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

Phase 1

Completed

• Conditions: Huntington Disease
• Interventions: Drug: GSK356278; Drug: Rolipram

• Registration Number: NCT01602900
• Lead Sponsor: GlaxoSmithKline

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 Timeline

• Study Start: 2011-11-22
• Study First Submitted: 2011-12-01
• Primary Completion: 2012-04-12
• Study Completion: 2012-04-12
• Study First Submitted QC: 2012-05-17
• Study First Posted: 2012-05-21
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-19
• Last Update Posted: 2017-06-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 8

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
GSK356278	Rolipram	Investigational drug
GSK356278	GSK356278	Investigational drug

Primary Outcome Measures

Name	Time	Method
Positron Gamma-ray emmision & voxel counts	60 minutes	Brain regions of interest and associated radionuclitide-activity
systemic plasma concentration	24 hours	serial sampling: GSK356278 concentration expressed as mass per unit of volume

Secondary Outcome Measures

Name	Time	Method
Heart rate - bpm	72 hours	Standard clinical pharmacology safety monitoring of vital signs
ECG - 12-Lead & Telemetry	24 & 72 hours	Standard clinical pharmacology safety monitoring
Blood pressure - mm/Hg	24 hours	Standard clinical pharmacology safety monitoring of vital signs

Trial Locations

Locations (1)

GSK Investigational Site; 🇬🇧 London, United Kingdom