Status:
UNKNOWN
Phase 2a Obesity Study of Oral Doses of Oleoyl-Estrone (MP-101)
Lead Sponsor:
Manhattan Pharmaceuticals
Conditions:
Obesity
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate the safety, preliminary efficacy, and pharmacokinetics of two 14-day cycles of escalating oral doses of MP 101 in 100 obese adult subjects.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00449202
Start Date
June 1 2006
Last Update
March 20 2007
Active Locations (3)
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1
Pennington Biomedical Research
Baton Rouge, Louisiana, United States, 70808
2
Jean Brown Research
Salt Lake City, Utah, United States, 84124
3
Swiss Pharma Contract
Basel, Switzerland