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14C GSK2251052

Phase 1

Community-acquired Infection | Small molecule | Infectious Disease |GSK plc|Last Updated: Jun 28, 2017

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 GSK2251052 · 1 trial · 1 indication

Phase 1 1
NCT01475695GSK2251052 Mass Balance in Healthy Adult SubjectsCommunity-acquired Infection
COMPLETED6 Analytics
PHASE1COMPLETED
GSK2251052 Mass Balance in Healthy Adult Subjects
Community-acquired InfectionUnlock trial analytics

Study Endpoints

Primary Endpoints

Evaluate pharmacokinetic parameters for GSK2251052 and radiolabeled compound following intravenous dose
Up to 14 days
Area under the concentration-time curve from time zero (pre-dose) extrapolated to infinite time
Up to 14 days
Area under the concentration-time curve from time zero (pre-dose) to last time of quantifiable concentration within a subject across all treatments
Up to 14 days
Maximum observed concentration
Up to 14 days
Time of occurrence of maximum observed concentration
Up to 14 days
Terminal phase half-life
Up tp 14 days
Systemic clearance of parent drug
Up to 14 days
Volume of distribution
Up to 14 days
Percent recovery of total radiocarbon in urine and feces
Up to 14 days
Urine, fecal recovery and total recovery of radioactivity (as a percentage of total radioactive dose in each interval and cumulative)
Up to 14 days

Secondary Endpoints

Adverse events, vital signs, electrocardiogram and clinical laboratory assessments.
Up to 14 days
Collection of samples for characterization and quantification, or estimation, of GSK2251052-related metabolites in plasma, urine and fecal homogenates to be conducted under a separate protocol.
Up to 14 days
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeOTHER

Treatment Arms

ArmTypeDescription
Single cohortEXPERIMENTAL14C GSK2251052

Interventions

NameTypeDescription
14C GSK2251052DRUG1500 mg iv dose GSK2251052
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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 and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and ECG. A subject with a clinical abnormality or laboratory parameters outside the reference range for the populat...

Countries:Netherlands
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Frequently asked questions about 14C GSK2251052

What is 14C GSK2251052 used for?

14C GSK2251052 is an investigational small molecule being developed for community-acquired infection. It is a radiolabeled form of GSK2251052, used in a Phase 1 mass balance study to track the drug's absorption, distribution, metabolism, and excretion in the body. It is not yet approved and remains in clinical development.

Who makes 14C GSK2251052?

14C GSK2251052 is developed by GSK plc, traded on the New York Stock Exchange under the ticker GSK. The company is conducting clinical research on this investigational drug for the treatment of community-acquired infection.

What phase is 14C GSK2251052 in?

14C GSK2251052 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The single Phase 1 trial has been completed, and the drug is still in the early stages of clinical research.

What clinical trials is 14C GSK2251052 in?

14C GSK2251052 has one completed clinical trial, NCT01475695, titled "GSK2251052 Mass Balance in Healthy Adult Subjects." This Phase 1 study enrolled 6 healthy male volunteers in the Netherlands and was uncontrolled, meaning there was no comparator group.

Is 14C GSK2251052 the same as GSK2251052?

14C GSK2251052 is a radiolabeled version of GSK2251052, where the carbon-14 isotope is incorporated into the molecule. This labeling allows researchers to track the drug's fate in the body during mass balance studies. The therapeutic agent itself is GSK2251052.