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GSK729327

Phase 1

Schizophrenia | Small molecule | Psychiatry |GSK plc|Last Updated: Oct 15, 2010

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
RandomizedPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment79
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00448890Evaluation of Single and Repeat Doses of GSK729327 in Healthy VolunteersPHASE1 COMPLETED 79Nov 1, 2006Jan 1, 2009Oct 15, 20102 Germany, United Kingdom
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Study Endpoints
Primary Endpoints
Safety and tolerability endpoints of AEs; EEG; ECGs; neurological assessments; vital signs and clinical laboratory values.Part A PK parameters of Cmax,AUC,t1/2,Tmax,Ae(0-t).Part B PK parameters of Cmax,Tmax,t1/2,AUC and accumulation ratio.
throughout the study
Secondary Endpoints
Pharmacodynamic effects on Bond-Lader,Body Sway and EEG and the relationship of plasma levels of GSK729327 with pharmacodynamic parameters.Part B will also look atcognitive function,Polysomnography and LSEQ.
throughout the study
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Study Design & Arms
AllocationRANDOMIZED
MaskingSINGLE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
GSK729327EXPERIMENTALDose escalation from 1.0mg to 6 mg.
PlaceboPLACEBO_COMPARATOR -
Interventions
NameTypeDescription
GSK729327DRUGTablets
PlaceboDRUGGSK729327 Matching placebo - Tablets
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites2

Inclusion Criteria: * Healthy male subjects between the ages of 18 and 55 years inclusive. * Part B also includes healthy female subjects of non-child bearing potential. * A normal ECG, physical examination and laboratory screen. * Body weight \>50 kg and BMI within the range 18.5-29.9 kg/m2 inclus...

Countries:GermanyUnited Kingdom
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