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NCT Number: NCT01602900

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

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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Key information

Conditions

Huntington Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Chorea Cognition Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dementia Dyskinesias Genetic Diseases, Inborn Heredodegenerative Disorders, Nervous System Mental Disorders Movement Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases

Age range

22 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

GSK Investigational Site, London, United Kingdom

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

GSK356278

Drug

Investigational Medicinal Product

Rolipram

Drug

Challenge Agent

Primary outcomes

  1. Positron Gamma-ray emmision & voxel counts

    Time frame: 60 minutes

    Brain regions of interest and associated radionuclitide-activity

  2. systemic plasma concentration

    Time frame: 24 hours

    serial sampling: GSK356278 concentration expressed as mass per unit of volume

Secondary outcomes

  1. Blood pressure - mm/Hg

    Time frame: 24 hours

    Standard clinical pharmacology safety monitoring of vital signs

  2. ECG - 12-Lead & Telemetry

    Time frame: 24 & 72 hours

    Standard clinical pharmacology safety monitoring

  3. Heart rate - bpm

    Time frame: 72 hours

    Standard clinical pharmacology safety monitoring of vital signs

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

An Open Label Positron Emission Tomography Study in Healthy Male Subjects to Investigate Brain PDE4 Engagement, Pharmacokinetics and Safety of Single Oral Doses of GSK356278, Using 11C-(R)-Rolipram as a PET Ligand(s)

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
May 21, 2012
Registry last updated
Jun 20, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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