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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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Glucose Metabolism Disorders
Hyperinsulinism
Metabolic Diseases

ClinicalTrials.gov processed this record on November 20, 2014