Effect of a CCK-1R Agonist on Food Intake in Humans
Condition: Bulimia
MeSH terms: Bulimia
Intervention: GSKI181771X (CCK-1R agonist); Instructions to binge eat; Instructions to eat normally; Placebo
Intervention description: Drug one trial vs placebo; Subjects will be instructed to binge eat and will also be given either drug or placebo; Subjects will be instructed to eat normally and will also be given either drug or placebo; Drug one trial vs placebo
Phase: Phase 2
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 40.0
Sex: Female
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Eating; Food Intake; Appetite

Summary:

      The ultimate aim of this study is to test the hypothesis that the oral cholecystokinin (CCK)
      agonist GSKI181771X will reduce the size of a binge meal among individuals with Bulimia
      Nervosa. The study will be conducted in phases. First, an effective dose for reducing food
      intake, when normal subjects eat normally will be attained. Next, it will be determined
      whether intake at this dose is reduced in control subjects instructed to eat to capacity. If
      the dose is still effective compared to placebo, the same dose will be tested in patients
      with bulimia nervosa.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Both controls and patients will be female, 18 to 45 years old, and within 80-120% of
             ideal body weight (Metropolitan Life Insurance, 1983). Inclusion and exclusion will be
             evaluated using the following guidelines:

        Normal Controls:

          -  No current or past psychiatric illness

          -  No history of binge eating or vomiting

          -  80-120% ideal weight

          -  Of non-childbearing potential (i.e. physiologically incapable of becoming pregnant or
             surgically sterile)

          -  If of childbearing potential, willing to use an acceptable method of birth-control
             (please see list in "Exclusion" section)

        Patients with Bulimia Nervosa:

          -  DSM-IV (diagnostic statistical manual - American Psychiatric Association) criteria for
             bulimia nervosa

          -  Duration of illness > 1 year

          -  Purging after binges via self-induced vomiting

        (Same as controls for remaining inclusion criteria)

        Exclusion Criteria:

        Normal Controls:

          -  Significant medical illness: CBC, Chem-1, serum electrolytes (sodium, potassium,
             chloride, CO2), glucose, BUN (blood urea nitrogen), creatinine, Alk Phos, ALT (SGPT),
             AST (SGOT), LDH, total bilirubin, total protein, albumin, globulin, A/G ratio,
             calcium, phosphorus, uric acid, cholesterol, triglyceride

          -  ALT outside of upper limit of normal: Chem-1

          -  History of gallstones, pancreatitis or cholecystitis

          -  Current medication

          -  Hypersensitivity to benzodiazepines (contraindication in DCSI v02, 1-March-2006)

          -  Drug or alcohol abuse in last 3 mts

          -  Pregnancy

          -  Unable or unwilling to use highly effective methods of contraception for the duration
             of the study until an insignificant amount of the investigational product remains in
             the subject (i.e. at least 5 terminal phase half-lives). Examples of highly effective
             methods of contraception are:

               -  Implants of levonorgestrel, or

               -  Injectable progestogen, or

               -  Oral birth control pills for at least 3 monthly cycles prior to administration of
                  study drug + continuation for 24 hrs after last dose of study drug, or

               -  Double-barrier method (e.g. condom, diaphragm) with spermicide

        Note-Significant medical illness is any illness requiring continued care, i.e. chronic
        medication. Examples include hypertension, diabetes, and systemic lupus erythematosis.
        Subjects with seasonal allergies or occasional urinary tract infections will be included.

        Patients with Bulimia Nervosa:

          -  Same as controls