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GW642444H

Phase 1

Pulmonary Disease, Chronic Obstructive | Small molecule | Other |GSK plc|Last Updated: Aug 7, 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-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment20
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00463697A Study To Investigate The Effect Of Inhaling A Single Dose Of GW642444M In Asthmatic PatientsPHASE1 COMPLETED 20 — — Apr 2, 2007Aug 4, 2007Aug 7, 20173 United Kingdom
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Study Endpoints
Primary Endpoints
General safety and tolerability of the new formulation of GW642444 as measured by ECG, blood pressure, pulse rate and blood and urine tests. Serial measurements are made over 24 hours on 5 separate occasions (separated by 1 - 2 weeks).
Serial measurements are made over 24 hours on 5 separate occasions (separated by 1 - 2 weeks).
Secondary Endpoints
Airways relaxation assessed by lung function tests. Effect of study medicine on the body and amount of medicine in the body measured by potassium, glucose and medicine in blood samples. Measurements made over 24 hours on 5 occasions (1-2 weeks apart).
Measurements made over 24 hours on 5 occasions (1-2 weeks apart).
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
GW642444M 25mcgEXPERIMENTALSubject will inhale single dose of GW642444M 25 mcg via a DISKUS device in morning.
GW642444M 100mcgEXPERIMENTALSubject will inhale single dose of GW642444M 100 mcg via a DISKUS device in morning.
GW642444M 400mcgEXPERIMENTALSubject will inhale single dose of GW642444M 400 mcg via a DISKUS device in morning.
GW642444H 100mcgEXPERIMENTALSubject will inhale single dose of GW642444H 100 mcg via a DISKUS device in morning.
placeboPLACEBO_COMPARATORSubject will inhale single dose of Placebo via a DISKUS device in morning.
Interventions
NameTypeDescription
GW642444H (100mcg)DRUGH salt
placeboDRUGplacebo
GW642444M (25, 100 & 400 mcg)DRUGM salt
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Eligibility Criteria
Age Range18 Years — 70 Years
SexALL
Healthy VolunteersNo
Study Sites3

Inclusion criteria: * male or female (of non-childbearing potential) between 18 - 70 years * History of stable mild to moderate asthma * non - smokers * currently taking daily doses of inhaled fluticasone propionate 200 - 500 mcg (or equivalent) * body weight \>50 kg with BMI 19-29.9 kg/m2 * normal...

Countries:United Kingdom
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