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GSK704838

Phase 1

Pulmonary Disease, Chronic Obstructive | Small molecule | Other |GSK plc|Last Updated: Oct 31, 2016

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 Enrollment20
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00539825Effect of GSK704838 In Healthy VolunteersPHASE1 COMPLETED 20 — — Sep 1, 2007Feb 1, 2008Oct 31, 20161 United Kingdom
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Study Endpoints
Primary Endpoints
adverse events, vital signs,12-lead ECG, Holter and ECG monitoring,lung function and clinical lab tests. These will be taken pre-dose and at multiple time points up to 48h at each treatment period.
Secondary Endpoints
- Plasma and urine concentrations of GSK704838 and derived pharmacokinetic parameters over 48h post-dose. - Serial sGaw, Raw and FEV1 measurements over 24h post-dose.
Serial specific airway conductance (sGaw), Forced Expiratory Volume in 1 second (FEV1) and Forced Vital Capacity measurements (FVC) over 24 hours post-dose of GSK704838 and tiotropium bromide.
Serial sGaw measurements over 48 hours for the last period in each cohort dose of GSK704838 and tiotropium bromide.
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER
PurposeTREATMENT
Interventions
NameTypeDescription
GSK704838DRUG -
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Eligibility Criteria
Age Range18 Years — 55 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy male subject * Aged between 18-55 years inclusive. * Non-smokers * Normal spirometry * A signed and dated written informed consent is obtained from the subject. * The subject is capable of giving informed consent, which includes compliance with the requirements and res...

Countries:United Kingdom
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