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

Huntington Disease Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01602900
• Other study ID #: 116038
• Status: Completed
• Phase: Phase 1
• First received: December 1, 2011
• Last updated: June 19, 2017
• Start date: November 22, 2011
• Est. completion date: April 12, 2012

Study information

• Verified date: June 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: April 12, 2012
• Est. primary completion date: April 12, 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 22 Years to 55 Years

Eligibility

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)

Related Conditions & MeSH terms

• Huntington Disease

Intervention

Drug:
• GSK356278
Investigational Medicinal Product
• Rolipram
Challenge Agent

Locations

Country	Name	City	State
United Kingdom	GSK Investigational Site	London
United Kingdom	GSK Investigational Site	London

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Positron Gamma-ray emmision & voxel counts	Brain regions of interest and associated radionuclitide-activity	60 minutes
Primary	systemic plasma concentration	serial sampling: GSK356278 concentration expressed as mass per unit of volume	24 hours
Secondary	Blood pressure - mm/Hg	Standard clinical pharmacology safety monitoring of vital signs	24 hours
Secondary	ECG - 12-Lead & Telemetry	Standard clinical pharmacology safety monitoring	24 & 72 hours
Secondary	Heart rate - bpm	Standard clinical pharmacology safety monitoring of vital signs	72 hours

External 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.