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GSK729327

Phase 1

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedPLACEBO_CONTROLLED
Total Trials1
Total Enrollment79

FDA Designations

No designations recorded

Clinical trial landscape

GSK729327 · 1 trial · 1 indication

Phase 1 1
NCT00448890Evaluation of Single and Repeat Doses of GSK729327 in Healthy VolunteersSchizophrenia
COMPLETED79 Analytics
PHASE1COMPLETED
Evaluation of Single and Repeat Doses of GSK729327 in Healthy Volunteers
SchizophreniaUnlock trial analytics

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 to 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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Frequently asked questions about GSK729327

What is GSK729327 used for?

GSK729327 is an investigational small molecule being developed for the treatment of schizophrenia. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities. The drug is being studied in healthy volunteers to evaluate its safety and tolerability.

Who makes GSK729327?

GSK729327 is being developed by GSK plc, a global biopharmaceutical company listed on the stock exchange under the ticker GSK. The company is conducting clinical trials to evaluate the drug's safety and pharmacokinetics in healthy volunteers.

What phase is GSK729327 in?

GSK729327 is in Phase 1 clinical development. A Phase 1 trial has been completed, involving 79 healthy volunteers. The drug remains investigational and has not received regulatory approval for the treatment of schizophrenia or any other condition.

What clinical trials is GSK729327 in?

GSK729327 has one completed clinical trial, registered as NCT00448890, titled 'Evaluation of Single and Repeat Doses of GSK729327 in Healthy Volunteers.' This Phase 1 study enrolled 79 participants in Germany and the United Kingdom and was placebo-controlled.

Is GSK729327 FDA approved?

GSK729327 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development for schizophrenia. The completed Phase 1 trial was designed to evaluate safety and tolerability in healthy volunteers, and further clinical studies would be needed before any approval.