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Trial record 6 of 6 for:    GSK239512

An Imaging Study to Investigate the Distribution of GSK239512 in the Brain.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00474513
Recruitment Status : Completed
First Posted : May 17, 2007
Last Update Posted : June 4, 2012
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Tracking Information
First Submitted Date  ICMJE May 15, 2007
First Posted Date  ICMJE May 17, 2007
Last Update Posted Date June 4, 2012
Study Start Date  ICMJE March 2007
Actual Primary Completion Date March 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 28, 2008)
Receptor occupancy in the brain after receiving a dose of GSK239512, measured using calculations from PET images at 4 hours and 24 hours post dose
Original Primary Outcome Measures  ICMJE
 (submitted: May 15, 2007)
Receptor occupancy in the brain after receiving a dose of GSK239512, measured using calculations from PET [ Time Frame: images at 4 hours and 24 hours post dose ]
Change History Complete list of historical versions of study NCT00474513 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 28, 2008)
Safety of drug and concentration of GSK239512 in the blood at various timepoints. Using vital signs and ECG, clinical laboratory assessments and PK sampling.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 15, 2007)
Safety of drug and concentration of GSK239512 in the blood at various timepoints. Using vital signs and ECG, clinical laboratory assessments and PK sampling. [ Time Frame: at various timepoints ]
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE An Imaging Study to Investigate the Distribution of GSK239512 in the Brain.
Official Title  ICMJE A PET Study Using [11C] GSK189254 to Establish the Dose, Plasma Concentration and Brain Receptor Occupancy Relationship of GSK239512, a Histamine H3 Antagonist, in Healthy Subjects
Brief Summary GSK239512 is being developed for the treatment of symptoms of cognitive impairment in many diseases. GSK239512 is a drug that binds to the Histamine 3 receptor (a protein) in the brain (receptor occupancy). This study will use the technique of positron emission tomography (PET) as an imaging tool to highlight areas of the brain that GSK239512 has penetrated, and subsequently bound to receptors, after receiving an oral dose of the drug. It will also look at the rate the drug dissociates from the receptors in the brain. Results from the study will provide information on doses of the drug to be given in further studies.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Mild Cognitive Impairment
  • Dementia
Intervention  ICMJE Drug: GSK239512
Study Arms Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 28, 2008)
5
Original Estimated Enrollment  ICMJE
 (submitted: May 15, 2007)
12
Actual Study Completion Date March 2008
Actual Primary Completion Date March 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male aged 35 to 49 inclusive at the screening visit.
  • Healthy, defined as individuals who are free from clinically significant illness or disease as determined by their medical history (including family history), physical examination, laboratory studies, and other tests as judged by the investigator.
  • Body weight ≥ 50 kg and BMI within the range of 19-29 kg/m2, inclusive.
  • Normal thyroid function tests as judged by the investigator.
  • Willingness of subjects to abstain from sexual intercourse with pregnant or lactating women; or willingness to use adequate contraception the time of the first dose of [11C]GSK189254 until completion of the study and for 84 days following the study.
  • Capable of giving informed consent and can comply with the study requirements and timetable.
  • The subject must be able to read, comprehend and record information.
  • A signed and dated written informed consent is obtained from the subject prior to taking part in the study.
  • The subject is able to understand and comply with protocol requirements, instructions and protocol-stated restrictions.
  • The subject must have a QTc<450msec (for males) or <480 msec for subjects with bundle branch block

Exclusion Criteria:

  • The subject has used or is using regular prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John's Wort) within fourteen days or five half lives (whichever was the longer) prior to the first dose of study medication, unless in the opinion of the Investigator and Sponsor the medication would not have interfered with the study procedures or compromised subject safety. Medications considered to be unlikely to interfere with the study are, thyroid replacement therapy, laxatives, occasional use of vitamin supplements, PRN paracetamol and NSAIDs, prophylactic aspirin.
  • The subject had a history of drug or alcohol abuse, or had a positive pre-study urine drug / alcohol screen. Abuse of alcohol is defined as an average weekly intake of greater than 21 units or an average daily intake of greater than three units for males. One unit is equivalent to a half-pint (220 mL) of beer or one (25 mL) measure of spirits or one glass (125 mL) of wine.
  • History of heavy use (>10 per day) of tobacco or nicotine-containing products within six months of the start of the study.
  • Heavy use of caffeine (>6 cups of caffeinated beverage per day).
  • The subject had a history or presence of drug or other significant allergy that, in the opinion of the responsible physician, contra-indicated their participation.
  • History or presence of neurological or significant psychiatric disease, such as depressive disorder (as defined by HAD depression score >8) or anxiety disorder (as defined by HAD anxiety score >8) See Appendix 7.
  • The subject has a history or presence of gastro-intestinal, hepatic or renal disease or other condition known to interfere with the absorption, distribution, metabolism or excretion of drugs.
  • The subject has donated blood (450 mL) within the last three months before the study.
  • The subject has participated in a clinical study with an investigational or a non- investigational drug or device during the previous three months or has participated in more than three studies in the previous year.
  • Previous inclusion in a research and/or medical protocol involving nuclear medicine, PET or radiological investigations with a significant radiation burden that, in combination with the PET scans, may result in the subject receiving more than 10mSv over the previous 3 years.
  • History or presence of neurological or psychiatric conditions (e.g., 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 or compromise subject safety.
  • Presence of a cardiac pacemaker or other electronic device or ferromagnetic metal foreign bodies in vulnerable positions as assessed by a standard pre-MRI questionnaire.
  • History of known or suspected seizures, unexplained significant loss of consciousness or history of significant head trauma with loss of consciousness. Subjects who had febrile seizures in childhood may be included if these have ceased by age 5 and they have had no other type of seizure in their medical history and have not been on anti-epileptic medications.
  • Allen's test result leading to concern about the patency of both the radial and ulnar arteries in the wrist that is being used for arterial cannulation.
  • Needle phobia or fear of arterial blood sampling.
  • A positive HIV-1/2, hepatitis B surface antigen or positive hepatitis C antibody result within 3 months of the start of the study.
  • Subjects with a QTc of >500 msec.
  • Subjects with a known history or presence of sleep disorders based on investigator review of medical history and symptoms
Sex/Gender
Sexes Eligible for Study: Male
Ages 35 Years to 49 Years   (Adult)
Accepts Healthy Volunteers Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00474513
Other Study ID Numbers  ICMJE H3B106026
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party GlaxoSmithKline
Study Sponsor  ICMJE GlaxoSmithKline
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: GSK Clinical Trials GlaxoSmithKline
PRS Account GlaxoSmithKline
Verification Date February 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP