Phase 2a Obesity Study of Oral Doses of Oleoyl-Estrone (MP-101)
This trial is active, not recruiting.
|Treatment||oleoyl-estrone (mp 101)|
|Start date||June 2006|
|Trial size||100 participants|
|Trial identifier||NCT00449202, MAN-OE-OS-03|
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.
|United States||No locations recruiting|
|Other Countries||No locations recruiting|
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
To evaluate the safety and tolerability
To evaluate the preliminary efficacy
Male or female participants from 18 years up to 65 years old.
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
|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|
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