Back to resultsA Study of the Effect of INCB013739 on Cortisone Reducing Enzyme Activity in Obese People Predisposed to Diabetes
Primary Purpose
Insulin Resistance, Obesity
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
INCB13739
Sponsored by
About this trial
This is an interventional treatment trial for Insulin Resistance
Eligibility 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.
Sites / Locations
Outcomes
Primary Outcome Measures
Assessment of pharmacokinetics of INCB013739 through analysis of blood samples.
Evaluation of change in cortisol laboratory values
Assessment of ECGs, laboratory results and physical exams for adverse events
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00398619
Brief Title
A Study of the Effect of INCB013739 on Cortisone Reducing Enzyme Activity in Obese People Predisposed to Diabetes
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.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
November 2006 (undefined)
Primary Completion Date
March 2007 (Actual)
Study Completion Date
March 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Incyte Corporation
4. Oversight
5. Study Description
Brief Summary
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.
Detailed Description
"Proprietary Information: Exploratory (Non-Confirmatory) Trial".
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insulin Resistance, Obesity
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
INCB13739
Primary Outcome Measure Information:
Title
Assessment of pharmacokinetics of INCB013739 through analysis of blood samples.
Time Frame
Serial collections at each visit
Title
Evaluation of change in cortisol laboratory values
Time Frame
Serial collections at each visit
Title
Assessment of ECGs, laboratory results and physical exams for adverse events
Time Frame
Measured from baseline through study completion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William V Williams, MD
Organizational Affiliation
Incyte Corporation
Official's Role
Study Director
Facility Information:
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
City
Chula Vista
State/Province
California
ZIP/Postal Code
91911
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Study of the Effect of INCB013739 on Cortisone Reducing Enzyme Activity in Obese People Predisposed to Diabetes
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