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14C GSK2251052

Phase 1

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

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
NCT01475695GSK2251052 Mass Balance in Healthy Adult SubjectsPHASE1 COMPLETED 6 — — Apr 21, 2011May 19, 2011Jun 28, 20171 Netherlands
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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 — 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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