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

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

Tracking Information

• First Submitted Date: December 1, 2011
• First Posted Date: May 21, 2012
• Last Update Posted Date: June 20, 2017
• Actual Study Start Date: November 22, 2011
• Actual Primary Completion Date: April 12, 2012 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Healthy Volunteer Positron Emission Tomography (PET) Brain Occupancy Study of a Phosphodiesterase 4 (PDE4) Inhibitor in Huntington's Disease
• 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)
• 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: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Huntington Disease

Intervention

• Drug: GSK356278
  Investigational Medicinal Product
• Drug: Rolipram
  Challenge Agent

Study Arms

Experimental: GSK356278

Investigational drug

Interventions:

• Drug: GSK356278
• Drug: Rolipram

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: May 17, 2012): 8
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: April 12, 2012
• Actual Primary Completion Date: April 12, 2012 (Final data collection date for primary outcome measure)

Eligibility 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)

Sex/Gender

• Sexes Eligible for Study: Male

• Ages: 22 Years to 55 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United Kingdom

Administrative Information

• NCT Number: NCT01602900
• Other Study ID Numbers: 116038
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided

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.

• Current Responsible Party: GlaxoSmithKline
• Original Responsible Party: Same as current
• Current Study Sponsor: GlaxoSmithKline
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: GSK Clinical Trials; GlaxoSmithKline

• PRS Account: GlaxoSmithKline
• Verification Date: June 2017