NCT00828581已完成1 期
An Open-Label, Single-Dose Study of the Pharmacokinetic Properties of Lorcaserin in Obese or Overweight Elderly Subjects
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 compare the single-dose pharmacokinetic (PK) parameters of lorcaserin in the obese or overweight Elderly (> 65) to those obtained from the obese or overweight Adult (18-65)
研究概览
简要总结
The purpose of this study is to evaluate the PK properties of lorcaserin in obese or overweight elderly subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or females
- •Control (Adult) group: aged between 18 and 65 years (inclusive)
- •Elderly group: aged > 65 years (includes subjects 1 day or more beyond the 65th birthday)
- •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 (i.e. active attempt to become pregnant or to impregnate, egg or sperm donation, in vitro fertilization).
- •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), cerebral vascular accident (CVA), transient ischemic attack (TIA) or reversible ischemic neurologic deficit (RIND) within 6 months of screening
- •Cardiac arrhythmia requiring initiation of new medical or surgical treatment within 6 months of screening (stable medical therapy for > 6 months, pacemakers and/or defibrillators implanted > 6 months prior to screening are acceptable)
- •Unstable angina
- •History of pulmonary artery hypertension
- •Positive result of HIV, hepatitis B or hepatitis C screens
- •Initiation of a new prescription medication within 1 month prior to screening with the following exceptions:
- •Use of SSRIs, SNRIs, and other medications must meet washout period.
- •Participated in any clinical study with an investigational drug, biologic, or device within 1 month prior to screening
研究组 & 干预措施
Lorcaserin
Experimental
干预措施: lorcaserin (Drug)
结局指标
主要结局
To compare the single-dose pharmacokinetic (PK) parameters of lorcaserin in the obese or overweight Elderly (> 65) to those obtained from the obese or overweight Adult (18-65)
次要结局
- To assess the safety and tolerability of a single oral dose of lorcaserin in obese or overweight Elderly (> 65) subjects and obese or overweight Adult (18-65) subjects.
研究者
研究点 (1)
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