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

Phase 2

Terminated

• Conditions: Bulimia
• Interventions: Drug: GSKI181771X (CCK-1R agonist); Behavioral: Instructions to eat normally; Behavioral: Instructions to binge eat; Drug: Placebo

• Registration Number: NCT00600743
• Lead Sponsor: St. Luke's-Roosevelt Hospital Center

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2008-01-14
• Study First Submitted QC: 2008-01-24
• Study First Posted: 2008-01-25
• Primary Completion: 2009-02
• Study Completion: 2009-02
• Results First Submitted: 2011-02-21
• Status Verified: 2017-04
• Results First Submitted QC: 2017-04-26
• Last Update Submitted: 2017-04-26
• Results First Posted: 2017-04-28
• Last Update Posted: 2017-04-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 40

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
2 'Instructions to eat normally'	GSKI181771X (CCK-1R agonist)	'Instructions to eat normally' drug 1 mg dose 'GSKI181771X (CCK-1R agonist)'
1 'Instructions to eat normally'	Instructions to eat normally	'Instructions to eat normally' Placebo 1 mg dose
1 'Instructions to eat normally'	Placebo	'Instructions to eat normally' Placebo 1 mg dose
3 'Instructions to eat normally'	Instructions to eat normally	'Instructions to eat normally' 2 mg placebo
4 'Instructions to eat normally'	GSKI181771X (CCK-1R agonist)	'Instructions to eat normally' 2 mg drug 'GSKI181771X (CCK-1R agonist)'
2 'Instructions to eat normally'	Instructions to eat normally	'Instructions to eat normally' drug 1 mg dose 'GSKI181771X (CCK-1R agonist)'
5 'Instructions to eat normally'	Instructions to eat normally	'Instructions to eat normally' 4 mg placebo
5 'Instructions to eat normally'	Placebo	'Instructions to eat normally' 4 mg placebo
6 'Instructions to eat normally'	GSKI181771X (CCK-1R agonist)	'Instructions to eat normally' 4 mg drug 'GSKI181771X (CCK-1R agonist)'
7 Instructions to binge eat	Instructions to binge eat	Instructions to binge eat 4 mg placebo
6 'Instructions to eat normally'	Instructions to eat normally	'Instructions to eat normally' 4 mg drug 'GSKI181771X (CCK-1R agonist)'
8 Instructions to binge eat	GSKI181771X (CCK-1R agonist)	Instructions to binge eat 4 mg drug 'GSKI181771X (CCK-1R agonist)'
8 Instructions to binge eat	Instructions to binge eat	Instructions to binge eat 4 mg drug 'GSKI181771X (CCK-1R agonist)'
3 'Instructions to eat normally'	Placebo	'Instructions to eat normally' 2 mg placebo
7 Instructions to binge eat	Placebo	Instructions to binge eat 4 mg placebo
4 'Instructions to eat normally'	Instructions to eat normally	'Instructions to eat normally' 2 mg drug 'GSKI181771X (CCK-1R agonist)'

Primary Outcome Measures

Name	Time	Method
Food Intake for 4 mg Dose of CCK Agonist vs Placebo Meal Conditions	25-30 min after taking drug	Food Intake at 25-30 min after having drug or placebo under normal and binge eating instructions

Secondary Outcome Measures

Name	Time	Method
Fullness Rating	25-30 min after taking drug	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).
Sickness Report	25-30 min after drug or placebo	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)

Trial Locations

Locations (1)

St. Luke's/Roosevelt Hospital; 🇺🇸 New York, New York, United States