Safety, Tolerability and Pharmacokinetics of GSK1034702 in Healthy Subjects

• Status: Completed
• Trial end date: 2008-12-15
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: GlaxoSmithKline

Criteria

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.