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Phase 2a Obesity Study of Oral Doses of Oleoyl-Estrone (MP-101)
This study is ongoing, but not recruiting participants.
First Received: March 16, 2007   No Changes Posted
Sponsor: Manhattan Pharmaceuticals
Information provided by: Manhattan Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00449202
  Purpose

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.


Condition Intervention Phase
Obesity
Drug: oleoyl-estrone (MP 101)
Phase II

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

Resource links provided by NLM:


Further study details as provided by Manhattan Pharmaceuticals:

Primary Outcome Measures:
  • To evaluate the safety and tolerability

Secondary Outcome Measures:
  • To evaluate the preliminary efficacy

Estimated Enrollment: 100
Study Start Date: June 2006
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00449202

Locations
United States, Louisiana
Pennington Biomedical Research
Baton Rouge, Louisiana, United States, 70808
United States, Utah
Jean Brown Research
Salt Lake City, Utah, United States, 84124
Switzerland
Swiss Pharma Contract
Basel, Switzerland
Sponsors and Collaborators
Manhattan Pharmaceuticals
  More Information

No publications provided

Study ID Numbers: MAN-OE-OS-03
Study First Received: March 16, 2007
Last Updated: March 16, 2007
ClinicalTrials.gov Identifier: NCT00449202     History of Changes
Health Authority: United States: Food and Drug Administration;   Switzerland: Swissmedic

Additional relevant MeSH terms:
Oleoyl-estrone
Obesity
Estrogens
Contraceptive Agents
Estropipate
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Overweight
Reproductive Control Agents
Hormones
Pharmacologic Actions
Body Weight
Anti-Obesity Agents
Signs and Symptoms
Therapeutic Uses
Nutrition Disorders
Overnutrition
Central Nervous System Agents
Estrone

ClinicalTrials.gov processed this record on February 08, 2010