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

Primary Purpose

Huntington Disease

Status

Completed

Phase

Phase 1

Locations

United Kingdom

Study Type

Interventional

Intervention

GSK356278

Rolipram

About this trial

This is an interventional treatment trial for Huntington Disease

Eligibility Criteria

22 Years - 55 Years (Adult)MaleAccepts Healthy Volunteers

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)

Sites / Locations

GSK Investigational Site
GSK Investigational Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

GSK356278

Arm Description

Investigational drug

Outcomes

Primary Outcome Measures

Positron Gamma-ray emmision & voxel counts

Brain regions of interest and associated radionuclitide-activity

systemic plasma concentration

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

Secondary Outcome Measures

Blood pressure - mm/Hg

Standard clinical pharmacology safety monitoring of vital signs

ECG - 12-Lead & Telemetry

Standard clinical pharmacology safety monitoring

Heart rate - bpm

Standard clinical pharmacology safety monitoring of vital signs

Full Information

NCT ID

NCT01602900

First Posted

December 1, 2011

Last Updated

June 19, 2017

Sponsor

GlaxoSmithKline

1. Study Identification

Unique Protocol Identification Number

NCT01602900

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)

Study Type

Interventional

2. Study Status

Record Verification Date

June 2017

Overall Recruitment Status

Completed

Study Start Date

November 22, 2011 (Actual)

Primary Completion Date

April 12, 2012 (Actual)

Study Completion Date

April 12, 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

GlaxoSmithKline

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Huntington Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

8 (Actual)

8. Arms, Groups, and Interventions

Arm Title

GSK356278

Arm Type

Experimental

Arm Description

Investigational drug

Intervention Type

Drug

Intervention Name(s)

GSK356278

Intervention Description

Investigational Medicinal Product

Intervention Type

Drug

Intervention Name(s)

Rolipram

Intervention Description

Challenge Agent

Primary Outcome Measure Information:

Title

Positron Gamma-ray emmision & voxel counts

Description

Brain regions of interest and associated radionuclitide-activity

Time Frame

60 minutes

Title

systemic plasma concentration

Description

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

Time Frame

24 hours

Secondary Outcome Measure Information:

Title

Blood pressure - mm/Hg

Description

Standard clinical pharmacology safety monitoring of vital signs

Time Frame

24 hours

Title

ECG - 12-Lead & Telemetry

Description

Standard clinical pharmacology safety monitoring

Time Frame

24 & 72 hours

Title

Heart rate - bpm

Description

Standard clinical pharmacology safety monitoring of vital signs

Time Frame

72 hours

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

22 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

GSK Clinical Trials

Organizational Affiliation

GlaxoSmithKline

Official's Role

Study Director

Facility Information:

Facility Name

GSK Investigational Site

City

London

ZIP/Postal Code

NW10 7EW

Country

United Kingdom

Facility Name

GSK Investigational Site

City

London

ZIP/Postal Code

W12 ONN

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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.

Links:

URL

https://www.clinicalstudydatarequest.com

Description

Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Available IPD and Supporting Information:

Available IPD/Information Type

Annotated Case Report Form

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

116038

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Available IPD/Information Type

Individual Participant Data Set

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

116038

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Available IPD/Information Type

Clinical Study Report

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

116038

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Available IPD/Information Type

Study Protocol

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

116038

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Available IPD/Information Type

Statistical Analysis Plan

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

116038

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Available IPD/Information Type

Dataset Specification

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

116038

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Available IPD/Information Type

Informed Consent Form

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

116038

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Learn more about this trial

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

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