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Drug

Phase 1

Mental Disorders | Small molecule | Psychiatry |GSK plc|Last Updated: Jun 14, 2017

Target and mechanism

ModalitySmall molecule

Also known as Drug 1

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment9

FDA Designations

No designations recorded

Clinical trial landscape

Drug · 1 trial · 1 indication

Phase 1 1
NCT01371799A Study to Examine the Pharmacodynamic Effects of GSK1034702 on Neurophysiological Biomarkers of Cognition in Nicotine Abstained Otherwise Healthy SmokersMental Disorders
COMPLETED9 Analytics
PHASE1COMPLETED
A Study to Examine the Pharmacodynamic Effects of GSK1034702 on Neurophysiological Biomarkers of Cognition in Nicotine Abstained Otherwise Healthy Smokers
Mental DisordersUnlock trial analytics

Study Endpoints

Primary Endpoints

Measures will include changes in cognition measures of specific biomarkers
12 months

To investigate the effects of GSK1034702 on the mismatch negativity neurophysiologic marker of cognition.

Secondary Endpoints

Measures will include changes in the neurophysiologic markers of cognition
12 Months
Measures of changes in cognition biomarkers vs. the stduy drug
12 months
Measures of cogstate tests of attention in tests mentioned To investigate the effects of GSK1034702 on Cogstate neuropsychologic tests of attention, working memory, learning and executive function
12 months
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Study drug at 4mgEXPERIMENTALGSK1034702 at 4mg
Study drug at 8mgEXPERIMENTALGSK1034702 at 8mg
PlaceboPLACEBO_COMPARATORPlacebo

Interventions

NameTypeDescription
DrugDRUGPlacebo
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Eligibility Criteria

Age Range18 Years to 55 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria A subject will be eligible for inclusion in this study only if all of the following criteria apply: * Otherwise healthy smokers as determined by a responsible physician, based on a medical evaluation including own and familial medical history, physical examination, psychiatric hi...

Countries:United Kingdom
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Competitive Landscape -Mental Health Disorders 10 trials (matched to "Mental Disorders")

No competing companies are currently tracked in active development for Mental Health Disorders.
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Frequently asked questions about Drug

What is Drug used for?

Drug is an investigational small molecule being studied for use in mental disorders. It is in Phase 1 clinical development, with a completed trial that examined its pharmacodynamic effects on neurophysiological biomarkers of cognition in nicotine abstained otherwise healthy smokers.

Who makes Drug?

Drug is being developed by GSK plc, a pharmaceutical company traded on the stock exchange under the ticker GSK. The company is conducting clinical research on this investigational small molecule for mental disorders.

What phase is Drug in?

Drug is in Phase 1 clinical development. A Phase 1 trial has been completed, and the drug remains investigational. It is not approved by regulatory authorities and is still undergoing clinical research.

What clinical trials is Drug in?

Drug has one completed clinical trial, identified as NCT01371799. This Phase 1 study examined the pharmacodynamic effects of Drug on neurophysiological biomarkers of cognition in nicotine abstained otherwise healthy smokers. The trial enrolled 9 male participants in the United Kingdom.

Is Drug the same as Drug 1?

Yes, Drug is also known as Drug 1. Both names refer to the same investigational small molecule being developed by GSK plc for mental disorders.

Was the Drug trial randomized and controlled?

The completed Phase 1 trial for Drug was randomized, double-blind, and placebo-controlled. It enrolled 9 healthy male volunteers aged 18 years and older in the United Kingdom, and the study has been completed.