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GW597901X

Phase 1

Asthma | Small molecule | Respiratory |GSK plc|Last Updated: May 18, 2009

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 Enrollment24
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00354042Effects Of Repeat Inhaled Doses Of GW597901X On Patient Safety And Lung Function In Asthmatic SubjectsPHASE1 COMPLETED 24Aug 1, 2004 -May 18, 2009 -
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Study Endpoints
Primary Endpoints
Safety Tolerability including blood test results, effects on the heart, pulse rate and blood pressure, and any side effects.
Secondary Endpoints
Effects on the lungs at 12 and 24 hours Effects on the heart, blood pressure and heart rate at 8 hours Effects on blood tests over 4 hours and 8 hours Reduction of rescue medication.
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER
PurposeTREATMENT
Interventions
NameTypeDescription
GW597901XDRUG -
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersNo

Inclusion criteria: * Subjects with mild to moderate stable asthma but no other lung problems. * Male subjects or female subjects who are not able to get pregnant (e.g. post-menopausal or surgically sterile). * Non-Smokers. * Subjects who show a measurable improvement in the function of their lungs...

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