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GW685698X & GW642444M

Phase 1

Asthma | Small molecule | Respiratory |GSK plc|Last Updated: Aug 4, 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
RandomizedDouble-BlindUNCONTROLLEDBiomarker
Total Trials1
Total Enrollment16
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00538057Comparing Two Respiratory Drugs When Used In Combination And Separately From A Novel Inhaler Device In Healthy SubjectsPHASE1 COMPLETED 16Oct 2, 2007Dec 1, 2007Aug 4, 20171 Australia
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Study Endpoints
Primary Endpoints
Maximum heart rate
over 4 hours after dosing.
Blood pressure
changes over 12 hours.
Electrocardiogram
changes over 12 hours.
Change in peak expiry flow rate
changes over 24 hours.
Change in serum cortisol concentration
changes over 24 hours.
Secondary Endpoints
Change in plasma drug concentration (AUC, Cmax, t1/2, tmax)
over 48 hours after dosing.
Change in blood potassium levels
within 4 hours of drug dosing.
Mean heart rate
over 4 hours after dosing
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
arm 1EXPERIMENTALstudy drug
Interventions
NameTypeDescription
GW685698X & GW642444MDRUGstudy drug
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Eligibility Criteria
Age Range18 Years — 60 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion criteria: * Healthy adults aged between 18 and 60 years. * Male subjects or female subjects of non child bearing potential. * Body weight at least 50 kg and BMI within the range of 19-31 kg/m2 inclusive. * No significant abnormality from ECG at screening. * FEV1 at least 90% predicted and...

Countries:Australia
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