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SB-568859

Phase 1

Atherosclerosis | Small molecule | Cardiovascular |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
RandomizedUNCONTROLLED
Total Trials1
Total Enrollment28
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00470145Comparison Of Two Tablet Formulations Of SB-568859PHASE1 COMPLETED 28Apr 1, 2007Jul 1, 2007Jun 4, 20121 United States
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Study Endpoints
Primary Endpoints
Comparison of the amount of SB-568859 found in the blood over a period of 6 days after a single dose of each of the two types of tablets
6 days
Secondary Endpoints
Assessment of the safety and tolerability of SB-568859 after a single dose of each of the two types of tablets based on blood and urine tests, vital signs, electrocardiograms and reporting of side effects over a period of 6 days after each dose.
6 days
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Study Design & Arms
AllocationRANDOMIZED
MaskingSINGLE
ModelCROSSOVER
PurposeTREATMENT
Interventions
NameTypeDescription
SB-568859DRUG -
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Eligibility Criteria
Age Range18 Years — 50 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy men and sterile women between 18 and 50 years old * Body weight greater than 50 pounds and a body mass index between 19 and 31 * Normal electrocardiogram Exclusion criteria: * No history of asthma or severe allergic reactions * No history of or current drug use * No ...

Countries:United States
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