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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT01602900 |
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Date of registration:
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01/12/2011 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Healthy Volunteer Positron Emission Tomography (PET) Brain Occupancy Study of a Phosphodiesterase 4 (PDE4) Inhibitor in Huntington's Disease
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Scientific title:
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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) |
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Date of first enrolment:
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November 22, 2011 |
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Target sample size:
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8 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01602900 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 1
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Countries of recruitment
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United Kingdom
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Contacts
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Name:
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GSK Clinical Trials |
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Address:
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Telephone:
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Email:
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Affiliation:
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GlaxoSmithKline |
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Key inclusion & exclusion criteria
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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)
Age minimum:
22 Years
Age maximum:
55 Years
Gender:
Male
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Health Condition(s) or Problem(s) studied
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Huntington Disease
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Intervention(s)
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Drug: GSK356278
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Drug: Rolipram
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Primary Outcome(s)
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Positron Gamma-ray emmision & voxel counts
[Time Frame: 60 minutes]
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systemic plasma concentration
[Time Frame: 24 hours]
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Secondary Outcome(s)
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Heart rate - bpm
[Time Frame: 72 hours]
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ECG - 12-Lead & Telemetry
[Time Frame: 24 & 72 hours]
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Blood pressure - mm/Hg
[Time Frame: 24 hours]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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