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Brain Uptake of GSK1034702: a Positron Emission Tomography (PET) Scan Study

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ClinicalTrials.gov Identifier: NCT00937846
Recruitment Status : Completed
First Posted : July 13, 2009
Last Update Posted : June 27, 2017
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Cognitive Disorders Drug: GSK1034702 Phase 1

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  (Clinical Trial)
Actual Enrollment : 4 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: An Open Label Positron Emission Tomography (PET) Study to Investigate Brain Penetration by [Carbonyl-11C] GSK1034702 in Healthy Subjects
Actual Study Start Date : July 15, 2009
Actual Primary Completion Date : August 28, 2009
Actual Study Completion Date : August 28, 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: GSK1034702
Single oral 5 mg dose in liquid formulation
Drug: GSK1034702
Single oral 5 mg dose in liquid formulation



Primary Outcome Measures :
  1. Volume of distribution of [11C]GSK1034702 at tracer and pharmacological doses. [ Time Frame: Scanning day ]

Secondary Outcome Measures :
  1. The kinetic rate constants at tracer and pharmacological doses. [ Time Frame: Scanning day ]
  2. GSK1034702 PK parameters: Cmax; tmax; AUC(0-t). [ Time Frame: Scanning day ]
  3. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00937846


Locations
United Kingdom
GSK Investigational Site
London, United Kingdom, NW10 7EW
GSK Investigational Site
London, United Kingdom, W12 ONN
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline

Additional Information:
Study Data/Documents: Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: 110771
For additional information about this study please refer to the GSK Clinical Study Register
Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: 110771
For additional information about this study please refer to the GSK Clinical Study Register
Statistical Analysis Plan  This link exits the ClinicalTrials.gov site
Identifier: 110771
For additional information about this study please refer to the GSK Clinical Study Register
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: 110771
For additional information about this study please refer to the GSK Clinical Study Register
Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: 110771
For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: 110771
For additional information about this study please refer to the GSK Clinical Study Register
Annotated Case Report Form  This link exits the ClinicalTrials.gov site
Identifier: 110771
For additional information about this study please refer to the GSK Clinical Study Register

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00937846     History of Changes
Other Study ID Numbers: 110771
First Posted: July 13, 2009    Key Record Dates
Last Update Posted: June 27, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.

Keywords provided by GlaxoSmithKline:
Cognitive impairment
Schizophrenia
Alzheimer's Disease
PET

Additional relevant MeSH terms:
Cognition Disorders
Neurocognitive Disorders
Mental Disorders