NCT00449202UnknownPhase 2
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
Manhattan Pharmaceuticals3 sites in 2 countries100 target enrollmentStarted: June 1, 2006Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Sponsor
- Manhattan Pharmaceuticals
- Enrollment
- 100
- Locations
- 3
- Primary Endpoint
- To evaluate the safety and tolerability
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
To evaluate the safety and tolerability
Secondary Outcomes
- To evaluate the preliminary efficacy
Investigators
Study Sites (3)
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