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

Cognitive Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00937846
• Other study ID #: 110771
• Status: Completed
• Phase: Phase 1
• First received: June 25, 2009
• Last updated: June 26, 2017
• Start date: July 15, 2009
• Est. completion date: August 28, 2009

Study information

• Verified date: June 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4
• Est. completion date: August 28, 2009
• Est. primary completion date: August 28, 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 35 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Cognition Disorders
• Cognitive Disorders

Intervention

Drug:
• GSK1034702
Single oral 5 mg dose in liquid formulation

Locations

Country	Name	City	State
United Kingdom	GSK Investigational Site	London
United Kingdom	GSK Investigational Site	London

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Volume of distribution of [11C]GSK1034702 at tracer and pharmacological doses.		Scanning day
Secondary	The kinetic rate constants at tracer and pharmacological doses.		Scanning day
Secondary	GSK1034702 PK parameters: Cmax; tmax; AUC(0-t).		Scanning day
Secondary	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

External Links

•   Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
•   Results for study 110771 can be found on the GSK Clinical Study Register.