Effects of the D3 Antagonist GSK598809 on Food Reward and Reinforcement

NCT ID: NCT01039454

Last Updated: 2017-06-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-12-18
• Study Completion Date: 2010-04-26

Brief Summary

This novel compound is a new experimental treatment that may help people to stop compulsive overeating. Compulsive overeating or binge eating is one of the main reasons why people are overweight or obese. Recent research has shown that some kinds of overeating may be linked to a brain chemical called dopamine. There is some evidence that blocking the action of this chemical in animals can reduce food intake, particularly of foods that are high in fat and sugar. The purpose of this study is to find out if this compound (which blocks the effects of dopamine) has the same effect in overweight or obese people, as it does in animals.

Detailed Description

This novel compound is being developed for the treatment of substance dependence and potentially other impulse control disorders.

This is an fMRI study designed to examine the behavioural and physiological effects of a single dose of novel compound on food reward and reinforcement in relation to food seeking behaviour under conditions of fasting, using fMRI, neurocognitive and metabolic endpoints in overweight and obese subjects. These main objectives will be evaluated in the principal part of the study, Part A. The study will also consist of a follow up period of weight management with a dietician where exploratory objectives are considered, Part B.

Part A, will be a single-blind, randomised, placebo controlled, multi-centre, two-period cross-over study. Approximately 24 subjects will be enrolled such that a minimum of 20 subjects complete dosing and critical assessments. All subjects will be required to complete questionnaires, perform a series of behavioural tasks and scanning procedures. Safety and tolerability will be assessed by monitoring subjects for adverse events, vital signs, ECGs, movement disorders (EPS, Akathisia) and laboratory parameters. The pharmacokinetic profile of the compound in this subject population will be determined by blood sampling over a 72 hour period post dosing, in both sessions. Part B will consist of 12 weeks weight management directed by a dietician on an outpatient basis. Subjects will have fortnightly visits with a dietician and at the end of the 12 weeks complete three questionnaires (TFEQ-18R, DBEQ and YBOCS-BE) and have their weight measured to assess weight loss.

Conditions

Substance Dependence

Study Design

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

Study Groups

Placebo

2 way cross over.

Group Type: PLACEBO_COMPARATOR

GSK598809 Placebo Capsules

Intervention Type: DRUG

Treatment of substance dependence and potentially other impulse control disorders.

Active

2 Way cross over

Group Type: ACTIVE_COMPARATOR

GSK598809 Capsules

Intervention Type: DRUG

GSK598809 is being developed for the treatment of substance dependence and potentially other impulse control disorders.

Interventions

GSK598809 Capsules

GSK598809 is being developed for the treatment of substance dependence and potentially other impulse control disorders.

Intervention Type: DRUG

GSK598809 Placebo Capsules

Treatment of substance dependence and potentially other impulse control disorders.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• generally healthy
• right handed
• binge eating episode
• use appropriate contraception method
• willing to see a dietician
• overweight or obese (BMI 27 - 40 kg/m2)

Exclusion Criteria

• pregnant or breast feeding female
• recent weight loss or gain
• recent use of weight loss drugs
• surgery for obesity
• abuse alcohol or drugs
• cannot do MRI scans
• smokers
• certain emotional problems being treated with medications
• medical, surgical or neuropsychiatric illness
• ECG abnormality
• sudden unexplained death or syncope in first degree relatives

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 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

Cambridge, Cambridgeshire, United Kingdom

GSK Investigational Site

London, , United Kingdom

Countries

United Kingdom

Study Documents

Document Type: Individual Participant Data Set

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Clinical Study Report

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Informed Consent Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Study Protocol

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Dataset Specification

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Statistical Analysis Plan

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Related Links

https://www.clinicalstudydatarequest.com

Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Other Identifiers

109710

Identifier Type: -

Identifier Source: org_study_id