Substance DependencePhase 1NCT01039454
Effects of the D3 Antagonist GSK598809 on Food Reward and Reinforcement
A Phase 1 study testing GSK598809 Capsules in people with Substance Dependence, run by GlaxoSmithKline at 2 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Substance Dependence
- What is being tested?
- GSK598809 Capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 18 Dec 2008to 26 Apr 2010
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- generally healthy
- right handed
- binge eating episode
- use appropriate contraception method
- willing to see a dietician
- overweight or obese (BMI 27 - 40 kg/m2)
Who cannot join
- 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
Show all 11Show fewer
- 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 locations and contacts
2 sites in 1 country.
United Kingdom2 sites
GSK Investigational Site
Cambridge, Cambridgeshire, CB2 0QQ
GSK Investigational Site
London, NW10 7EW
About this study
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.
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.
Read the 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
- Being tested
- GSK598809 Capsules, GSK598809 Placebo Capsules
- Keywords
- Food Reward, fMRI, Obese, Cognition, Food Addiction, Behaviour, Overweight, Food Reinforcement, Metabolic endpoints
- Medical subject headings
- Substance-Related Disorders, Obesity, Food Addiction, Behavior, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GSK598809 CapsulesDrug
GSK598809 is being developed for the treatment of substance dependence and potentially other impulse control disorders.
GSK598809 Placebo CapsulesDrug
Treatment of substance dependence and potentially other impulse control disorders.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | 2 way cross over. Receives: Drug: GSK598809 Placebo Capsules |
| Active | Active comparator | 2 Way cross over Receives: Drug: GSK598809 Capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional MRI: Food Processing Task, Food-Stop Signal Task, Food Stroop Task
Measured: 9 weeks
Behavioural Neurocognitive Task: Visual Probe Task, Stimulus Response Compatibility Task, Pavlovian-Instrumental Task.
Measured: 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
Measured: 9 weeks
PK endpoints: AUC, Cmax, tmax, t1/2
Measured: 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
Measured: 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Dec 2009 (estimated)
- Study start18 Dec 2008
- Primary completion26 Apr 2010
- Study completion26 Apr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance DependenceStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01039454
- Sponsor's protocol ID
- 109710
- Status last verified
- Jun 2017
- First submitted
- 10 Dec 2009
- Last updated
- 20 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01039454
- Acronym / sponsor ID
- 109710
- Conditions
- Substance Dependence
- Keywords
- Food Reward, fMRI, Obese, Cognition, Food Addiction, Behaviour, Overweight, Food Reinforcement
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 18 Dec 2008 (actual)
- Primary completion
- 26 Apr 2010 (actual)
- Study completion
- 26 Apr 2010 (actual)
- First posted
- 25 Dec 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: GSK598809 Placebo Capsules2 way cross over. |
| Active | Active comparator | Drug: GSK598809 Capsules2 Way cross over |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- generally healthy
- right handed
- binge eating episode
- use appropriate contraception method
- willing to see a dietician
Key exclusion criteria (11 listed)
- pregnant or breast feeding female
- recent weight loss or gain
- recent use of weight loss drugs
- surgery for obesity
- abuse alcohol or drugs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GSK598809 CapsulesGSK598809 is being developed for the treatment of substance dependence and potentially other impulse control disorders. | Drug | Active |
| GSK598809 Placebo CapsulesTreatment of substance dependence and potentially other impulse control disorders. | Drug | Placebo |
Primary outcome
Functional MRI: Food Processing Task, Food-Stop Signal Task, Food Stroop Task
Time frame: 9 weeks
Behavioural Neurocognitive Task: Visual Probe Task, Stimulus Response Compatibility Task, Pavlovian-Instrumental Task.
Time frame: 9 weeks
3 secondary outcomes
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2017.
- Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
- Results for study 109710 can be found on the GSK Clinical Study Register.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GSK598809 Capsules in people with Substance Dependence, run by GlaxoSmithKline at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional MRI: Food Processing Task, Food-Stop Signal Task, Food Stroop Task (time frame: 9 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jun 2017.