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Safety, Tolerability and Pharmacokinetics of GSK1034702 in Healthy Subjects

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ClinicalTrials.gov Identifier: NCT00743405
Recruitment Status : Completed
First Posted : August 28, 2008
Last Update Posted : July 21, 2017
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Tracking Information
First Submitted Date  ICMJE August 27, 2008
First Posted Date  ICMJE August 28, 2008
Last Update Posted Date July 21, 2017
Actual Study Start Date  ICMJE May 2, 2008
Actual Primary Completion Date December 15, 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 21, 2009)
•Safety and tolerability determined by adverse events; ECG; Holter; blood pressure, heart rate, respiration rate; clinical laboratory evaluations, pupil size & temperature.•Blood concentrations of GSK1034702. [ Time Frame: 20 weeks ]
Original Primary Outcome Measures  ICMJE
 (submitted: August 27, 2008)
•Safety and tolerability determined by adverse events; ECG; Holter; blood pressure, heart rate, respiration rate; clinical laboratory evaluations, pupil size & temperature.•Blood concentrations of GSK1034702.
Change History Complete list of historical versions of study NCT00743405 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 29, 2009)
  • Assessment of the Bond-Lader Visual Analogue Scale. [ Time Frame: 20 weeks ]
  • Assessment of exploratory PD markers: neuroendocrine markers, e.g. growth hormone. [ Time Frame: 20 weeks ]
  • Relationship between GSK1034702 plasma concentrations and safety/tolerability or exploratory PD endpoints with selected pharmacodynamic and safety parameters. [ Time Frame: 20 weeks ]
Original Secondary Outcome Measures  ICMJE
 (submitted: August 27, 2008)
  • Assessment of the Bond-Lader Visual Analogue Scale.
  • Assessment of exploratory PD markers: neuroendocrine markers, e.g. growth hormone.
  • Relationship between GSK1034702 plasma concentrations and safety/tolerability or exploratory PD endpoints with selected pharmacodynamic and safety parameters.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety, Tolerability and Pharmacokinetics of GSK1034702 in Healthy Subjects
Official Title  ICMJE Single-blind, Randomised, Placebo Controlled Study to Evaluate the Safety, Tolerability and Pharmacokinetics of GSK1034702 in Healthy Subjects
Brief Summary This is a First Time in Human Study to assess the safety, tolerability and pharmacokinetics of single doses of GSK1034702 in healthy subjects. It will be a single-blind, randomized, placebo-controlled, single oral dose, dose-rising, cross-over study in healthy male and female (of non-child bearing potential) subjects. Subjects will be randomized into cohorts of 10 subjects and cohorts will be recruited until the pre-defined safety or PK stopping limits are reached. Each subject will receive placebo and up to 4 doses of GSK1034702 in a randomized sequence on 5 separate study occasions.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Cognitive Disorders
Intervention  ICMJE
  • Drug: GSK1034702
    Oral or liquid
  • Drug: Placebo
    To match GSK1034702
Study Arms  ICMJE
  • Cohort 1
    Subjects will be receive GSK1034702 0.5 milligram (mg) following the dose escalation plan
    Interventions:
    • Drug: GSK1034702
    • Drug: Placebo
  • Cohort 2
    Subjects will be receive GSK1034702 5 mg following the dose escalation plan
    Interventions:
    • Drug: GSK1034702
    • Drug: Placebo
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: August 27, 2008)
30
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 15, 2008
Actual Primary Completion Date December 15, 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy as determined by a responsible physician, based on a medical evaluation including own and familial medical history, physical examination, laboratory tests and cardiac monitoring.
  • Male or female between 18 and 55 years of age.
  • A female subject is eligible to participate if she is of non-childbearing potential
  • Body weight > 50 kg and BMI within the range 19 - 29.9 kg/m2 (inclusive).
  • Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
  • Capable of reading, comprehending and writing English at a sufficient level to complete study-related materials.
  • Demonstrates no evidence of mental impairment.
  • No co-morbid Psychiatric Disorders as defined using the Mini International Neuropsychiatric Interview

Exclusion Criteria:

  • A positive pre-study drug/alcohol screen.
  • A positive pre-study Hepatitis B , Hepatitis C or HIV.
  • History of regular alcohol consumption.
  • 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.
  • Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements .
  • History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy.
  • Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56 day period.
  • Pregnant females, females planning pregnancy or lactating females.
  • Unwillingness or inability to follow the procedures outlined in the protocol.
  • History of sensitivity to heparin or heparin-induced thrombocytopenia.
  • Subjects with a current or a history of psychiatric illness.
  • Subjects with any history of suicidal attempts or behavior.
  • Urinary cotinine levels indicative of smoking or history or regular use of tobacco- or nicotine-containing products.
  • Consumption of red wine, seville oranges, grapefruit or grapefruit juice (and pummelos, exotic citrus fruits, grapefruit hybrids or fruit juices) from 7 days prior to the first dose of study medication.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00743405
Other Study ID Numbers  ICMJE 110623
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE 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 July 2017

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