GSK618334 Repeat Dose Study

GlaxoSmithKline46 enrolled

Overview

The proposed study will evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics of repeated oral doses of GSK618334 in healthy male and female volunteers.

GSK618334 strongly binds to dopamine type 3 receptors in the human brain and is being developed as an innovative treatment for substance dependence. This study will evaluate the safety, tolerability, blood concentrations and effect following repeated oral doses of GSK618334 in healthy male and female volunteers. The effect of food on a single oral dose of GSK618334 will also be evaluated. Another portion of this study will investigate dopamine type 3 receptor binding in the human brain by PET scan before and after repeated doses of GSK618334.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

DOUBLE

Enrollment

Conditions

Substance Dependence

Interventions

GSK618334 Low DoseDRUG

GSK618334 low dose

GSK618334 PET subjectsDRUG

PET subjects

GSK618334 Medium DoseDRUG

Medium Dose

GSK618334 High Dose

Eligibility

Sex: ALLMin age: 18 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy Males and Females between the ages of 18-50 years old * Male and Female subjects must agree to use protocol specified contraceptive methods. * Male subjects only in PET parts of the study. * Capable of providing written informed consent. Exclusion Criteria: * A positive test for Hepatitis B or Hepatitis C within 3 months of screening. * Current or chronic history of liver disease, or known liver/bile/gallbladder abnormalities. * Personal or family history of heart disease (such as irregular heart beats, a history of sudden unexplained death in a first degree relative, or unexplained fainting). * Screening ECG parameters outside the protocol specified parameters. * Pulse rate \<50 or \>100 bpm OR a systolic blood pressure \>140 or \<95 mmHg OR a diastolic blood pressure \>90 or \<50 mmHg at screening and/or baseline. * Pregnant or lactating females. * Exposure to more than four new chemical entities within 12 months prior to the first dosing day. * Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56 day period. * Previous inclusion in a research and/or medical protocol involving nuclear medicine, PET or radiological investigations with significant radiation burden. * Significant suicidal risk.

Locations (1)

GSK Investigational Site

London, United Kingdom

Outcomes

Primary Outcomes

The safety and tolerability endpoints will be: adverse events, laboratory values, cardiovascular variables (blood pressure, heart rate, ECG), temperature, respiratory rate, assessment of mood and abnormal movements, and GSK618334 blood levels.

Time frame: First dose to follow-up

To assess blood concentrations of GSK618334 after repeated oral doses.

Time frame: First dose to 72 hours post last dose

Secondary Outcomes

To assess the effect of food on GSK618334 blood concentrations after a single dose.

Time frame: First dose of the single dose session to 24 hours after dosing of the repeat dose session

The dopamine type 3 receptor binding in the brain (by PET scan) of GSK618334 following the repeat dose session.

Time frame: First dose to 24 hours after last dose

Data from ClinicalTrials.gov

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