Back to results

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

Primary Purpose

Cognitive Disorders

Status

Completed

Phase

Phase 1

Locations

United Kingdom

Study Type

Interventional

Intervention

GSK1034702

About this trial

This is an interventional supportive care trial for Cognitive Disorders focused on measuring Cognitive impairment, Schizophrenia, Alzheimer's Disease, PET

Eligibility Criteria

35 Years - 55 Years (Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

GSK Investigational Site
GSK Investigational Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

GSK1034702

Arm Description

Single oral 5 mg dose in liquid formulation

Outcomes

Primary Outcome Measures

Volume of distribution of [11C]GSK1034702 at tracer and pharmacological doses.

Secondary Outcome Measures

The kinetic rate constants at tracer and pharmacological doses.

GSK1034702 PK parameters: Cmax; tmax; AUC(0-t).

Safety and tolerability endpoints consisting of: AEs; 12-lead ECG; 12 lead digital Holter and lead II telemetry; vital signs; clinical laboratory evaluations.

Full Information

NCT ID

NCT00937846

First Posted

June 25, 2009

Last Updated

June 26, 2017

Sponsor

GlaxoSmithKline

1. Study Identification

Unique Protocol Identification Number

NCT00937846

Brief Title

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

Official Title

An Open Label Positron Emission Tomography (PET) Study to Investigate Brain Penetration by [Carbonyl-11C] GSK1034702 in Healthy Subjects

Study Type

Interventional

2. Study Status

Record Verification Date

June 2017

Overall Recruitment Status

Completed

Study Start Date

July 15, 2009 (Actual)

Primary Completion Date

August 28, 2009 (Actual)

Study Completion Date

August 28, 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

GlaxoSmithKline

4. Oversight

5. Study Description

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).

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cognitive Disorders

Keywords

Cognitive impairment, Schizophrenia, Alzheimer's Disease, PET

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

4 (Actual)

8. Arms, Groups, and Interventions

Arm Title

GSK1034702

Arm Type

Experimental

Arm Description

Single oral 5 mg dose in liquid formulation

Intervention Type

Drug

Intervention Name(s)

GSK1034702

Intervention Description

Single oral 5 mg dose in liquid formulation

Primary Outcome Measure Information:

Title

Volume of distribution of [11C]GSK1034702 at tracer and pharmacological doses.

Time Frame

Scanning day

Secondary Outcome Measure Information:

Title

The kinetic rate constants at tracer and pharmacological doses.

Time Frame

Scanning day

Title

GSK1034702 PK parameters: Cmax; tmax; AUC(0-t).

Time Frame

Scanning day

Title

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

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

35 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

GSK Clinical Trials

Organizational Affiliation

GlaxoSmithKline

Official's Role

Study Director

Facility Information:

Facility Name

GSK Investigational Site

City

London

ZIP/Postal Code

NW10 7EW

Country

United Kingdom

Facility Name

GSK Investigational Site

City

London

ZIP/Postal Code

W12 ONN

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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.

Citations:

PubMed Identifier

26116126

Citation

Ridler K, Cunningham V, Huiban M, Martarello L, Pampols-Maso S, Passchier J, Gunn RN, Searle G, Abi-Dargham A, Slifstein M, Watson J, Laruelle M, Rabiner EA. An evaluation of the brain distribution of [(11)C]GSK1034702, a muscarinic-1 (M 1) positive allosteric modulator in the living human brain using positron emission tomography. EJNMMI Res. 2014 Dec;4(1):66. doi: 10.1186/s13550-014-0066-y. Epub 2014 Dec 5.

Results Reference

derived

Links:

URL

https://www.clinicalstudydatarequest.com

Description

Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Available IPD and Supporting Information:

Available IPD/Information Type

Clinical Study Report

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

110771

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Available IPD/Information Type

Individual Participant Data Set

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

110771

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Available IPD/Information Type

Statistical Analysis Plan

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

110771

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Available IPD/Information Type

Study Protocol

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

110771

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Available IPD/Information Type

Informed Consent Form

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

110771

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Available IPD/Information Type

Dataset Specification

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

110771

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Available IPD/Information Type

Annotated Case Report Form

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

110771

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Learn more about this trial

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

We'll reach out to this number within 24 hrs