Study. The trial enrolled 6 healthy male volunteers aged 30 years and older in the United States and was uncontrolled.

Is 14c}-GSK1349572 the same as GSK1349572?

Yes, 14c}-GSK1349572 is also known as GSK1349572. Both names refer to the same investigational small molecule developed by GSK plc. The trial registered under NCT00828763 uses the GSK1349572 name.