NCT00449254Unknown2 期
A Phase 2a Randomized, Double-Blind, Placebo Controlled, Parallel Group, Safety and Efficacy Study of Oleoyl-Estrone (MP-101) in Male Obese Adults.
适应症
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 24
- 试验地点
- 5
- 主要终点
- To evaluate the safety and tolerability
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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 -
- •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.
排除标准
- •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.
结局指标
主要结局
To evaluate the safety and tolerability
次要结局
- To evaluate the preliminary efficacy
研究者
研究点 (5)
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