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GSK376501

Phase 1

Type 2 Diabetes Mellitus | Small molecule | Metabolic |GSK plc|Last Updated: Jan 19, 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
RandomizedUNCONTROLLEDBiomarker
Total Trials3
Total Enrollment181
FDA Designations
No designations recorded
Clinical Trials (3)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00605449A Drug Interaction Study Between Simvastatin and GSK376501PHASE1 COMPLETED 39 — — Jan 1, 2008Mar 1, 2008Oct 19, 20101 United States
NCT00495014Study To Investigate The Safety And Metabolism Of GSK376501 In Overweight SubjectsPHASE1 COMPLETED 70 — — Jun 1, 2007Dec 1, 2007Oct 15, 20101 United States
NCT00404963A Study To Investigate The Safety And Metabolism Of GSK376501 In Overweight SubjectsPHASE1 COMPLETED 72 — — Oct 1, 2006May 1, 2007Jan 19, 20171 United States
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Study Endpoints
Primary Endpoints
drug plasma levels of GSK376501:
Day 7 Periods 1, 2 & 3
Adverse reactions and changes in laboratory values, vital signs, and/or ECGs following each dose
following each dose
Safety will be monitored by assessing adverse reactions,changes in laboratory values (hematology, clinical chemistry, urinalysis),changes in vital signs (oral body temperature,60 second respiratory rate, blood pressure and heart rate), and ECG changes.
throughout the study
Secondary Endpoints
drug plasma levels of GSK376501:
Day 7 all periods
adverse events, vital signs, con meds:
each visit, all periods
labs:
Days 4 & 8 all periods
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT
Interventions
NameTypeDescription
GSK376501DRUG -
PlaceboDRUG -
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
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. A subject with a clinical abnormality or laboratory parameters outside the reference range for the populati...

Countries:United States
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