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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00937846
First Posted: July 13, 2009
Last Update Posted: June 27, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
GlaxoSmithKline
  Purpose
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 Intervention Phase
Cognitive Disorders Drug: GSK1034702 Phase 1

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

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

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

Enrollment: 4
Actual Study Start Date: July 15, 2009
Study Completion Date: August 28, 2009
Primary Completion Date: August 28, 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: GSK1034702
Single oral 5 mg dose in liquid formulation
Drug: GSK1034702
Single oral 5 mg dose in liquid formulation

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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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
  Contacts and Locations
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
  More Information

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 Submitted: June 25, 2009
First Posted: July 13, 2009
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