Last updated: 11/07/2018 10:04:48
Healthy Volunteer Positron Emission Tomography (PET) Brain Occupancy study of a Phosphodiesterase 4 (PDE4) inhibitor in Huntington's Disease
Clinicaltrials.gov ID
EudraCT ID
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
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)
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:
Positron Gamma-ray emmision & voxel counts
Timeframe: 60 minutes
systemic plasma concentration
Timeframe: 24 hours
Secondary outcomes:
Blood pressure - mm/Hg
Timeframe: 24 hours
ECG - 12-Lead & Telemetry
Timeframe: 24 & 72 hours
Heart rate - bpm
Timeframe: 72 hours
Interventions:
Enrollment:
8
Primary completion date:
Not applicable
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Huntington Disease
Product
GSK356278
Collaborators
Not applicable
Study date(s)
November 2011 to April 2012
Type
Interventional
Phase
1
Participation criteria
Sex
Male
Age
22 - 55 years
Accepts healthy volunteers
Yes
- Healthy male volunteer, aged 22-55 years.
- Normal blood pressure, laboratory values, and body mass index
- 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
Inclusion and exclusion 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) -
Trial location(s)
Location
GSK Investigational Site
London, London, United Kingdom, W12 ONN
Status
Terminated/Withdrawn
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Study complete
Actual primary completion date
Not applicable
Actual study completion date
2012-12-04
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
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Additional information
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