Safety, Tolerability and Pharmacokinetics of GSK1034702 in Healthy Subjects
- Registration Number
- NCT00743405
- Lead Sponsor
- GlaxoSmithKline
- 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 available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Cohort 1 GSK1034702 Subjects will be receive GSK1034702 0.5 milligram (mg) following the dose escalation plan Cohort 1 Placebo Subjects will be receive GSK1034702 0.5 milligram (mg) following the dose escalation plan Cohort 2 GSK1034702 Subjects will be receive GSK1034702 5 mg following the dose escalation plan Cohort 2 Placebo Subjects will be receive GSK1034702 5 mg following the dose escalation plan
- Primary Outcome Measures
Name Time Method •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. 20 weeks
- Secondary Outcome Measures
Name Time Method Assessment of the Bond-Lader Visual Analogue Scale. 20 weeks Assessment of exploratory PD markers: neuroendocrine markers, e.g. growth hormone. 20 weeks Relationship between GSK1034702 plasma concentrations and safety/tolerability or exploratory PD endpoints with selected pharmacodynamic and safety parameters. 20 weeks
Trial Locations
- Locations (1)
GSK Investigational Site
🇬🇧London, United Kingdom