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GW856553

Phase 2

Healthy Subjects | Small molecule | Metabolic |GSK plc|Last Updated: Jun 6, 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
RandomizedDouble-BlindUNCONTROLLEDBiomarker
Total Trials1
Total Enrollment66
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00474864Study To Evaluate The Effects Of GW856553 On Endothelial Function/Vascular Compliance In Subjects With Dyslipidaemia.PHASE2 COMPLETED 66 — — Jul 1, 2007Apr 1, 2008Jun 6, 20123 United Kingdom
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Study Endpoints
Primary Endpoints
Forearm blood flow ratio measured at baseline and day 28.
at baseline and day 28.
Secondary Endpoints
Forearm blood flow ratio at (baseline and day28). Augmentation Index(baseline and day28). Pulse wave velocity (baseline and day28). pHSP-27 levels (baseline and day28).
baseline and day28
Safety and tolerability parameters (weekly)
weekly
Measurement of total and phosphorylated heat shock protein-27 (pHSP-27) levels in sorbitol induced whole blood cells of patients with dyslipidaemia
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
GW856553DRUG -
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Eligibility Criteria
Age Range18 Years — 75 Years
SexALL
Healthy VolunteersYes
Study Sites3

Inclusion Criteria: * Healthy adult male and females between 18 and 75 years of age, inclusive. * To be eligible, female subjects must have a negative pregnancy test (i.e. Urine or serum β-hCG (for females) and be of: * non-childbearing potential (i.e. physiologically incapable of becoming pregn...

Countries:United Kingdom
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