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

Obesity Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00398619
• Other study ID #: INCB13739-103
• Status: Completed
• Phase: Phase 1
• First received: November 10, 2006
• Last updated: January 20, 2012
• Start date: November 2006
• Est. completion date: March 2007

Study information

• Verified date: January 2012
• Source: Incyte Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

"Proprietary Information: Exploratory (Non-Confirmatory) Trial".

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: March 2007
• Est. primary completion date: March 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Insulin Resistance
• Obesity

Intervention

Drug:
• INCB13739

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Incyte Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of pharmacokinetics of INCB013739 through analysis of blood samples.		Serial collections at each visit	No
Primary	Evaluation of change in cortisol laboratory values		Serial collections at each visit	No
Primary	Assessment of ECGs, laboratory results and physical exams for adverse events		Measured from baseline through study completion	Yes