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Healthy SubjectsPhase 1NCT00468806

Study of Safety, Blood Levels and Brain Receptor Occupancy of GSK598809 Using PET Imaging in Health Males.

A Phase 1 study testing GSK598809, using [11C]-(+)-PHNO in people with Healthy Subjects, run by GlaxoSmithKline at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to look at how much of a new drug, GSK598809 binds to specific proteins in the brain and how much stays in the blood over a range of different doses. Read more about this study

Who is it for?
Ages 25 to 55 years, men onlyHealthy volunteers can take part
Conditions the study is for
Healthy Subjects
What is being tested?
GSK598809, using [11C]-(+)-PHNO
How many people
25 participants
Where
1 siteCanada
Study dates
Apr 2007to May 2008
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 25 to 55 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Healthy male subjects, defined as individuals who are free from clinically significant illness or disease as determined by their medical history (including family), physical examination, laboratory studies, and other tests.
  • Aged 25-55 years inclusive, at screening visit.
  • Body weight > 50 kg and body mass index (BMI) between 19.0 - 29.0 kg/m2 inclusive.
  • Capable of giving informed consent and can comply with the study requirements and timetable.
  • Self-administered Beck Depression Inventory II scale total score no greater than 9, and suicide question score of zero.
  • Able to read, comprehend and record information.
  • A signed and dated written informed consent is obtained from the subject.

Who cannot join

  • The physician responsible considers the subject unfit for the study based upon medical history, physical examination and psychiatric history and evaluation.
  • History of a drug or other allergy which in the opinion of the physician responsible contraindicates their participation in the study.
  • Participation in a clinical trial and has received a drug or a new chemical entity within 30 days or 5 half-lives, or twice the duration of the biological effect of any drug(whichever is longer) prior to the first dose of current study medication.
  • Exposure to more than four new chemical entities within 12 months prior to the first dosing day.
  • A screening ECG outside of ranges specified in the protocol
  • Pulse rate <55 or >100 bpm OR a systolic blood pressure >140 and <100 OR a diastolic blood pressure >90 and <60.
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  • History of long QT syndrome (personal or family) or other cardiac conduction disorder, or other clinically significant cardiac disease.
  • An electrolyte value outside the normal range at pre-study screening. Subjects who do not fall within the normal reference ranges may be included within the study if in the opinion of the Principal Investigator and Medical Monitor this will not compromise the subject.
  • Liver function tests (LFT) elevated above the reference range at pre-study screening that remain elevated with a repeat LFT.
  • Any other clinically significant laboratory abnormality.
  • Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John'sWort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to the first dose of study medication, unless in the opinion of the Investigator and sponsor the medication will not interfere with the study procedures or compromise subject safety.
  • History of regular alcohol consumption averaging >14 drinks/week for men. One drink is equivalent to(12 g alcohol) = 5 ounces (150 ml) of wine or 12 ounces (360 ml) of beer or 1.5 ounces (45 ml) of 80 proof distilled spirits) within 6 months of screening.
  • Smokes or has smoked in the last 6 months.
  • Donation of more than 450 ml blood within the 56 days before dosing.
  • An unwillingness of male subjects to abstain from sexual intercourse with pregnant or lactating women from the time of administration of study medication (GSK598809) until 90 days following administration of study medication or an unwillingness of the male subject to use a condom/spermicide in addition to having their female partner use another form of contraception if the woman could become pregnant from the time of administration of study medication until 90 days following administration of study medication.
  • Current or recent (within one year) gastrointestinal disease; a history of malabsorption, esophageal reflux, irritable bowel syndrome; frequent (more than once a week) occurrence of heartburn; or any surgical intervention (e.g., cholecysectomy) which would be expected to influence the absorption of drugs.
  • Any previous or current psychiatric diagnosis listed in DSMIV Axis I or II.
  • Any history of suicidal attempts, suicidal ideation or behaviour.
  • Chronic Hepatitis B and C, as evidenced by positive Hepatitis B surface antigen (HBsAg) or Hepatitis C antibody.
  • A positive test for HIV.
  • Past history of drug abuse (i.e. meeting DSM IV or ICD 10 criteria for substance dependence) or has tested positive for urine drugs of abuse at pre-study screening and/or prior to dosing.
  • Previous inclusion in a research and/or medical protocol involving nuclear medicine, PET or radiological investigations with significant radiation burden (a significant radiation burden being defined as ICRP category IIb or above: No more than 10 mSv in addition to natural background radiation, in the previous 3 years including the dose from this study).
  • Family history of cancer (one or more first-degree relative diagnosed before the age of 55).
  • History of or suffers from claustrophobia or feels that they will be unable to lie still on their back in the PET camera for a period of 2 hours.
  • History or presence of a neurological diagnosis (not limited to but including for example, stroke, traumatic brain injury, epilepsy, space occupying lesions, multiple sclerosis, Parkinson's disease, vascular dementia, transient ischemic attack, schizophrenia, major depression etc) that may influence the outcome or analysis of the scan results.
  • Presence of a cardiac pacemaker or other electronic device or ferromagnetic metal foreign bodies as assessed by a standard pre-MRI.

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • GSK Investigational Site

    Toronto, Ontario, M5T 1R8

Other trials in Canada

About this study

Official title: An Open Label Positron Emission Tomography Study in Healthy Male Subjects to Investigate Brain Dopamine D3 Occupancy Kinetics, Pharmacokinetics and Safety of Single Oral Doses of GSK598809, Using [11C]-(+)-PHNO as PET Ligand.

The purpose of this study is to look at how much of a new drug, GSK598809 binds to specific proteins in the brain and how much stays in the blood over a range of different doses.

Being tested
GSK598809, using [11C]-(+)-PHNO
Keywords
PET scan, Health Males

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GSK598809, using [11C]-(+)-PHNODrug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. %D3 RO at Tmax

    Measured: approx 1.5 hrs

  2. Percentage occupancy at Tmax

    Measured: approx 1.5 hrs

  3. Ttrough

    Measured: approx 24 hrs

  4. time course of GSK598809 plasma concentration following a single oral dose of GSK598809

    Measured: at predose,1,1.5,2,3,4,8,24 and 48 hrs.

Secondary outcomes (7)

  1. Prolactin/TSH levels

    Measured: at predose,1, 2, 4,8 & 24 hrs postdose

  2. Akathisia

    Measured: at baseline at 1, 4 hrs postdose

  3. EPQ, BIS-BAS:

    Measured: at screening

  4. POMS, CRT:

    Measured: at predose & 4 hrs postdose

  5. VAS:

    Measured: at predose, 1, 4 hrs postdose

  6. LSEQ

    Measured: at screening, baseline scan & 24 hrs

  7. neuroendocrine and behavioural measures following GSK598809 administration.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 May 2007 (estimated)
  2. Study startApr 2007
  3. Primary completionMay 2008
  4. Study completionMay 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
25 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00468806
Sponsor's protocol ID
DAN106589
Status last verified
Oct 2010
First submitted
1 May 2007
Last updated
28 Oct 2010
Results posted
No

Publications

  • Searle G, Beaver JD, Comley RA, Bani M, Tziortzi A, Slifstein M, Mugnaini M, Griffante C, Wilson AA, Merlo-Pich E, Houle S, Gunn R, Rabiner EA, Laruelle M. Imaging dopamine D3 receptors in the human brain with positron emission tomography, [11C]PHNO, and a selective D3 receptor antagonist. Biol Psychiatry. 2010 Aug 15;68(4):392-9. doi: 10.1016/j.biopsych.2010.04.038.

    PubMed 20599188

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing GSK598809, using [11C]-(+)-PHNO in people with Healthy Subjects, run by GlaxoSmithKline at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Oct 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

%D3 RO at Tmax (time frame: approx 1.5 hrs). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00468806, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2010.

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