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GSK1034702

Phase 1

Cognitive Disorders | Small molecule | Other |GSK plc|Last Updated: Jul 21, 2017

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials2
Total Enrollment34

FDA Designations

No designations recorded

Clinical trial landscape

GSK1034702 · 2 trials · 1 indication

Phase 1 2
NCT00937846Brain Uptake of GSK1034702: a Positron Emission Tomography (PET) Scan StudyCognitive Disorders
COMPLETED4 Analytics
NCT00743405Safety, Tolerability and Pharmacokinetics of GSK1034702 in Healthy SubjectsCognitive Disorders
COMPLETED30 Analytics
PHASE1COMPLETED
Brain Uptake of GSK1034702: a Positron Emission Tomography (PET) Scan Study
Cognitive DisordersUnlock trial analytics
PHASE1COMPLETED
Safety, Tolerability and Pharmacokinetics of GSK1034702 in Healthy Subjects
Cognitive DisordersUnlock trial analytics

Study Endpoints

Primary Endpoints

Volume of distribution of [11C]GSK1034702 at tracer and pharmacological doses.
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•Safety and tolerability determined by adverse events; ECG; Holter; blood pressure, heart rate, respiration rate; clinical laboratory evaluations, pupil size & temperature.•Blood concentrations of GSK1034702.
20 weeks

Secondary Endpoints

The kinetic rate constants at tracer and pharmacological doses.
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GSK1034702 PK parameters: Cmax; tmax; AUC(0-t).
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Safety and tolerability endpoints consisting of: AEs; 12-lead ECG; 12 lead digital Holter and lead II telemetry; vital signs; clinical laboratory evaluations.
2 weeks
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeSUPPORTIVE_CARE

Treatment Arms

ArmTypeDescription
GSK1034702EXPERIMENTALSingle oral 5 mg dose in liquid formulation
Cohort 1OTHERSubjects will be receive GSK1034702 0.5 milligram (mg) following the dose escalation plan
Cohort 2OTHERSubjects will be receive GSK1034702 5 mg following the dose escalation plan

Interventions

NameTypeDescription
GSK1034702DRUGSingle oral 5 mg dose in liquid formulation
PlaceboDRUGTo match GSK1034702
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Eligibility Criteria

Age Range35 Years to 55 Years
SexMALE
Healthy VolunteersYes
Study Sites2

Inclusion Criteria: * Generally healthy. * Male between 35 and 55 years of age. * Willing to use appropriate contraception method. * Weight more than 50 kg. * BMI within the range 19 - 29 kg/m2. * Adequate blood supply to the hand. Exclusion Criteria: * Abuse of drugs or alcohol. * Smoker or hist...

Countries:United Kingdom
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Competitive Landscape -Cognitive Disorders 9 trials

Frequently asked questions about GSK1034702

What is GSK1034702 used for?

GSK1034702 is an investigational small molecule being developed for cognitive disorders. It is a Phase 1 candidate that has been studied in healthy volunteers to evaluate its safety, tolerability, and pharmacokinetics, as well as its brain uptake using PET imaging. It is not yet approved and remains in clinical development.

Who makes GSK1034702?

GSK1034702 is being developed by GSK plc, a global biopharma company listed on the London Stock Exchange under the ticker GSK. The company has sponsored two Phase 1 clinical trials for this candidate, both of which have been completed.

What phase is GSK1034702 in?

GSK1034702 is in Phase 1 clinical development. Two Phase 1 trials have been completed, with a total of 34 participants enrolled. The drug is investigational and has not been approved by regulatory authorities for any use.

What clinical trials is GSK1034702 in?

GSK1034702 has been studied in two completed Phase 1 trials. NCT00743405 evaluated safety, tolerability, and pharmacokinetics in 30 healthy subjects in the United Kingdom. NCT00937846 assessed brain uptake via PET scanning in 4 healthy male volunteers aged 35 years and older.

Is GSK1034702 the same as any other drug?

No alternative names for GSK1034702 have been identified. The drug is referred to solely by its development code GSK1034702 in the clinical trial records and is not known to be marketed under any other name.