Effects of the D3 Antagonist GSK598809 on Food Reward and Reinforcement

NCT01039454 | Completed Phase 1

• 1 other identifier: 109710
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 2

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.

Conditions

Substance Dependence

Keywords

Food Reward; fMRI; Obese; Cognition; Food Addiction; Behaviour; Overweight; Food Reinforcement; Metabolic endpoints

Outcome Measures

Primary Outcomes (2)

• Functional MRI: Food Processing Task, Food-Stop Signal Task, Food Stroop Task

  9 weeks

• Behavioural Neurocognitive Task: Visual Probe Task, Stimulus Response Compatibility Task, Pavlovian-Instrumental Task.

  9 weeks

Secondary Outcomes (3)

• Appetite VAS, Bond and Lader VAS, Distress VAS, BIS II, TFEQ, BIS/BAS, BDI-II, Body weight, Metabolic markers: plasma leptin, ghrelin, alpa MSH

  9 weeks

• PK endpoints: AUC, Cmax, tmax, t1/2

  9 weeks

• Safety and tolerability: adverse events, laboratory values, cardiovascular - blood pressure; heart rate; ECGs, movement disorders, temperature, respiratory rate, serum prolactin, GH and TSH

  9 weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR

2 way cross over.

Drug: GSK598809 Placebo Capsules

Active

ACTIVE COMPARATOR

2 Way cross over

Drug: GSK598809 Capsules

Interventions

GSK598809 Capsules DRUG

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

Active

GSK598809 Placebo Capsules DRUG

Treatment of substance dependence and potentially other impulse control disorders.

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (2)

GSK Investigational Site

Cambridge, Cambridgeshire, CB2 0QQ, United Kingdom

Location

GSK Investigational Site

London, NW10 7EW, United Kingdom

Location

Related Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
• Results for study 109710 can be found on the GSK Clinical Study Register.

MeSH Terms

Conditions

Substance-Related Disorders; Obesity; Food Addiction; Behavior; Overweight

Interventions

GSK598809

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior, Addictive; Compulsive Behavior; Impulsive Behavior; Feeding and Eating Disorders

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2009
• First Posted: December 25, 2009
• Study Start: December 18, 2008
• Primary Completion: April 26, 2010
• Study Completion: April 26, 2010
• Last Updated: June 20, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will share

Locations

GB (2)