Insulin ResistancePhase 1NCT00398619
A Study of the Effect of INCB013739 on Cortisone Reducing Enzyme Activity in Obese People Predisposed to Diabetes
A Phase 1 study testing INCB13739 in people with Insulin Resistance and Obesity, run by Incyte Corporation at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Insulin Resistance, Obesity
- What is being tested?
- INCB13739
- How many people
- Not given
- Where
- 2 sitesUnited States
- Study dates
- Nov 2006to Mar 2007
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female subjects between 18 years and 65 years of age.
- BMI between 30 and 42 kg/m2, inclusive.
- FPG <126 mg/dL
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Study site
Beverly Hills, California, 90211
Study site
Chula Vista, California, 91911
About this study
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.
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.
Read the detailed description
"Proprietary Information: Exploratory (Non-Confirmatory) Trial".
- Conditions
- Insulin Resistance, Obesity
- Being tested
- INCB13739
- Medical subject headings
- Insulin Resistance, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INCB13739Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of pharmacokinetics of INCB013739 through analysis of blood samples.
Measured: Serial collections at each visit
Evaluation of change in cortisol laboratory values
Measured: Serial collections at each visit
Assessment of ECGs, laboratory results and physical exams for adverse events
Measured: Measured from baseline through study completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2006 (estimated)
- Study startNov 2006
- Primary completionMar 2007
- Study completionMar 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insulin ResistanceStudies of the same condition, open and under way.
- More trials run by Incyte CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Sponsor and investigators
- Lead sponsor
- Incyte Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- William V Williams, MD, Study director, Incyte Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00398619
- Sponsor's protocol ID
- INCB13739-103
- Status last verified
- Jan 2012
- First submitted
- 10 Nov 2006
- Last updated
- 23 Jan 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00398619
- Acronym / sponsor ID
- INCB13739-103
- Conditions
- Insulin Resistance, Obesity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Incyte CorporationIndustry (pharma, biotech, devices)
- Study start
- Nov 2006
- Primary completion
- Mar 2007 (actual)
- Study completion
- Mar 2007 (actual)
- First posted
- 14 Nov 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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".
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male and female subjects between 18 years and 65 years of age.
- BMI between 30 and 42 kg/m2, inclusive.
- FPG <126 mg/dL
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| INCB13739 | Drug | – |
Primary outcome
Assessment of pharmacokinetics of INCB013739 through analysis of blood samples.
Time frame: Serial collections at each visit
Evaluation of change in cortisol laboratory values
Time frame: Serial collections at each visit
Assessment of ECGs, laboratory results and physical exams for adverse events
Time frame: Measured from baseline through study completion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William V Williams, MD study director
Incyte Corporation
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing INCB13739 in people with Insulin Resistance and Obesity, run by Incyte Corporation at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of pharmacokinetics of INCB013739 through analysis of blood samples. (time frame: Serial collections at each visit). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2012.