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

NCT01602900 | Completed Phase 1

• 1 other identifier: 116038
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 2

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.

Conditions

Huntington Disease

Outcome Measures

Primary Outcomes (2)

• Positron Gamma-ray emmision & voxel counts

  Brain regions of interest and associated radionuclitide-activity

  60 minutes

• systemic plasma concentration

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

  24 hours

Secondary Outcomes (3)

• Blood pressure - mm/Hg

  24 hours

• ECG - 12-Lead & Telemetry

  24 & 72 hours

• Heart rate - bpm

  72 hours

Study Arms (1)

GSK356278

EXPERIMENTAL

Investigational drug

Drug: GSK356278; Drug: Rolipram

Interventions

GSK356278 DRUG

Investigational Medicinal Product

GSK356278

Rolipram DRUG

Challenge Agent

GSK356278

Eligibility Criteria

• Age: 22 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (2)

GSK Investigational Site

London, NW10 7EW, United Kingdom

Location

GSK Investigational Site

London, W12 ONN, United Kingdom

Location

Related Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
• Results for study 116038 can be found on the GSK Clinical Study Register.

MeSH Terms

Conditions

Huntington Disease

Interventions

5-(5-((2,4-dimethylthiazol-5-yl)methyl)-1,3,4-oxadiazol-2-yl)-1-ethyl-N-(tetrahydro-2H-pyran-4-yl)-1H-pyrazolo(3,4-b)pyridin-4-amine; Rolipram

Condition Hierarchy (Ancestors)

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; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2011
• First Posted: May 21, 2012
• Study Start: November 22, 2011
• Primary Completion: April 12, 2012
• Study Completion: April 12, 2012
• Last Updated: June 20, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will share

Locations

GB (2)