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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00398619
First Posted: November 14, 2006
Last Update Posted: January 23, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Incyte Corporation
  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 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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:
  • Assessment of pharmacokinetics of INCB013739 through analysis of blood samples. [ Time Frame: Serial collections at each visit ]
  • Evaluation of change in cortisol laboratory values [ Time Frame: Serial collections at each visit ]
  • Assessment of ECGs, laboratory results and physical exams for adverse events [ Time Frame: Measured from baseline through study completion ]

Study Start Date: November 2006
Study Completion Date: March 2007
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
Detailed Description:
"Proprietary Information: Exploratory (Non-Confirmatory) Trial".
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: William Williams, M.D.
ClinicalTrials.gov Identifier: NCT00398619     History of Changes
Other Study ID Numbers: INCB13739-103
First Submitted: November 10, 2006
First Posted: November 14, 2006
Last Update Posted: January 23, 2012
Last Verified: January 2012

Additional relevant MeSH terms:
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases