Healthy Volunteer Positron Emission Tomography (PET) Brain Occupancy Study of a Phosphodiesterase 4 (PDE4) Inhibitor in Huntington's Disease

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

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-22

Study Completion Date

2012-04-12

Brief Summary

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This study will investigate if a new experimental drug to treat Huntington's Disease gets into the brain. If it does get into the brain the study will explore the relationship between the amount of drug in the brain and the amount of drug in the blood. The study will involve healthy male volunteers.

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Detailed Description

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This is an open label, non-randomized, adaptive design PET occupancy study in healthy adult males. The primary aim of this study is to describe the relationship between plasma concentrations and brain PDE4 occupancy of GSK356278 over time. Up to 24 healthy volunteers may be administered single doses of GSK356278 in order to obtain 12 evaluable complete data sets of occupancy estimates. This study will help to optimize the dose selection for future clinical studies with GSK356278.

Conditions

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Huntington Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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GSK356278

Investigational drug

Group Type EXPERIMENTAL

GSK356278

Intervention Type DRUG

Investigational Medicinal Product

Rolipram

Intervention Type DRUG

Challenge Agent

Interventions

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GSK356278

Investigational Medicinal Product

Intervention Type DRUG

Rolipram

Challenge Agent

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy male volunteer, aged 22-55 years.
* Normal blood pressure, laboratory values, and body mass index
* Willing to agree to study procedures \& contraception requirements
* Capable of giving written informed consent

Exclusion Criteria

* Any evidence of disease that would preclude participation in the clinical study (includes sexually transmitted diseases, exessive alcohol consumption, and substance abuse).
* Previously involved in another clinical trial within 3 months prior to scheduled administration of study drug
* Smoker
* Suffers from claustrophobia
* Any contraindications for MRI scanning (e.g. pacemaker, metal implants or fillings)

Minimum Eligible Age

22 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

Study Documents

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