Phase 2a Obesity Study of Oral Doses of Oleoyl-Estrone (MP-101)

NCT ID: NCT00449202

Last Updated: 2007-03-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-06-30

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.

Conditions

Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

oleoyl-estrone (MP 101)

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Manhattan Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Locations

Pennington Biomedical Research

Baton Rouge, Louisiana, United States

Jean Brown Research

Salt Lake City, Utah, United States

Swiss Pharma Contract

Basel, , Switzerland

Countries

United States; Switzerland

Other Identifiers

MAN-OE-OS-03

Identifier Type: -

Identifier Source: org_study_id