A Study of the Effect of INCB013739 on Cortisone Reducing... | NCT00398619

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

NCT00398619

Sponsor

Incyte Corporation

Status

Completed

Last Update Posted

Jan 23, 2012Estimated

Enrollment

Not provided

Phase

Phase 1

Conditions

Insulin Resistance
Obesity

Interventions

INCB13739

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2006

Primary Completion Date

Mar 2007Actual

Completion Date

Mar 2007Actual

First Submitted Date

Nov 10, 2006

First Submission Date that Met QC Criteria

Nov 10, 2006

First Posted Date

Nov 14, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 20, 2012

Last Update Posted Date

Jan 23, 2012Estimated

Description Module

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".

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Name	Type	Description	Arm Group Labels	Other Names
INCB13739	Drug

Outcomes Module

Primary Outcomes

Measure	Description	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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
William V Williams, MD	Incyte Corporation	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
		Beverly Hills	California	90211	United States

Condition Browse Module

MeSH Terms

ID	Term
D007333	Insulin Resistance
D009765	Obesity

Ancestor Terms

ID	Term
D006946	Hyperinsulinism
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C552933	INCB 13739

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided