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Radiolabelled GSK189075

Phase 1

Type 2 Diabetes Mellitus | Small molecule | Metabolic |GSK plc|Last Updated: Jun 4, 2012

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 Enrollment8
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00501683A Single Dose Of GSK189075 Taken By Mouth Containing Small Amounts Of Radioactivity Studied In Healthy Male VolunteersPHASE1 COMPLETED 8 — — Nov 1, 2006 -Jun 4, 20121 United States
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Study Endpoints
Primary Endpoints
Laboratory tests to determine the amount of radiolabelled drug that is found in blood, urine, and feces. Blood samples at Days 1-5.
at Days 1-5.
Urine & Fecal collection at Day -1 & days 1-5.
at Day -1 & days 1-5.
Secondary Endpoints
Adverse events (AEs), vital signs, ECGs and clinical laboratory assessments at each day for up to 10 days
at each day for up to 10 days
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Interventions
NameTypeDescription
Radiolabelled GSK189075DRUG -
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Eligibility Criteria
Age Range30 Years — 55 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Are a healthy, non-smoking male. * Are 30 to 55 years old, inclusive. * Have a Body Mass Index (BMI) between 19-30 kg/m2, inclusive; and a body weight \>110 lbs. * Have a history of regular bowel movements (at least 4 times per week). * Are willing and able to provide written ...

Countries:United States
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