NCT02169804已完成1 期
An Open-Label Study to Evaluate the Effect of Age Upon the Pharmacokinetics of Androxal
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 主要终点
- Pharmacokinetics - The Cmax will be calculated.
研究概览
简要总结
• To determine and compare the pharmacokinetics (PK) of 3 doses of 25 mg Androxal in elderly healthy adult male subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Speak, read, and understand English or Spanish and is willing and able to provide written informed consent on an IRB-approved form prior to the initiation of any study procedures;
- •Male; age <60 or ≥70 years of age
- •No significant abnormal findings at the screening physical examination as evaluated by the Investigator;
- •Normal laboratory values (or abnormal but not clinically significant) at screening as determined by the Investigator;
- •Subject is willing to remain in the clinic for the screening visit and one overnight treatment visit after the 3rd dose of Androxal (approximately 36 hours for the treatment visit)
- •Must be able to swallow gelatin capsules
排除标准
- •Known hypersensitivity to Clomid;
- •Abnormal screening visit vital signs or clinical laboratory evaluation considered clinically significant by the Investigator;
- •A hematocrit >54% or a hemoglobin >17 g/dL.
- •Subject with a significant organ abnormality or disease as determined by the Investigator;
- •Any medical condition that would interfere with the study as determined by the Investigator;
- •Participation in a clinical trial with investigational medication within 30 days prior to study medication administration;
- •An acute illness within 5 days of study medication administration;
- •Positive urine drug screen at the screening visit;
- •Known history of HIV and/or Hepatitis B or C
- •Tobacco (nicotine products) use in the 3 months prior to the study;
- •A mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study and/or evidence of an uncooperative attitude, as determined by the Investigator;
- •History of venous thromboembolic disease (e.g. deep vein thrombosis or pulmonary embolism);
- •History of myocardial infarction, unstable angina, symptomatic heart failure, ventricular dysrhythmia, or known history of QTc interval prolongation;
- •An employee or family member of an employee of the study site or the Sponsor;
- •Previous participation in a clinical study of Androxal.
研究组 & 干预措施
70 years or older
Experimental
Non-smoking healthy adult males >or equal to 70 years of age.
干预措施: Androxal 25 mg (Drug)
Under 60 years of age
Experimental
Non-smoking healthy adult males<60 years of age.
干预措施: Androxal 25 mg (Drug)
结局指标
主要结局
Pharmacokinetics - The Cmax will be calculated.
时间窗: 4 days
Pharmacokinetics - The Tmax will be calculated.
时间窗: 4 days
Pharmacokinetics - The AUC0-24 will be calculated.
时间窗: 4 days
Pharmacokinetics - the AUC0-∞ will be calculated.
时间窗: 4 days
Pharmacokinetics - The t½ will be calculated.
时间窗: 4 days
次要结局
- Safety - Incidence of adverse events(4 days)
- Safety -Mean change from baseline in laboratory values(4 days)
- Safety - Mean change from baseline in vital signs(4 days)
研究者
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