NCT00398619

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Nov 2006

Shorter than P25 for phase_1

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2006

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

November 10, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 14, 2006

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2007

Completed
Last Updated

January 23, 2012

Status Verified

January 1, 2012

Enrollment Period

4 months

First QC Date

November 10, 2006

Last Update Submit

January 20, 2012

Conditions

Insulin ResistanceObesity

Outcome Measures

Primary Outcomes (3)

  • 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

Interventions

INCB13739DRUG

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male and female subjects between 18 years and 65 years of age.
  • BMI between 30 and 42 kg/m2, inclusive.
  • FPG \<126 mg/dL

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Unknown Facility

Beverly Hills, California, 90211, United States

Location

Unknown Facility

Chula Vista, California, 91911, United States

Location

MeSH Terms

Conditions

Insulin ResistanceObesity

Interventions

INCB 13739

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • William V Williams, MD

    Incyte Corporation

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 10, 2006

First Posted

November 14, 2006

Study Start

November 1, 2006

Primary Completion

March 1, 2007

Study Completion

March 1, 2007

Last Updated

January 23, 2012

Record last verified: 2012-01

Locations

US(2)