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14c}-GSK1349572

Phase 1

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

Clinical trial landscape

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 used for?

14c-GSK1349572 is an investigational small molecule being studied in healthy volunteers. It is currently in Phase 1 clinical development, with a completed mass balance study. The drug is not approved and remains under investigation for its potential use.

Who makes 14c-GSK1349572?

14c-GSK1349572 is being developed by GSK plc, a pharmaceutical company traded on the stock exchange under the ticker GSK. The company is conducting clinical trials to evaluate this investigational small molecule.

What phase is 14c-GSK1349572 in?

14c-GSK1349572 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. A Phase 1 mass balance study has been completed as part of its early-stage evaluation.

What clinical trials is 14c-GSK1349572 in?

14c-GSK1349572 has one completed clinical trial, registered as NCT00828763. This Phase 1 study, titled 'GSK1349572 Mass Balance Study,' enrolled 6 healthy male volunteers in the United States. The trial was uncontrolled and not randomized or double-blinded.

Is 14c-GSK1349572 the same as GSK1349572?

Yes, 14c-GSK1349572 is a radiolabeled form of GSK1349572, used in a mass balance study to track the drug's absorption, distribution, metabolism, and excretion in the body. The clinical trial NCT00828763 specifically investigated this labeled version.