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

NCT00600743 | Terminated Phase 2 Results

• 1 other identifier: 07-101
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Bulimia

Keywords

Eating; Food Intake; Appetite

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Fullness Rating

  25-30 min after taking drug

• Sickness Report

  25-30 min after drug or placebo

Study Arms (8)

1 'Instructions to eat normally'

PLACEBO COMPARATOR

'Instructions to eat normally' Placebo 1 mg dose

Behavioral: Instructions to eat normally; Drug: Placebo

2 'Instructions to eat normally'

ACTIVE COMPARATOR

'Instructions to eat normally' drug 1 mg dose 'GSKI181771X (CCK-1R agonist)'

Drug: GSKI181771X (CCK-1R agonist); Behavioral: Instructions to eat normally

3 'Instructions to eat normally'

PLACEBO COMPARATOR

'Instructions to eat normally' 2 mg placebo

Behavioral: Instructions to eat normally; Drug: Placebo

4 'Instructions to eat normally'

ACTIVE COMPARATOR

'Instructions to eat normally' 2 mg drug 'GSKI181771X (CCK-1R agonist)'

Drug: GSKI181771X (CCK-1R agonist); Behavioral: Instructions to eat normally

5 'Instructions to eat normally'

PLACEBO COMPARATOR

'Instructions to eat normally' 4 mg placebo

Behavioral: Instructions to eat normally; Drug: Placebo

6 'Instructions to eat normally'

ACTIVE COMPARATOR

'Instructions to eat normally' 4 mg drug 'GSKI181771X (CCK-1R agonist)'

Drug: GSKI181771X (CCK-1R agonist); Behavioral: Instructions to eat normally

7 Instructions to binge eat

PLACEBO COMPARATOR

Instructions to binge eat 4 mg placebo

Behavioral: Instructions to binge eat; Drug: Placebo

8 Instructions to binge eat

ACTIVE COMPARATOR

Instructions to binge eat 4 mg drug 'GSKI181771X (CCK-1R agonist)'

Drug: GSKI181771X (CCK-1R agonist); Behavioral: Instructions to binge eat

Interventions

GSKI181771X (CCK-1R agonist) DRUG

Drug one trial vs placebo

Also known as: GSKI181771X

2 'Instructions to eat normally'; 4 'Instructions to eat normally'; 6 'Instructions to eat normally'; 8 Instructions to binge eat

Instructions to binge eat BEHAVIORAL

Subjects will be instructed to binge eat and will also be given either drug or placebo

7 Instructions to binge eat; 8 Instructions to binge eat

Instructions to eat normally BEHAVIORAL

Subjects will be instructed to eat normally and will also be given either drug or placebo

1 'Instructions to eat normally'; 2 'Instructions to eat normally'; 3 'Instructions to eat normally'; 4 'Instructions to eat normally'; 5 'Instructions to eat normally'; 6 'Instructions to eat normally'

Placebo DRUG

Drug one trial vs placebo

1 'Instructions to eat normally'; 3 'Instructions to eat normally'; 5 'Instructions to eat normally'; 7 Instructions to binge eat

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Normal Controls:
• No current or past psychiatric illness
• No history of binge eating or vomiting
• % ideal weight
• Of non-childbearing potential (i.e. physiologically incapable of becoming pregnant or surgically sterile)
• 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

You may not qualify if:

• 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:

Sponsors & Collaborators

• St. Luke's-Roosevelt Hospital Center: lead
• GlaxoSmithKline: collaborator

Study Sites (1)

St. Luke's/Roosevelt Hospital

New York, New York, 10025, United States

Location

Related Links

• studies

MeSH Terms

Conditions

Bulimia

Condition Hierarchy (Ancestors)

Hyperphagia; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

No adverse events - Some subjects reported a "sick" feeling that was significantly different between drug and control, in the condition where they were instructed to binge eat. This is a subtle feeling without any other symptoms. It is not adverse.

Results Point of Contact

• Title: Harry R. Kissileff
• Organization: St. Luke's/Roosevelt Hospital

hrk2@columbia.edu

212-523-4200

Study Officials

• Harry R. Kissileff, Ph.D.

  St. Luke's-Roosevelt Hospital Center

  PRINCIPAL INVESTIGATOR

• Jeanine Albu, MD

  St. Luke's-Roosevelt Hospital Center

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2008
• First Posted: January 25, 2008
• Study Start: January 1, 2008
• Primary Completion: February 1, 2009
• Study Completion: February 1, 2009
• Last Updated: April 28, 2017
• Results First Posted: April 28, 2017

Record last verified: 2017-04

Locations

US (1)