- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00937846
Brain Uptake of GSK1034702: a Positron Emission Tomography (PET) Scan Study
June 26, 2017 updated by: GlaxoSmithKline
An Open Label Positron Emission Tomography (PET) Study to Investigate Brain Penetration by [Carbonyl-11C] GSK1034702 in Healthy Subjects
GSK1034702 is being developed for improving cognitive impairment in diseases such as Alzheimer's disease and schizophrenia.
This study will be done in healthy men to investigate how much of the study drug gets into the brain.
This will be done using Positron Emission Tomography (PET).
Study Overview
Detailed Description
This is an open label, single dose, non-randomized PET study in healthy male subjects to ascertain if GSK1034702 is crossing the blood-brain barrier to enable it to elicit a central effect.
GSK1034702 has been shown in vitro to be a substrate for human Pgp, therefore the distribution of GSK1034702 into human brain could be adversely affected.
This use of PET in conjunction with radioactively labelled GSK1034702 will help ascertain the role Pgp plays in limiting brain penetration in the presence and absence of a pharmacological relevant oral non labelled dose of 5 mg.
Subjects will have an MRI scan to aid definition of brain anatomy, a baseline PET scan and a post-dose PET scan.
For each subject the study will consist of at least three visits; screening visit, scanning day and follow-up.
Study Type
Interventional
Enrollment (Actual)
4
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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London, United Kingdom, NW10 7EW
- GSK Investigational Site
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London, United Kingdom, W12 ONN
- GSK Investigational Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
35 years to 55 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
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 history of regular use of tobacco- or nicotine-containing products in the past 6 months.
- ECG abnormality (personal or family history).
- Psychiatric disorder.
- Asthma or a history of asthma.
- Medical illness.
- Worked as a welder, metal worker or machinist.
- Suffers from claustrophobia or would be unable to lie still in a PET or MRI scanner for 1-2 hours.
- Has a cardiac pacemaker or other electrical device or ferromagnetic metal foreign bodies.
- Neurological disorder
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: GSK1034702
Single oral 5 mg dose in liquid formulation
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Single oral 5 mg dose in liquid formulation
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Volume of distribution of [11C]GSK1034702 at tracer and pharmacological doses.
Time Frame: Scanning day
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Scanning day
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The kinetic rate constants at tracer and pharmacological doses.
Time Frame: Scanning day
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Scanning day
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GSK1034702 PK parameters: Cmax; tmax; AUC(0-t).
Time Frame: Scanning day
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Scanning day
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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.
Time Frame: 2 weeks
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2 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 15, 2009
Primary Completion (Actual)
August 28, 2009
Study Completion (Actual)
August 28, 2009
Study Registration Dates
First Submitted
June 25, 2009
First Submitted That Met QC Criteria
July 9, 2009
First Posted (Estimate)
July 13, 2009
Study Record Updates
Last Update Posted (Actual)
June 27, 2017
Last Update Submitted That Met QC Criteria
June 26, 2017
Last Verified
June 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 110771
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Study Data/Documents
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Clinical Study Report
Information identifier: 110771Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Individual Participant Data Set
Information identifier: 110771Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Statistical Analysis Plan
Information identifier: 110771Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Study Protocol
Information identifier: 110771Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Informed Consent Form
Information identifier: 110771Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Dataset Specification
Information identifier: 110771Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Annotated Case Report Form
Information identifier: 110771Information comments: For additional information about this study please refer to the GSK Clinical Study Register
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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