Last updated: 11/03/2018 15:17:06
A PET study in Healthy Volunteers
GSK study ID
113549
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A positron emission tomography study in healthy male subjects to examine the test-retest reliability of the D2/3 agonist radiotracer [11C]PHNO
Trial description: 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 radioligand and examine the effects of [11C]PHNO mass carry-over and displaceable binding in the brain. This study aims to obtain data from 6 evaluable subjects.
Primary purpose:
Other
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Not applicable
Primary outcomes:
volume of distribution
Timeframe: one year
Secondary outcomes:
Not applicable
Interventions:
Radiation: [11C]PHNO
Drug: Aripiprazole
Enrollment:
7
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Depressive Disorder
Product
Not applicable
Collaborators
Not applicable
Study date(s)
January 2010 to July 2010
Type
Interventional
Phase
1
Participation criteria
Sex
Male
Age
22 - 55 years
Accepts healthy volunteers
Yes
- 1. Healthy as determined by a responsible physician
- 2. Male subjects between 25 and 55 years of age.
- 1. The subject has a positive pre-study drug/alcohol screen
- 2. The subjects is using or has used regular prescription or non-prescription drugs
Inclusion and exclusion criteria
Inclusion criteria:
- 1. Healthy as determined by a responsible physician 2. Male subjects between 25 and 55 years of age. 3. Male subjects must agree to use one of the contraception methods listed 4. Capable of giving written informed consent
Exclusion criteria:
- 1. The subject has a positive pre-study drug/alcohol screen 2. The subjects is using or has used regular prescription or non-prescription drugs 3. Current or recent (within one year) gastrointestinal disease 4. 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 5. Pulse rate <50 or >100 bpm OR a systolic blood pressure >140 or <100 OR a diastolic blood pressure >90 or <60. 6. History of long QT syndrome (personal or family) or other cardiac conduction disorder, or other clinically significant cardiac disease. 7. Any previous or current psychiatric diagnosis listed in DSM-IV Axis I or II 8. Any history of suicidal attempts, suicidal ideation or behaviour as assessed by appropriately trained study personnel. 9. History of alcohol dependence 10. 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). 11. Exposure to more than four new chemical entities within 12 months prior to the first dosing day. 12. 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. 13. Where participation in the study would result in donation of blood or blood products in excess of 550 mL within a 56 day period. 14. Previous inclusion in a research and/or medical protocol involving nuclear medicine, PET or radiological investigations with significant radiation burden 15. Family history of cancer 16. 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. 17. History or presence of a neurological diagnosis 18. Presence of a cardiac pacemaker or other electronic device or ferromagnetic metal foreign bodies as assessed by a standard pre-MRI questionnaire. 19. Unwillingness or inability to follow the procedures outlined in the protocol. -
Trial location(s)
Location
GSK Investigational Site
London, London, United Kingdom, W12 ONN
Status
Study Complete
Study documents
No study documents available.
Results overview
Study Results yet to be posted
Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2010-01-07
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
Additional information
Not applicable
Participate in clinical trial
Access to clinical trial data by researchers
Visit website