Safety, Tolerability and Pharmacokinetics of GSK1034702 in Healthy Subjects

NCT ID: NCT00743405

Last Updated: 2017-07-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-05-02
• Study Completion Date: 2008-12-15

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.

Conditions

Cognitive Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Cohort 1

Subjects will be receive GSK1034702 0.5 milligram (mg) following the dose escalation plan

Group Type: OTHER

GSK1034702

Intervention Type: DRUG

Oral or liquid

Placebo

Intervention Type: DRUG

To match GSK1034702

Cohort 2

Subjects will be receive GSK1034702 5 mg following the dose escalation plan

Group Type: OTHER

GSK1034702

Intervention Type: DRUG

Oral or liquid

Placebo

Intervention Type: DRUG

To match GSK1034702

Interventions

GSK1034702

Oral or liquid

Intervention Type: DRUG

Placebo

To match GSK1034702

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

London, , United Kingdom

Countries

United Kingdom

Other Identifiers

110623

Identifier Type: -

Identifier Source: org_study_id