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OpenTrials
Completed

NCT Number: NCT00743405

Safety, Tolerability and Pharmacokinetics of GSK1034702 in Healthy Subjects

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.

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

GSK Investigational Site

London, NW10 7NS, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

GSK1034702

Drug

Oral or liquid

Placebo

Drug

To match GSK1034702

Primary outcomes

  1. •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

Secondary outcomes

  1. Assessment of the Bond-Lader Visual Analogue Scale.

    Time frame: 20 weeks

  2. Assessment of exploratory PD markers: neuroendocrine markers, e.g. growth hormone.

    Time frame: 20 weeks

  3. Relationship between GSK1034702 plasma concentrations and safety/tolerability or exploratory PD endpoints with selected pharmacodynamic and safety parameters.

    Time frame: 20 weeks

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

Single-blind, Randomised, Placebo Controlled Study to Evaluate the Safety, Tolerability and Pharmacokinetics of GSK1034702 in Healthy Subjects

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Aug 28, 2008
Registry last updated
Jul 21, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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