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

March 16, 2007 updated by: Manhattan Pharmaceuticals

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

100

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Basel, Switzerland
        • Swiss Pharma Contract
  • United States
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70808
        • Pennington Biomedical Research
    • Utah
      • Salt Lake City, Utah, United States, 84124
        • Jean Brown Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
To evaluate the safety and tolerability

Secondary Outcome Measures

Outcome Measure
To evaluate the preliminary efficacy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Manhattan Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2006

Study Registration Dates

First Submitted

March 16, 2007

First Submitted That Met QC Criteria

March 16, 2007

First Posted (Estimate)

March 20, 2007

Study Record Updates

Last Update Posted (Estimate)

March 20, 2007

Last Update Submitted That Met QC Criteria

March 16, 2007

Last Verified

March 1, 2007

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MAN-OE-OS-03

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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