Status:
COMPLETED
[11C]Carfentanil PET Study of GSK1521498
Lead Sponsor:
GlaxoSmithKline
Conditions:
Obesity
Eligibility:
MALE
25-65 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to determine whether GSK1521498 attaches to sites in the brain called mu-opioid receptors that are involved in the liking reactions to palatable high fat and high sugar fo...
Detailed Description
This imaging study will be an open-label, non-randomised PET receptor occupancy study in healthy male volunteers. The degree and time course of μ-opioid receptor occupancy (RO) following single oral d...
Eligibility Criteria
Inclusion
- Healthy male subjects aged between 25 and 65 years old inclusive.
- Body weight ≥ 50 kg and BMI within the range 18.5.0 - 30.0 kg/m2 (inclusive).
- Normal ECG.
- The subject is able to read, comprehend and record information.
- A signed and dated written informed consent is obtained from the subject.
- Compliance with birth control methods as described in the study protocol.
Exclusion
- A subject will not be eligible for inclusion in this study if any of the following criteria apply:
- The subject has a positive pre-study drug/alcohol screen.
- History of hepatitis B and /or C
- A positive result for an HIV test.
- Abnormal thyroid function
- Positive evaluation for depression.
- History of heavy alcohol use as described in the study protocol.
- The subject has participated in a clinical trial and has received an investigational product within: 90 days.
- Participation in other drug studies within a calendar year.
- Use of prohibited medications as described in the study protocol.
- History of sensitivity to any of the study medications.
- Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56 day period
- Unwillingness or inability to follow the procedures outlined in the protocol.
- Past or present use of tobacco products.
- Consumption of red wine, seville oranges, grapefruit or grapefruit juice from 7 days prior to the first dose of study medication.
- Previous radiation dosages in excess of levels acceptable to take part in this study.
- History of claustrophobia or history of neurological conditions.
- Presence of a cardiac pacemaker.
- Works as a welder, metal worker or machinist
Key Trial Info
Start Date :
June 15 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 7 2009
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT00976066
Start Date
June 15 2009
End Date
December 7 2009
Last Update
June 20 2017
Active Locations (1)
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1
GSK Investigational Site
London, United Kingdom, NW10 7EW