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

Phase 1

Completed

• Conditions: Insulin Resistance; Obesity

• Registration Number: NCT00398619
• Lead Sponsor: Incyte Corporation

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".

Study Timeline

• Study Start: 2006-11
• Study First Submitted: 2006-11-10
• Study First Submitted QC: 2006-11-10
• Study First Posted: 2006-11-14
• Primary Completion: 2007-03
• Study Completion: 2007-03
• Status Verified: 2012-01
• Last Update Submitted: 2012-01-20
• Last Update Posted: 2012-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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