Phase 2a Obesity Study of Oral Doses of Oleoyl-Estrone (MP-101)
Status unconfirmed · Phase 2
Conditions studied: Obesity
In brief
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.
Key facts
- Study ID
- NCT00449202
- Run by
- Manhattan Pharmaceuticals
- People needed
- 100
- Starts
- 2006-06-01
- Last updated by the study team
- 2007-03-20
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Pennington Biomedical Research — Baton Rouge, Louisiana, United States
- Jean Brown Research — Salt Lake City, Utah, United States
- Swiss Pharma Contract — Basel, Switzerland
Full record on ClinicalTrials.gov
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