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

Bulimia Clinical Trial

— GSK  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00600743
• Other study ID #: 07-101
• Status: Terminated
• Phase: Phase 2
• First received: January 14, 2008
• Last updated: April 26, 2017
• Start date: January 2008
• Est. completion date: February 2009

Study information

• Verified date: April 2017
• Source: St. Luke's-Roosevelt Hospital Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

This study tests the hypothesis that an oral CCK antagonist GSKI181771X will reduce the size of a binge meal. It was intended to study the effects of increasing doses on antagonist on normal individuals to find an effective dose in a non-binge meal before moving to a binge meal. Once the effects of the antagonist on a binge meal were found, the compound would be used on patients with bulimia nervosa. However, the product expired and more was not available before the patients were tested. Data are presented for the normal participants who were instructed to eat normally, followed by a group that was instructed to binge eat. Comparisons were made between groups with different instructions and between binge and normal meals.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 40
• Est. completion date: February 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Bulimia

Intervention

Drug:
• GSKI181771X (CCK-1R agonist)
Drug one trial vs placebo

Behavioral:
• Instructions to binge eat
Subjects will be instructed to binge eat and will also be given either drug or placebo
• Instructions to eat normally
Subjects will be instructed to eat normally and will also be given either drug or placebo

Drug:
• Placebo
Drug one trial vs placebo

Locations

Country	Name	City	State
United States	St. Luke's/Roosevelt Hospital	New York	New York

Sponsors (2)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Food Intake for 4 mg Dose of CCK Agonist vs Placebo Meal Conditions	Food Intake at 25-30 min after having drug or placebo under normal and binge eating instructions	25-30 min after taking drug
Secondary	Fullness Rating	rating of "How full do you feel" by marking the feeling on a 150 mm line anchored at one end from 0 (not at all) to 150 (most imaginable).	25-30 min after taking drug
Secondary	Sickness Report	Response to question "How sick do you feel" measured on a 150 mm line anchored by none at all (0 mm left end) and extremely (150 mm right end)	25-30 min after drug or placebo

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