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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-15

Study Completion Date

2009-08-28

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Cognitive Disorders

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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GSK1034702

Single oral 5 mg dose in liquid formulation

Group Type EXPERIMENTAL

GSK1034702

Intervention Type DRUG

Single oral 5 mg dose in liquid formulation

Interventions

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GSK1034702

Single oral 5 mg dose in liquid formulation

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

35 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

London, , United Kingdom

Site Status

GSK Investigational Site

London, , United Kingdom

Site Status

Countries

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United Kingdom

References

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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.

Reference Type DERIVED

PMID: 26116126 (View on PubMed)

Study Documents

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