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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01602900
Other study ID # 116038
Secondary ID
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
Health authority
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)

Study Design


Related Conditions & MeSH terms


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
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