0 Ratings
ID

30546

Description

This ODM file contains Eligibility Criteria. To be filled in at Screening. Do an Inclusion/Exclusion Check at Sessions 1 and 2 (Day -1). Study ID: 109710 Clinical Study ID: DAN109710 Study 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. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01039454 https://clinicaltrials.gov/ct2/show/NCT01039454 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GSK598809 Trade Name: Study Indication: Substance Dependence 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.

Link

https://clinicaltrials.gov/ct2/show/NCT01039454

Keywords

Versions (1)
  1. 6/13/18 6/13/18 - Sarah Riepenhausen
Copyright Holder

GlaxoSmithKline

Uploaded on

June 13, 2018

DOI

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License

Creative Commons BY-NC 3.0
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    Effects of D3 antagonist GSK598809 on neural and behavioural responses to food reward/reinforcement after a single dose in overweight/obese subjects NCT01039454

    English

    Eligibility Criteria

    1 forms  
    1. StudyEvent: ODM
      1. Eligibility Criteria
    Administrative Data
    Description

    Administrative Data

    Alias
    UMLS CUI-1
    C1320722
    Type of Visit
    Description

    Visit

    Data type

    text

    Alias
    UMLS CUI [1]
    C0545082
    Date of Visit
    Description

    Date of Visit

    Data type

    date

    Alias
    UMLS CUI [1]
    C1320303
    Subject Identifier
    Description

    Subject Identifier

    Data type

    text

    Alias
    UMLS CUI [1]
    C2348585
    Eligibility Question
    Description

    Eligibility Question

    Alias
    UMLS CUI-1
    C0013893
    Did the subject meet all the entry criteria?
    Description

    To be answered at screening. If No, fill in the items of Inclusion and Exclusion criteria. Answer "no" corresponding to violations of any inclusion criteria, "yes" corresponding to violations of any Exclusion criteria. Do not enter the subject into the study if they failed any inclusion or exclusion criteria below.

    Data type

    text

    Alias
    UMLS CUI [1]
    C1302261
    Inclusion/Exclusion Criteria Check
    Description

    Inclusion/Exclusion Criteria Check

    Alias
    UMLS CUI-1
    C0013893
    Is the subject eligible to continue the study?
    Description

    To be answered at Day -1 of Sessions.

    Data type

    text

    Alias
    UMLS CUI [1]
    C1302261
    Inclusion Criteria
    Description

    Inclusion Criteria

    Alias
    UMLS CUI-1
    C1512693
    Healthy as determined by a responsible physician, based on a medical evaluation including medical history, physical examination, psychiatric history, psychiatric evaluation, laboratory tests and cardiac monitoring.
    Description

    A subject with a clinical abnormality or laboratory parameters outside the reference range for the population being studied may be included only if the Investigator and the GSK Medical Monitor agree that the finding is unlikely to compromise subject safety or interfere with study integrity. Subjects with elevated prolactin values outside the normal range should always be excluded from enrollment.

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1708335
    UMLS CUI [2,1]
    C0373706
    UMLS CUI [2,2]
    C0205307
    Male or female between 18 and 45 years of age inclusive.
    Description

    Selected to encompass subjects without significant chance of brain function decline due to age.

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0079399
    UMLS CUI [2]
    C0001779
    Subjects are eligible if they are willing to be referred to a dietician.
    Description

    Referral to dietician

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0420347
    Must be right handed.
    Description

    a requirement to ensure consistency of fMRI signals from the brain

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0344333
    A female subject is eligible to participate if she is of non-childbearing potential or if she agrees to use one of the listed contraception methods.
    Description

    Non-childbearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea [in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) > 40 MIU/ml and estradiol < 40 pg/ml (<140 pmol/L) is confirmatory]. Females on hormone replacement therapy (HRT) will not be included in the study. Child-bearing potential and agrees to use one of the contraception methods listed for an appropriate period of time (as determined by the product label or investigator) prior to the start of dosing to sufficiently minimize the risk of pregnancy at that point. Female subjects must agree to use contraception until 90 days after completion of the study. If female subjects are currently using oral or depot hormonal contraceptives, they may be enrolled but must also use one other form of contraception as listed. List of contraceptive methods with failure rate below 1 percent: * Abstinence: Sexual inactivity by abstinence must be consistent with the preferred and usual lifestyle of the subject. Periodic abstinence (e.g. calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception. * Intrauterine device (IUD) or intrauterine system (IUS) that meets the under 1 percent failure rate as stated in the product label. * Male partner sterilization (vasectomy with documentation of azoospermia) prior to the female subject's entry into the study, and this male is the sole partner for that subject. For this definition, “documented” refers to the outcome of the investigator's/designee’s medical examination of the subject or review of the subject's medical history for study eligibility, as obtained via a verbal interview with the subject or from the subject’s medical records. * Double barrier method: condom and occlusive cap (diaphragm or cervical/vault caps) plus spermicidal agent (foam/gel/film/cream/suppository).

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C3831118
    UMLS CUI [2]
    C0700589
    Male subjects must agree to use one of the contraception methods listed.
    Description

    This criterion must be followed from the time of the first dose of study medication until 90 days after completion of the study. List: * Abstinence, defined as sexual inactivity consistent with the preferred and usual lifestyle of the subject. Periodic abstinence (e.g. calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception. * Double barrier method: condom plus spermicidal agent (foam/gel/film/cream/suppository).

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0086580
    BMI within the range 27 – 40 kg/m2 (inclusive) and body habitus consistent with comfort during scanning.
    Description

    BMI 27-40, comfortable body habitus

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1305855
    UMLS CUI [2,1]
    C1318474
    UMLS CUI [2,2]
    C1331418
    Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
    Description

    (Capable of) Written informed consent, Compliance with study requirements

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0021430
    UMLS CUI [1,2]
    C2698977
    UMLS CUI [2,1]
    C0525058
    UMLS CUI [2,2]
    C2698977
    QTcB or QTcF < 450 msec.
    Description

    QTcB or QTcF < 450 msec.

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1882512
    UMLS CUI [2]
    C1882513
    Self-administered Beck Depression Inventory II scale total score no greater than 13, and suicide question score of zero.
    Description

    Beck Depression Inventory II < 13, Suicide question score = 0

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C4273555
    UMLS CUI [2,1]
    C0038661
    UMLS CUI [2,2]
    C0681889
    Subjects are eligible to take part in the study if they binge eat (i.e. minimum 1 binge episode per week).
    Description

    Binge eating

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0596170
    Subjects are eligible if they score at least 3 in at least one of questions of the emotional eating scale (Q3, Q6 and Q10) of the TFEQ-R18.
    Description

    TFEQ-R18 (Q3, Q6 and/or Q10 at least 3)

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0034394
    UMLS CUI [1,2]
    C0013473
    Exclusion Criteria
    Description

    Exclusion Criteria

    Alias
    UMLS CUI-1
    C0680251
    The subject has either a previous disease or current medical condition, which as judged by the Investigator, may affect the interpretation of efficacy data.
    Description

    These diseases include, but are not limited to, cardiovascular disease, malignancy, hepatic disease, renal disease, haematological disease, neurological disease, psychiatric diseases or endocrine disease.

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0009488
    UMLS CUI [1,2]
    C0392760
    UMLS CUI [1,3]
    C0459471
    A positive pre-study HIV, Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening.
    Description

    (with the exception of phase I hepatic impairment studies, oncology studies, hepatitis, hepatic fibrosis, or HIV studies).

    Data type

    text

    Alias
    UMLS CUI [1]
    C0149709
    UMLS CUI [2]
    C0281863
    UMLS CUI [3]
    C0920548
    The subject has a current closed angle glaucoma.
    Description

    closed angle glaucoma

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0017605
    The subject has prostatic hyperplasia.
    Description

    prostatic hyperplasia

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C2937421
    The subject has a known history of panic attacks and/or claustrophobia, or other conditions precluding MRI scans according to local guidelines.
    Description

    e.g. pacemaker, hearing aid, tattoos, metallic body piercing and/or other metal implants that cannot be removed.

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0024485
    UMLS CUI [1,2]
    C0522473
    The subject has a history or presence of other neurological or other psychiatric or other medical conditions that may influence the outcome or analysis of the scan results.
    Description

    Examples of such include, but are not limited to: schizophrenia or psychosis, major depressive disorder, anxiety disorders, stroke, traumatic brain injury, epilepsy, space occupying lesions, multiple sclerosis, Parkinson’s disease, vascular dementia, transient ischemic attack, rheumatoid arthritis and fibromyalgia syndrome.

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0009488
    UMLS CUI [1,2]
    C0024485
    UMLS CUI [1,3]
    C0004936
    UMLS CUI [1,4]
    C0024485
    UMLS CUI [1,5]
    C4054723
    UMLS CUI [2,1]
    C0027765
    UMLS CUI [2,2]
    C0024485
    UMLS CUI [2,3]
    C4054723
    The subject has a history of anorexia nervosa, binge-eating disorder without obesity or bulimia nervosa.
    Description

    Anorexia nervosa, Bulimia nervosa, Binge eating without obesity

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0003125
    UMLS CUI [2]
    C2267227
    UMLS CUI [3,1]
    C0596170
    UMLS CUI [3,2]
    C0028754
    UMLS CUI [3,3]
    C1298908
    The subject has a recent history of weight loss (or gain) defined as a change of >5 percent in the 3 months prior to screening or those who have lost >5 percent of their body weight in the past 30 days.
    Description

    Weight loss or gain > 5 percent in last 3 months

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0005911
    The subject has had surgical intervention for obesity.
    Description

    obesity surgery

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C2112820
    The subject has a history of alcohol or substance abuse or dependence in the 6 months prior to screening as determined by the investigator.
    Description

    Abuse of alcohol, defined for males, as an average weekly intake of greater than 21 units (or an average daily intake of greater than 3 units), or defined for females, as an average weekly intake of greater than 14 units (or an average daily intake of greater than 2 units). One unit is equivalent to a half-pint (220mL) of beer or 1 (25mL) measure of spirits or 1 glass (125mL) of wine.

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0085762
    UMLS CUI [2]
    C0038586
    UMLS CUI [3]
    C0038580
    UMLS CUI [4]
    C0740866
    Current smokers as determined by urinary cotinine levels indicative of smoking or history or regular use of tobacco- or nicotine-containing products within 6 months prior to screening.
    Description

    Cotinine levels, History of smoking

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1519384
    UMLS CUI [2]
    C0202363
    The subject has a positive urine drug test at screening or when tested at any of the study visits.
    Description

    Drug screen positive

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0743300
    The subject has a documented history of hepatobiliary disease or hepatic enzyme elevation including any one of the following: ALT or AST > 2 times upper limit of normal at screening or Day -1. Fasting triglycerides > 600mg/dL at screening or Day -1. Total bilirubin > 1.5 times the upper limit of normal at screening or Day -1.
    Description

    Subjects above this limit may only be included if direct bilirubin is within normal limits, which would be consistent with Gilbert’s disease.

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1278039
    UMLS CUI [2]
    C0201899
    UMLS CUI [3]
    C0201836
    UMLS CUI [4]
    C0582824
    If a subject is receiving lipid-lowering therapy (i.e. statins).
    Description

    Lipid-lowering therapy

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0585943
    The subject has known type 1 or type 2 diabetes mellitus; or has fasting plasma glucose >140mg/dL (7.5mmol/L) at screening, or is on an oral glycemic agent.
    Description

    Diabetes mellitus Type 1/2, fasting plasma glucose, oral glycemic agent

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0011860
    UMLS CUI [2]
    C0011854
    UMLS CUI [3]
    C0583513
    UMLS CUI [4]
    C0421247
    The subject at screening has systolic blood pressure (BP) below 90 or above 150mmHg, or diastolic blood pressure (BP) below 50 or above 100 mmHg.
    Description

    Systolic or diastolic blood pressure above/below limits

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0871470
    UMLS CUI [2]
    C0428883
    Planning to commence or stop hormone replacement therapy (HRT) or oral contraceptives during the course of the study.
    Description

    Female subjects who are taking an oral contraceptive preparation at the time of screening may be eligible for enrolment in the study, however they must use additional forms of contraception.

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0009905
    UMLS CUI [2]
    C3274784
    UMLS CUI [3]
    C3274784
    UMLS CUI [4]
    C0850893
    The subject is pregnant (as determined by positive serum or urine hCG test at screening or prior to dosing) or planning a pregnancy in the following 27 weeks from screening.
    Description

    current or planned pregnancy, hCG test

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0032961
    UMLS CUI [1,2]
    C0546577
    UMLS CUI [2]
    C0032992
    Lactating females or lactating within the last month.
    Description

    Lactating

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C2828358
    The subject has concomitant medications usage that includes medication listed in the description.
    Description

    * use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John's Wort) within 14 days prior to the first dose of study medication with the exception of occasional non-daily use of acetaminophen, or non-steroidal anti-inflammatory agents. * Use of weight loss drugs within three months of the first dose of the marketed drug. * Use of any oral anti-diabetic medication (including metformin, sulphonylureas, thiazolidinedione, GLP-1 agonist, DDP-IV inhibitors). * Use of antidepressants or anxiolytics (selective serotonin re-uptake inhibitor (SSRI), tricyclic, buprion, sedatives, hypnotics) on any basis other than occasional within 6 months of screening. * Use of antipsychotics (i.e. D2 antagonists) or any dopamine agonists (i.e. bromocriptine, pergolide) or Parkinson’s disease medications (L-DOPA) ever * Use of diuretics, systemic corticosteroids (inhaled and intranasal corticosteroids are permitted), or any other medication within 3 weeks prior to any scheduled dose of study medication that may result in electrolyte depletion. * Use of macrolide antibiotics during the interventional part of the study. Medications not allowed: At least 6 months prior to the Baseline Visit: All antidepressants, Lithium At least 2 weeks prior to Baseline visit (or 5 half-lives whichever is longer): Psychoactive herbal or nutritional treatment (e.g., St. John's Wort, SAM-e), Opiates, hypnotics, anxiolytics, and all other sedatives (including as needed benzodiazepines as sleep aids), Systemic corticosteroids (NOTE: Topical hydrocortisone, inhaled and nasal corticosteroids are allowed). Concomitant medications that are known potent or moderate inducers or inhibitors of CYP3A4/5 for 14 days prior to administration randomization through 14 days after the last dose of investigational product: CYP3A4/5 Inhibitors: atazanavir, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, amprenavir, aprepitant, diltiazem, erythromycin, fluconazole, fosamprenavir, grapefruit juice, verapamil (Intermittent use of topical/vaginal antifungal medications are permitted), CYP3A4/5 Inducers: carbamazepine, phenobarbitol, phenytoin, rifabutin, rifampicin, St John’s Wort. Please note that this is not an exhaustive list.

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C2347852
    The subject has used any investigational drug or device in the 30 days prior to first dose of study medication or was exposed to more than four new chemical entities within 12 months prior to the first dosing day.
    Description

    Investigational drug or device in last 12 months

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C2348568
    UMLS CUI [1,2]
    C0013230
    UMLS CUI [1,3]
    C2346570
    History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or GSK Medical Monitor, contraindicates their participation.
    Description

    Sensitivity to study medication, other (drug) allergy

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0020517
    UMLS CUI [1,2]
    C0304229
    UMLS CUI [2]
    C0013182
    UMLS CUI [3]
    C0020517
    Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56 day period.
    Description

    Study participation resulting in Blood donation

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0005794
    UMLS CUI [1,2]
    C2348568
    Consumption of red wine, seville oranges, grapefruit or grapefruit juice from 7 days prior to the first dose of study medication.
    Description

    Red wine, seville oranges, grapefruit (juice)

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0995150
    UMLS CUI [2]
    C0452456
    UMLS CUI [3]
    C0349371
    UMLS CUI [4]
    C0330922
    The subject has a serum prolactin at screening exceeding the normal range.
    Description

    Serum Prolactin

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0373706
    Positive history of psychiatric disorder by DSM-IV Axis I or II, or positive findings on psychiatric evaluation other than binge eating that does not meet the DSM-IV diagnostic criteria for binge eating disorder.
    Description

    DSM-IV Axis I or II

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0270287
    UMLS CUI [1,2]
    C0220952
    UMLS CUI [2,1]
    C0270288
    UMLS CUI [2,2]
    C0220952
    UMLS CUI [3]
    C0596170
    The subject has personal or family history of prolonged QTc, a personal history of arrhythmia, a history of sudden unexplained death in a first degree relative, or unexplained syncope in a first degree relative.
    Description

    QTc prolonged, arrhythmia, sudden unexplained death/syncope in first degree relative

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1969409
    UMLS CUI [2,1]
    C0011071
    UMLS CUI [2,2]
    C1517194
    UMLS CUI [3,1]
    C1517194
    UMLS CUI [3,2]
    C0039070
    UMLS CUI [4]
    C0003811
    Unwillingness or inability to follow the procedures outlined in the protocol.
    Description

    Protocol compliance unwilling/unable

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0525058
    UMLS CUI [1,2]
    C0558080
    UMLS CUI [2,1]
    C0525058
    UMLS CUI [2,2]
    C1299582
    The subject has healthy food preferences (including vegetarians) based on a food preference questionnaire.
    Description

    Healthy food preference

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0016483
    UMLS CUI [1,2]
    C3898900
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    Eligibility Criteria

    1 forms
    1. StudyEvent: ODM
      1. Eligibility Criteria
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Administrative Data
    C1320722 (UMLS CUI-1)
    Item
    Type of Visit
    text
    C0545082 (UMLS CUI [1])
    Visit
    Code List
    Type of Visit
    CL Item
    Screening (Screening)
    (Comment:en)
    CL Item
    Session 1 (Day -1) (Session 1)
    (Comment:en)
    CL Item
    Session 2 (Day -1) (Session 2)
    (Comment:en)
    Date of Visit
    Item
    Date of Visit
    date
    C1320303 (UMLS CUI [1])
    Subject Identifier
    Item
    Subject Identifier
    text
    C2348585 (UMLS CUI [1])
    Item Group
    Eligibility Question
    C0013893 (UMLS CUI-1)
    Item
    Did the subject meet all the entry criteria?
    text
    C1302261 (UMLS CUI [1])
    Eligible
    Code List
    Did the subject meet all the entry criteria?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Item Group
    Inclusion/Exclusion Criteria Check
    C0013893 (UMLS CUI-1)
    Item
    Is the subject eligible to continue the study?
    text
    C1302261 (UMLS CUI [1])
    Eligible
    Code List
    Is the subject eligible to continue the study?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Item Group
    Inclusion Criteria
    C1512693 (UMLS CUI-1)
    Healthy with normal prolactin values
    Item
    Healthy as determined by a responsible physician, based on a medical evaluation including medical history, physical examination, psychiatric history, psychiatric evaluation, laboratory tests and cardiac monitoring.
    boolean
    C1708335 (UMLS CUI [1])
    C0373706 (UMLS CUI [2,1])
    C0205307 (UMLS CUI [2,2])
    Gender, Age
    Item
    Male or female between 18 and 45 years of age inclusive.
    boolean
    C0079399 (UMLS CUI [1])
    C0001779 (UMLS CUI [2])
    Referral to dietician
    Item
    Subjects are eligible if they are willing to be referred to a dietician.
    boolean
    C0420347 (UMLS CUI [1])
    Right handed
    Item
    Must be right handed.
    boolean
    C0344333 (UMLS CUI [1])
    Non-childbearing potential or contraception method
    Item
    A female subject is eligible to participate if she is of non-childbearing potential or if she agrees to use one of the listed contraception methods.
    boolean
    C3831118 (UMLS CUI [1])
    C0700589 (UMLS CUI [2])
    Male: Contraception methods
    Item
    Male subjects must agree to use one of the contraception methods listed.
    boolean
    C0086580 (UMLS CUI [1])
    BMI 27-40, comfortable body habitus
    Item
    BMI within the range 27 – 40 kg/m2 (inclusive) and body habitus consistent with comfort during scanning.
    boolean
    C1305855 (UMLS CUI [1])
    C1318474 (UMLS CUI [2,1])
    C1331418 (UMLS CUI [2,2])
    (Capable of) Written informed consent, Compliance with study requirements
    Item
    Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
    boolean
    C0021430 (UMLS CUI [1,1])
    C2698977 (UMLS CUI [1,2])
    C0525058 (UMLS CUI [2,1])
    C2698977 (UMLS CUI [2,2])
    QTcB or QTcF < 450 msec.
    Item
    QTcB or QTcF < 450 msec.
    boolean
    C1882512 (UMLS CUI [1])
    C1882513 (UMLS CUI [2])
    Beck Depression Inventory II < 13, Suicide question score = 0
    Item
    Self-administered Beck Depression Inventory II scale total score no greater than 13, and suicide question score of zero.
    boolean
    C4273555 (UMLS CUI [1])
    C0038661 (UMLS CUI [2,1])
    C0681889 (UMLS CUI [2,2])
    Binge eating
    Item
    Subjects are eligible to take part in the study if they binge eat (i.e. minimum 1 binge episode per week).
    boolean
    C0596170 (UMLS CUI [1])
    TFEQ-R18 (Q3, Q6 and/or Q10 at least 3)
    Item
    Subjects are eligible if they score at least 3 in at least one of questions of the emotional eating scale (Q3, Q6 and Q10) of the TFEQ-R18.
    boolean
    C0034394 (UMLS CUI [1,1])
    C0013473 (UMLS CUI [1,2])
    Item Group
    Exclusion Criteria
    C0680251 (UMLS CUI-1)
    Disease affecting interpretation of efficacy
    Item
    The subject has either a previous disease or current medical condition, which as judged by the Investigator, may affect the interpretation of efficacy data.
    boolean
    C0009488 (UMLS CUI [1,1])
    C0392760 (UMLS CUI [1,2])
    C0459471 (UMLS CUI [1,3])
    HIV, Hepatitis B surface antigen, Hepatits C antibody: positive
    Item
    A positive pre-study HIV, Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening.
    text
    C0149709 (UMLS CUI [1])
    C0281863 (UMLS CUI [2])
    C0920548 (UMLS CUI [3])
    closed angle glaucoma
    Item
    The subject has a current closed angle glaucoma.
    boolean
    C0017605 (UMLS CUI [1])
    prostatic hyperplasia
    Item
    The subject has prostatic hyperplasia.
    boolean
    C2937421 (UMLS CUI [1])
    MRI contraindication
    Item
    The subject has a known history of panic attacks and/or claustrophobia, or other conditions precluding MRI scans according to local guidelines.
    boolean
    C0024485 (UMLS CUI [1,1])
    C0522473 (UMLS CUI [1,2])
    Psychiatric/neurological/medical condition influencing outcome or MRI analysis
    Item
    The subject has a history or presence of other neurological or other psychiatric or other medical conditions that may influence the outcome or analysis of the scan results.
    boolean
    C0009488 (UMLS CUI [1,1])
    C0024485 (UMLS CUI [1,2])
    C0004936 (UMLS CUI [1,3])
    C0024485 (UMLS CUI [1,4])
    C4054723 (UMLS CUI [1,5])
    C0027765 (UMLS CUI [2,1])
    C0024485 (UMLS CUI [2,2])
    C4054723 (UMLS CUI [2,3])
    Anorexia nervosa, Bulimia nervosa, Binge eating without obesity
    Item
    The subject has a history of anorexia nervosa, binge-eating disorder without obesity or bulimia nervosa.
    boolean
    C0003125 (UMLS CUI [1])
    C2267227 (UMLS CUI [2])
    C0596170 (UMLS CUI [3,1])
    C0028754 (UMLS CUI [3,2])
    C1298908 (UMLS CUI [3,3])
    Weight loss or gain > 5 percent in last 3 months
    Item
    The subject has a recent history of weight loss (or gain) defined as a change of >5 percent in the 3 months prior to screening or those who have lost >5 percent of their body weight in the past 30 days.
    boolean
    C0005911 (UMLS CUI [1])
    obesity surgery
    Item
    The subject has had surgical intervention for obesity.
    boolean
    C2112820 (UMLS CUI [1])
    Alcohol or substance abuse or dependence
    Item
    The subject has a history of alcohol or substance abuse or dependence in the 6 months prior to screening as determined by the investigator.
    boolean
    C0085762 (UMLS CUI [1])
    C0038586 (UMLS CUI [2])
    C0038580 (UMLS CUI [3])
    C0740866 (UMLS CUI [4])
    Cotinine levels, History of smoking
    Item
    Current smokers as determined by urinary cotinine levels indicative of smoking or history or regular use of tobacco- or nicotine-containing products within 6 months prior to screening.
    boolean
    C1519384 (UMLS CUI [1])
    C0202363 (UMLS CUI [2])
    Drug screen positive
    Item
    The subject has a positive urine drug test at screening or when tested at any of the study visits.
    boolean
    C0743300 (UMLS CUI [1])
    ALT, AST, Fasting TAG, total bilirubin
    Item
    The subject has a documented history of hepatobiliary disease or hepatic enzyme elevation including any one of the following: ALT or AST > 2 times upper limit of normal at screening or Day -1. Fasting triglycerides > 600mg/dL at screening or Day -1. Total bilirubin > 1.5 times the upper limit of normal at screening or Day -1.
    boolean
    C1278039 (UMLS CUI [1])
    C0201899 (UMLS CUI [2])
    C0201836 (UMLS CUI [3])
    C0582824 (UMLS CUI [4])
    Lipid-lowering therapy
    Item
    If a subject is receiving lipid-lowering therapy (i.e. statins).
    boolean
    C0585943 (UMLS CUI [1])
    Diabetes mellitus Type 1/2, fasting plasma glucose, oral glycemic agent
    Item
    The subject has known type 1 or type 2 diabetes mellitus; or has fasting plasma glucose >140mg/dL (7.5mmol/L) at screening, or is on an oral glycemic agent.
    boolean
    C0011860 (UMLS CUI [1])
    C0011854 (UMLS CUI [2])
    C0583513 (UMLS CUI [3])
    C0421247 (UMLS CUI [4])
    Systolic or diastolic blood pressure above/below limits
    Item
    The subject at screening has systolic blood pressure (BP) below 90 or above 150mmHg, or diastolic blood pressure (BP) below 50 or above 100 mmHg.
    boolean
    C0871470 (UMLS CUI [1])
    C0428883 (UMLS CUI [2])
    Start/Stop HRT or oral contraceptives
    Item
    Planning to commence or stop hormone replacement therapy (HRT) or oral contraceptives during the course of the study.
    boolean
    C0009905 (UMLS CUI [1])
    C3274784 (UMLS CUI [2])
    C3274784 (UMLS CUI [3])
    C0850893 (UMLS CUI [4])
    current or planned pregnancy, hCG test
    Item
    The subject is pregnant (as determined by positive serum or urine hCG test at screening or prior to dosing) or planning a pregnancy in the following 27 weeks from screening.
    boolean
    C0032961 (UMLS CUI [1,1])
    C0546577 (UMLS CUI [1,2])
    C0032992 (UMLS CUI [2])
    Lactating
    Item
    Lactating females or lactating within the last month.
    boolean
    C2828358 (UMLS CUI [1])
    Concomitant medication
    Item
    The subject has concomitant medications usage that includes medication listed in the description.
    boolean
    C2347852 (UMLS CUI [1])
    Investigational drug or device in last 12 months
    Item
    The subject has used any investigational drug or device in the 30 days prior to first dose of study medication or was exposed to more than four new chemical entities within 12 months prior to the first dosing day.
    boolean
    C2348568 (UMLS CUI [1,1])
    C0013230 (UMLS CUI [1,2])
    C2346570 (UMLS CUI [1,3])
    Sensitivity to study medication, other (drug) allergy
    Item
    History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or GSK Medical Monitor, contraindicates their participation.
    boolean
    C0020517 (UMLS CUI [1,1])
    C0304229 (UMLS CUI [1,2])
    C0013182 (UMLS CUI [2])
    C0020517 (UMLS CUI [3])
    Study participation resulting in Blood donation
    Item
    Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56 day period.
    boolean
    C0005794 (UMLS CUI [1,1])
    C2348568 (UMLS CUI [1,2])
    Red wine, seville oranges, grapefruit (juice)
    Item
    Consumption of red wine, seville oranges, grapefruit or grapefruit juice from 7 days prior to the first dose of study medication.
    boolean
    C0995150 (UMLS CUI [1])
    C0452456 (UMLS CUI [2])
    C0349371 (UMLS CUI [3])
    C0330922 (UMLS CUI [4])
    Serum Prolactin
    Item
    The subject has a serum prolactin at screening exceeding the normal range.
    boolean
    C0373706 (UMLS CUI [1])
    DSM-IV Axis I or II
    Item
    Positive history of psychiatric disorder by DSM-IV Axis I or II, or positive findings on psychiatric evaluation other than binge eating that does not meet the DSM-IV diagnostic criteria for binge eating disorder.
    boolean
    C0270287 (UMLS CUI [1,1])
    C0220952 (UMLS CUI [1,2])
    C0270288 (UMLS CUI [2,1])
    C0220952 (UMLS CUI [2,2])
    C0596170 (UMLS CUI [3])
    QTc prolonged, arrhythmia, sudden unexplained death/syncope in first degree relative
    Item
    The subject has personal or family history of prolonged QTc, a personal history of arrhythmia, a history of sudden unexplained death in a first degree relative, or unexplained syncope in a first degree relative.
    boolean
    C1969409 (UMLS CUI [1])
    C0011071 (UMLS CUI [2,1])
    C1517194 (UMLS CUI [2,2])
    C1517194 (UMLS CUI [3,1])
    C0039070 (UMLS CUI [3,2])
    C0003811 (UMLS CUI [4])
    Protocol compliance unwilling/unable
    Item
    Unwillingness or inability to follow the procedures outlined in the protocol.
    boolean
    C0525058 (UMLS CUI [1,1])
    C0558080 (UMLS CUI [1,2])
    C0525058 (UMLS CUI [2,1])
    C1299582 (UMLS CUI [2,2])
    Healthy food preference
    Item
    The subject has healthy food preferences (including vegetarians) based on a food preference questionnaire.
    boolean
    C0016483 (UMLS CUI [1,1])
    C3898900 (UMLS CUI [1,2])
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