A Study of the Effect of INCB013739 on Cortisone Reducing Enzyme Activity in Obese People Predisposed to Diabetes

This study has been completed.

First Received: November 10, 2006 Last Updated: January 8, 2009 History of Changes

Sponsored by:	Incyte Corporation
Information provided by:	Incyte Corporation
ClinicalTrials.gov Identifier:	NCT00398619

Purpose

The purpose of this study is to determine whether the investigational drug INCB013739 has an effect on systemic and adipose tissue 11-HSD1 activity in obese, insulin resistant subjects.

Condition	Intervention	Phase
Insulin Resistance Obesity	Drug: INCB13739	Phase I

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Double-Blind, Placebo Controlled Pharmacodynamic Study of the Effect of INCB013739 on Systemic and Adipose Tissue 11βHSD1 Activity in Obese, Insulin Resistant Subjects.

Resource links provided by NLM:

MedlinePlus related topics: Obesity

U.S. FDA Resources

Further study details as provided by Incyte Corporation:

Primary Outcome Measures:

Pharmacodynamic measurements

Secondary Outcome Measures:

Pharmacokinetic endpoints
Safety and tolerability

Study Start Date:	November 2006
Study Completion Date:	March 2007

Detailed Description:

"Proprietary Information: Exploratory (Non-Confirmatory) Trial".

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Male and female subjects between 18 years and 65 years of age.
BMI between 30 and 42 kg/m2, inclusive.
FPG <126 mg/dL

Exclusion Criteria:

Meet criteria for diagnosis of diabetes mellitus at the screening evaluation, female subjects with a history of gestational diabetes are permitted.
Are receiving oral antidiabetic agents within the 3 months prior to screening.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00398619

Locations

United States, California

Beverly Hills, California, United States, 90211

Chula Vista, California, United States, 91911

Sponsors and Collaborators

Incyte Corporation

Investigators

Study Director:

William V Williams, MD

Incyte Corporation

More Information

No publications provided

Study ID Numbers:	INCB13739-103
Study First Received:	November 10, 2006
Last Updated:	January 8, 2009
ClinicalTrials.gov Identifier:	NCT00398619 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Obesity
Metabolic Diseases
Cortisone
Diabetes Mellitus
Overweight
Insulin
Body Weight
Hyperinsulinism

Signs and Symptoms
Cortisone acetate
Nutrition Disorders
Overnutrition
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Disorder

Additional relevant MeSH terms:

Body Weight
Signs and Symptoms
Hyperinsulinism
Obesity
Metabolic Diseases

Nutrition Disorders
Overweight
Overnutrition
Insulin Resistance
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on September 11, 2009