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

This study has been completed.

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

MedlinePlus related topics: Obesity

Drug Information available for: Insulin

U.S. FDA Resources

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.

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

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

Study placed in the following topic categories:

Obesity
Metabolic Diseases
Diabetes Mellitus
Overweight
Insulin
Body Weight
Hyperinsulinism

Signs and Symptoms
Nutrition Disorders
Overnutrition
Insulin Resistance
Glucose Metabolism Disorders
Metabolic disorder

ClinicalTrials.gov processed this record on January 16, 2009