Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:56 AM
Ignite Modification Date:
2025-12-25 @ 3:56 AM
NCT ID:
NCT00449202
Eligibility Criteria:
Inclusion Criteria:
* Be a male or female between the ages of 18 and 65 years, inclusive
* Female subjects must be either surgically sterile or at least 2 years postmenopausal
* Have a BMI of 27 - 38.9, inclusive
* Have a stable weight for the past 30 days per subject report
* Be otherwise healthy and have an acceptable medical history
* Have negative urinalysis test results for drugs of abuse and alcohol
* Have the ability to understand the requirements of the study, have provided written informed consent and agree to abide by the study restrictions
* Exhibit stable behavior patterns with regard to smoking and exercise
* Subject who has at least one factor of the metabolic syndrome
Exclusion Criteria:
* Be pregnant or nursing
* Have taken exclusionary medication in the past 30 days
* Have any clinically significant abnormal laboratory test as determined by the investigator
* Have a clinically significant illness during the 30 days before enrollment
* Have a history of testing positive for Hepatitis B virus, Hepatitis C virus, or HIV
* Have a confirmed diagnosis or history of cancer, with the exception of nonmelanoma skin cancer
* Have a previous diagnosis of diabetes
* Be otherwise unsuitable for the study, in the opinion of the investigator
* Have an allergy to safflower seeds or its byproducts (e.g., safflower oil)
* Have any postmenopausal bleeding within the last 6 months
* Have been involved in a formal or informal (self-imposed) diet regimen within the last 30 days
* Currently working night shifts
* Have a history of known multiple miscarriages
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00449202
Study Brief:
Protocol Section:
NCT00449202