Effect of a CCK-1R Agonist on Food Intake in Humans

• Status: Terminated
• Trial end date: 2009-02-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: St. Luke's-Roosevelt Hospital Center
• Collaborator: GlaxoSmithKline

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