Status:
COMPLETED
A PET Study in Healthy Volunteers
Lead Sponsor:
GlaxoSmithKline
Conditions:
Depressive Disorder
Eligibility:
MALE
22-55 years
Phase:
PHASE1
Brief Summary
This will be an open label, non-randomised \[11C\]PHNO PET study using healthy male volunteers. Each volunteer will undergo 4 \[11C\]PHNO PET scans to allow for further characterisation of this radiol...
Detailed Description
A test-retest (TRT) investigation of \[11C\]PHNO in human is required to further characterise \[11C\]PHNO. \[11C\] PHNO possesses very high affinity for the D3 receptor, and therefore most clinical st...
Eligibility Criteria
Inclusion
- Healthy as determined by a responsible physician
- Male subjects between 25 and 55 years of age.
- Male subjects must agree to use one of the contraception methods listed
- Capable of giving written informed consent
Exclusion
- The subject has a positive pre-study drug/alcohol screen
- The subjects is using or has used regular prescription or non-prescription drugs
- Current or recent (within one year) gastrointestinal disease
- A screening ECG with a QTc value of \>450msec and/or a PR interval outside the range 120 to 200msec or an ECG that is not suitable for QT measurements
- Pulse rate \<50 or \>100 bpm OR a systolic blood pressure \>140 or \<100 OR a diastolic blood pressure \>90 or \<60.
- History of long QT syndrome (personal or family) or other cardiac conduction disorder, or other clinically significant cardiac disease.
- Any previous or current psychiatric diagnosis listed in DSM-IV Axis I or II
- Any history of suicidal attempts, suicidal ideation or behaviour as assessed by appropriately trained study personnel.
- History of alcohol dependence
- The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).
- Exposure to more than four new chemical entities within 12 months prior to the first dosing day.
- History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or GSK Medical Monitor, contraindicates their participation.
- Where participation in the study would result in donation of blood or blood products in excess of 550 mL within a 56 day period.
- Previous inclusion in a research and/or medical protocol involving nuclear medicine, PET or radiological investigations with significant radiation burden
- Family history of cancer
- History of claustrophobia or subjects feeling that he will be unable to lie still on his back in the PET camera for a period of \~2 hours at a time.
- History or presence of a neurological diagnosis
- Presence of a cardiac pacemaker or other electronic device or ferromagnetic metal foreign bodies as assessed by a standard pre-MRI questionnaire.
- Unwillingness or inability to follow the procedures outlined in the protocol. -
Key Trial Info
Start Date :
January 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2010
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT01424449
Start Date
January 1 2010
End Date
July 1 2010
Last Update
December 17 2012
Active Locations (1)
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1
GSK Investigational Site
London, London, United Kingdom, W12 ONN