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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE December 1, 2011
First Posted Date  ICMJE May 21, 2012
Last Update Posted Date June 20, 2017
Actual Study Start Date  ICMJE November 22, 2011
Actual Primary Completion Date April 12, 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 17, 2012)
  • Positron Gamma-ray emmision & voxel counts [ Time Frame: 60 minutes ]
    Brain regions of interest and associated radionuclitide-activity
  • systemic plasma concentration [ Time Frame: 24 hours ]
    serial sampling: GSK356278 concentration expressed as mass per unit of volume
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 17, 2012)
  • Blood pressure - mm/Hg [ Time Frame: 24 hours ]
    Standard clinical pharmacology safety monitoring of vital signs
  • ECG - 12-Lead & Telemetry [ Time Frame: 24 & 72 hours ]
    Standard clinical pharmacology safety monitoring
  • Heart rate - bpm [ Time Frame: 72 hours ]
    Standard clinical pharmacology safety monitoring of vital signs
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Healthy Volunteer Positron Emission Tomography (PET) Brain Occupancy Study of a Phosphodiesterase 4 (PDE4) Inhibitor in Huntington's Disease
Official Title  ICMJE 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)
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Huntington Disease
Intervention  ICMJE
  • Drug: GSK356278
    Investigational Medicinal Product
  • Drug: Rolipram
    Challenge Agent
Study Arms  ICMJE Experimental: GSK356278
Investigational drug
Interventions:
  • Drug: GSK356278
  • Drug: Rolipram
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 17, 2012)
8
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 12, 2012
Actual Primary Completion Date April 12, 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 22 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01602900
Other Study ID Numbers  ICMJE 116038
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
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.
Current Responsible Party GlaxoSmithKline
Original Responsible Party Same as current
Current Study Sponsor  ICMJE GlaxoSmithKline
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: GSK Clinical Trials GlaxoSmithKline
PRS Account GlaxoSmithKline
Verification Date June 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP