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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:
Information provided by:
Incyte Corporation
ClinicalTrials.gov Identifier:
NCT00398619
First received: November 10, 2006
Last updated: January 20, 2012
Last verified: January 2012
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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.

Resource links provided by NLM:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]
  • Evaluation of change in cortisol laboratory values [ Time Frame: Serial collections at each visit ] [ Designated as safety issue: No ]
  • Assessment of ECGs, laboratory results and physical exams for adverse events [ Time Frame: Measured from baseline through study completion ] [ Designated as safety issue: Yes ]

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

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

Responsible Party: William Williams, M.D.
ClinicalTrials.gov Identifier: NCT00398619     History of Changes
Other Study ID Numbers: INCB13739-103
Study First Received: November 10, 2006
Last Updated: January 20, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Insulin Resistance
Obesity
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
 Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on June 18, 2013