Healthy Volunteer Positron Emission Tomography (PET) Brain Occupancy Study of a Phosphodiesterase 4 (PDE4) Inhibitor in Huntington's Disease
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ClinicalTrials.gov Identifier: NCT01602900 |
Recruitment Status :
Completed
First Posted : May 21, 2012
Last Update Posted : June 20, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Huntington Disease | Drug: GSK356278 Drug: Rolipram | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 8 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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) |
Actual Study Start Date : | November 22, 2011 |
Actual Primary Completion Date : | April 12, 2012 |
Actual Study Completion Date : | April 12, 2012 |

Arm | Intervention/treatment |
---|---|
Experimental: GSK356278
Investigational drug
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Drug: GSK356278
Investigational Medicinal Product Drug: Rolipram Challenge Agent |
- Positron Gamma-ray emmision & voxel counts [ Time Frame: 60 minutes ]Brain regions of interest and associated radionuclitide-activity
- systemic plasma concentration [ Time Frame: 24 hours ]serial sampling: GSK356278 concentration expressed as mass per unit of volume
- Blood pressure - mm/Hg [ Time Frame: 24 hours ]Standard clinical pharmacology safety monitoring of vital signs
- ECG - 12-Lead & Telemetry [ Time Frame: 24 & 72 hours ]Standard clinical pharmacology safety monitoring
- Heart rate - bpm [ Time Frame: 72 hours ]Standard clinical pharmacology safety monitoring of vital signs

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 22 Years to 55 Years (Adult) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
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)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01602900
United Kingdom | |
GSK Investigational Site | |
London, United Kingdom, NW10 7EW | |
GSK Investigational Site | |
London, United Kingdom, W12 ONN |
Study Director: | GSK Clinical Trials | GlaxoSmithKline |
Study Data/Documents: Annotated Case Report Form

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

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

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

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

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

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

For additional information about this study please refer to the GSK Clinical Study Register
Responsible Party: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT01602900 |
Other Study ID Numbers: |
116038 |
First Posted: | May 21, 2012 Key Record Dates |
Last Update Posted: | June 20, 2017 |
Last Verified: | June 2017 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
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. |
Huntington Disease 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 Cognition Disorders Neurocognitive Disorders Mental Disorders Rolipram Antidepressive Agents Psychotropic Drugs Phosphodiesterase 4 Inhibitors Phosphodiesterase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |