A Study of the Effect of INCB013739 on Cortisone Reducing Enzyme Activity in Obese People Predisposed to Diabetes
Sponsor
Incyte Corporation (Industry)
Overall Status
Completed
CT.gov ID
NCT00398619
Collaborator
(none)
2
3.9
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
Detailed Description
"Proprietary Information: Exploratory (Non-Confirmatory) Trial".
Study Design
Study Type:
Interventional
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.
Study Start Date
:
Nov 1, 2006
Actual Primary Completion Date
:
Mar 1, 2007
Actual Study Completion Date
:
Mar 1, 2007
Outcome Measures
Primary Outcome Measures
- Assessment of pharmacokinetics of INCB013739 through analysis of blood samples. [Serial collections at each visit]
- Evaluation of change in cortisol laboratory values [Serial collections at each visit]
- Assessment of ECGs, laboratory results and physical exams for adverse events [Measured from baseline through study completion]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Beverly Hills | California | United States | 90211 | |
| 2 | Chula Vista | California | United States | 91911 |
Sponsors and Collaborators
- Incyte Corporation
Investigators
- Study Director: William V Williams, MD, Incyte Corporation
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00398619
Other Study ID Numbers:
- INCB13739-103
First Posted:
Nov 14, 2006
Last Update Posted:
Jan 23, 2012
Last Verified:
Jan 1, 2012
Additional relevant MeSH terms: