Status:
UNKNOWN
Phase 2a Randomized, Double-Blind Study of Oleoyl-Estrone in Male Morbidly Obese Adults
Lead Sponsor:
Manhattan Pharmaceuticals
Conditions:
Obesity
Eligibility:
MALE
18-60 years
Phase:
PHASE2
Brief Summary
Multi-center, multiple-dose, randomized, double-blind, three-arm, placebo-controlled study of fixed-dose repeated oral dosing for 30 days of 10 mg and 30 mg MP-101 and placebo in obese subjects.
Eligibility Criteria
Inclusion
- Subject is willing and able to provide signed informed consent.
- Subject is a male and is between 18-60 years of age.
- Subject is obese as defined as a BMI of 40 - 55.
- Subject is reasonably healthy and have a reasonably acceptable medical history
- Subject has a stable weight for the past 30 days per subject report.
- Subject who has at least one factor of the metabolic
- Subject exhibits stable behavior patterns with regard to smoking and exercise
- Subject can read, speak and write the English language and agrees to follow study procedures.
Exclusion
- Subjects who have received any investigational medication within 3 months prior to administration of study drug
- Subjects with confirmed positive results of UDS or Alcohol
- Subjects who are unwilling to return to the clinical research center on specified days during the treatment periods.
- Subjects who have taken exclusionary medication
- Subjects with any clinically significant laboratory abnormality or illness which, in the opinion of the Investigator, would contraindicate study participation
- Subjects who have a history of testing positive for Hepatitis B virus, Hepatitis C virus, or HIV.
- Subject has been involved in a formal or informal (self-imposed) diet regimen within the last 30 days.
- Subject has a confirmed diagnosis or history of cancer, with the exception of nonmelanoma skin cancer.
- Subject is otherwise unsuitable for the study, in the opinion of the investigator.
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00449254
Start Date
October 1 2006
Last Update
June 5 2007
Active Locations (3)
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1
St. Luke's-Roosevelt Hospital
New York, New York, United States, 10025
2
Research Across America
Dallas, Texas, United States, 75234
3
Jean Brown Research
Salt Lake City, Utah, United States, 84124