Effects of the D3 Antagonist GSK598809 on Food Reward and Reinforcement

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 1

Conditions: Substance Dependence

Treatments: Drug: GSK598809 Capsules; Drug: GSK598809 Placebo Capsules

Study type: Interventional

Funder types: Industry

Identifiers

NCT01039454

109710

Details and patient eligibility

About

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.

Full 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.

Enrollment: 24 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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24 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

2 way cross over.

Treatment:

Drug: GSK598809 Placebo Capsules

Active

Active Comparator group

Description:

2 Way cross over

Treatment:

Drug: GSK598809 Capsules