Effects of the D3 Antagonist GSK598809 on Food Reward and Reinforcement

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01039454
First received: December 10, 2009
Last updated: January 22, 2011
Last verified: January 2011
  Purpose

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.


Condition Intervention Phase
Food Addiction
Substance Dependence
Obesity
Overweight
Drug: GSK598809 Capsules
Drug: GSK598809 Placebo Capsules
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Single-blind, Randomized, Placebo Controlled, Two-period Crossover fMRI Study to Investigate the Effects of the D3 Antagonist GSK598809 on Neural and Behavioural Responses to Food Reward and Reinforcement After a Single Oral Dose of GSK598809 in Overweight and Obese Subjects

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Functional MRI: Food Processing Task, Food-Stop Signal Task, Food Stroop Task [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]
  • Behavioural Neurocognitive Task: Visual Probe Task, Stimulus Response Compatibility Task, Pavlovian-Instrumental Task. [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Appetite VAS, Bond and Lader VAS, Distress VAS, BIS II, TFEQ, BIS/BAS, BDI-II, Body weight, Metabolic markers: plasma leptin, ghrelin, alpa MSH [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]
  • PK endpoints: AUC, Cmax, tmax, t1/2 [ Time Frame: 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 [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 24
Study Start Date: December 2008
Study Completion Date: April 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
2 way cross over.
Drug: GSK598809 Placebo Capsules
Treatment of substance dependence and potentially other impulse control disorders.
Active Comparator: Active
2 Way cross over
Drug: GSK598809 Capsules
GSK598809 is being developed for the treatment of substance dependence and potentially other impulse control disorders.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01039454

Locations
United Kingdom
GSK Investigational Site
Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ
GSK Investigational Site
London, United Kingdom, NW10 7EW
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: E.D. Derilus; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT01039454     History of Changes
Other Study ID Numbers: 109710
Study First Received: December 10, 2009
Last Updated: January 22, 2011
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by GlaxoSmithKline:
Food Reward
fMRI
Obese
Cognition
Food Addiction
Behaviour
Overweight
Food Reinforcement
Metabolic endpoints

Additional relevant MeSH terms:
Overweight
Substance-Related Disorders
Body Weight
Signs and Symptoms
Chemically-Induced Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 18, 2014