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

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ClinicalTrials.gov Identifier: NCT01602900
Recruitment Status : Completed
First Posted : May 21, 2012
Last Update Posted : June 20, 2017
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Huntington Disease Drug: GSK356278 Drug: Rolipram Phase 1

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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)
Actual Study Start Date : November 22, 2011
Actual Primary Completion Date : April 12, 2012
Actual Study Completion Date : April 12, 2012

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: GSK356278
Investigational drug
 Drug: GSK356278
Investigational Medicinal Product

Drug: Rolipram
Challenge Agent


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   22 Years to 55 Years   (Adult)
Sexes 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01602900


Locations
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United Kingdom
GSK Investigational Site
London, United Kingdom, NW10 7EW
GSK Investigational Site
London, United Kingdom, W12 ONN
Sponsors and Collaborators
GlaxoSmithKline
Investigators
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Study Director: GSK Clinical Trials GlaxoSmithKline
More Information
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Additional Information:
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.  This link exits the ClinicalTrials.gov site Results for study 116038 can be found on the GSK Clinical Study Register.  This link exits the ClinicalTrials.gov site

Study Data/Documents: Annotated Case Report Form  This link exits the ClinicalTrials.gov site
Identifier: 116038
For additional information about this study please refer to the GSK Clinical Study Register
Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: 116038
For additional information about this study please refer to the GSK Clinical Study Register
Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: 116038
For additional information about this study please refer to the GSK Clinical Study Register
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: 116038
For additional information about this study please refer to the GSK Clinical Study Register
Statistical Analysis Plan  This link exits the ClinicalTrials.gov site
Identifier: 116038
For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: 116038
For additional information about this study please refer to the GSK Clinical Study Register
Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: 116038
For additional information about this study please refer to the GSK Clinical Study Register

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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01602900     History of Changes
Other Study ID Numbers: 116038
First Posted: May 21, 2012    Key Record Dates
Last Update Posted: June 20, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Additional relevant MeSH terms:
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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
Neurocognitive Disorders
Mental Disorders
Rolipram
Antidepressive Agents
Psychotropic Drugs
Phosphodiesterase 4 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action