Insulin Resistance, Obesity
Conditions
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.
Interventions
DRUGINCB13739
Sponsors
Incyte Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Outcome results
None listed