A PET Study in Healthy Volunteers

NCT01424449 | Completed Phase 1

• 1 other identifier: 113549
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Depressive Disorder

Outcome Measures

Primary Outcomes (1)

• volume of distribution

  Regional volume of distribution (VT) in sub-cortical, brainstem and cerebellar regions of interest at each PET scan.

  one year

Study Arms (1)

no treatment

EXPERIMENTAL

Aripiprazole is a D2/D3 antagonist registered in the UK for use in the treatment of schizophrenia. It allows the highest clinically acceptable blockade of central D2/D3 receptors and will allow us to examine the amount of displaceable binding in the brain - a proposed reference tissue for \[11C\]PHNO.

Radiation: [11C]PHNO; Drug: Aripiprazole

Interventions

[11C]PHNO RADIATION

examine the effects of \[11C\]PHNO mass carry-over and displaceable binding

no treatment

Aripiprazole DRUG

A 4th scan will follow a 15mg dose of aripiprazole (a D2/D3 compound which allows the highest clinically acceptable blockade of central D2/D3 receptors)

no treatment

Eligibility Criteria

• Age: 22 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

London, London, W12 ONN, United Kingdom

Location

MeSH Terms

Conditions

Depressive Disorder

Interventions

naxagolide; Aripiprazole

Condition Hierarchy (Ancestors)

Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2011
• First Posted: August 29, 2011
• Study Start: January 1, 2010
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: December 17, 2012

Record last verified: 2012-03

Locations

GB (1)