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GSK580416

Phase 1

Respiratory Tract Infection | Small molecule | Infectious Disease |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
RandomizedUNCONTROLLEDBiomarker
Total Trials1
Total Enrollment48
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00427141A Three-Part Study Of GSK580416 In Healthy SubjectsPHASE1 COMPLETED 48Oct 1, 2006 -Jun 4, 20121 Australia
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Study Endpoints
Primary Endpoints
Safety assessments (adverse event, ECG and vital sign) will be performed during the study. Blood samples to determine drug levels in the body will be collected during the study.
during the study
Secondary Endpoints
Blood samples to determine drug levels in the body will be collected during the study.
during the study
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Study Design & Arms
AllocationRANDOMIZED
MaskingSINGLE
ModelCROSSOVER
PurposeTREATMENT
Interventions
NameTypeDescription
GSK580416DRUG -
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion criteria: * Healthy as determined by a physician * Healthy male or female of non-child bearing potential between 18 and 55 years of age (inclusive) * Body weight \> = 50 kg and BMI between 19 and 30 kg/m2 (inclusive) Exclusion criteria: * Positive HIV antibody, Hepatitis B surface antig...

Countries:Australia
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