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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01602900
First received: December 1, 2011
Last updated: May 17, 2012
Last verified: May 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Huntington Disease
 Drug: GSK356278
Drug: Rolipram
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official 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)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Positron Gamma-ray emmision & voxel counts [ Time Frame: 60 minutes ] [ Designated as safety issue: No ]
    Brain regions of interest and associated radionuclitide-activity

  • systemic plasma concentration [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    serial sampling: GSK356278 concentration expressed as mass per unit of volume


Secondary Outcome Measures:
  • Blood pressure - mm/Hg [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
    Standard clinical pharmacology safety monitoring of vital signs

  • ECG - 12-Lead & Telemetry [ Time Frame: 24 & 72 hours ] [ Designated as safety issue: Yes ]
    Standard clinical pharmacology safety monitoring

  • Heart rate - bpm [ Time Frame: 72 hours ] [ Designated as safety issue: Yes ]
    Standard clinical pharmacology safety monitoring of vital signs


Enrollment: 8
Study Start Date: November 2011
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: GSK356278
Investigational drug
 Drug: GSK356278
Investigational Medicinal Product
Drug: Rolipram
Challenge Agent

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   22 Years to 55 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01602900

Locations
United Kingdom
GSK Investigational Site
London, United Kingdom, NW10 7NS
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01602900     History of Changes
Other Study ID Numbers: 116038
Study First Received: December 1, 2011
Last Updated: May 17, 2012
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Huntington Disease
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Dementia
Chorea
Dyskinesias
Movement Disorders
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Genetic Diseases, Inborn
Cognition Disorders
 Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Rolipram
Phosphodiesterase 4 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013