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Completed

NCT Number: NCT00398619

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

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.

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Key information

Conditions

Insulin Resistance Body Weight Glucose Metabolism Disorders Hyperinsulinism Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Beverly Hills, California, United States

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

INCB13739

Drug

Primary outcomes

  1. Assessment of pharmacokinetics of INCB013739 through analysis of blood samples.

    Time frame: Serial collections at each visit

  2. Evaluation of change in cortisol laboratory values

    Time frame: Serial collections at each visit

  3. Assessment of ECGs, laboratory results and physical exams for adverse events

    Time frame: Measured from baseline through study completion

Sponsors and collaborators

Lead sponsor

Incyte Corporation

Industry

Registry information

Official study 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.

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Nov 14, 2006
Registry last updated
Jan 23, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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