NCT00828724已完成1 期
An Open Label, Single Dose, Cross-over Study to Assess the Pharmacokinetic Properties of Lorcaserin in the Fed and Fasted State
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Eisai Inc.
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- To evaluate the pharmacokinetic properties of a single oral dose of lorcaserin in the fed versus fasted state
研究概览
简要总结
The purpose of this study is to evaluate the PK properties in fed and fasted men and women.
研究设计
- 研究类型
- Interventional
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males or females aged between 18 and 65 years (inclusive)
- •Able to give signed informed consent
- •BMI 27-45 kg/m2, inclusive
- •Eligible male and female subjects must agree not to participate in a conception process.
- •Considered to be in stable health in the opinion of the Investigator.
排除标准
- •Prior participation in any study of lorcaserin.
- •Clinically significant new illness in the 1 month before screening
- •Not suitable to participate in the study in the opinion of the Investigator including an existing physical or mental condition that prevents compliance with the protocol
- •History of any of the following cardiovascular conditions:
- •Myocardial infarction (diagnosed by cardiac enzyme[s] and/or diagnostic ECG), CVA, TIA or RIND within 6 months of screening;
- •Cardiac arrhythmia requiring medical or surgical treatment within 6 months of screening
- •Unstable angina
- •History of pulmonary artery hypertension
- •Positive result of HIV, hepatitis B or hepatitis C screens
- •Malignancy within 2 years of the screening visit (except basal cell or squamous cell carcinoma with clean surgical margins)
- •Initiation of a new prescription medication within 1 month prior to screening.
- •Recent history (within 2 years prior to the screening visit) of alcohol or drug/solvent abuse or a positive screen for drugs of abuse at screening.
- •Participated in any clinical study with an investigational drug, biologic, or device within 1 month prior to screening
- •Use of SSRIs,SNRIs, and other medications must meet the washout period.
研究组 & 干预措施
Lorcaserin 10mg
Experimental
干预措施: Lorcaserin 10mg (Drug)
结局指标
主要结局
To evaluate the pharmacokinetic properties of a single oral dose of lorcaserin in the fed versus fasted state
次要结局
未报告次要终点
研究者
研究点 (1)
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