Phase 2a Obesity Study of Oral Doses of Oleoyl-Estrone (MP-101)
Information source: Manhattan Pharmaceuticals
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Obesity
Intervention: oleoyl-estrone (MP 101) (Drug)
Phase: Phase 2
Status: Active, not recruiting
Sponsored by: Manhattan Pharmaceuticals
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.
Clinical Details
Official title: A Phase 2a Randomized, Double-Blind, Placebo Controlled, Parallel Group, Safety and Efficacy Study of Two 14 Day Cycles of Oral Doses of Oleoyl-Estrone (MP-101) in Obese Adult Subjects
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: To evaluate the safety and tolerability
Secondary outcome: To evaluate the preliminary efficacy
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
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
Locations and Contacts
Swiss Pharma Contract, Basel, Switzerland
Pennington Biomedical Research, Baton Rouge, Louisiana 70808, United States
Jean Brown Research, Salt Lake City, Utah 84124, United States
Additional Information
Starting date: June 2006
Last updated: March 16, 2007
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