NL-OMON50544已完成不适用
An Open-label, Randomized, Crossover, Single Ascending Dose Pharmacokinetic Study of Continuous Subcutaneous Infusion of Lenalidomide Compared with Revlimid® Oral Capsules in Healthy Adult Male Subjects - Lenalidomide single ascending dose study in healthy male subjects
Starton Therapeutics0 个研究点目标入组 16 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 16
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 64（—）
入选标准
- •1. Gender : Male.
- •2. Age : 18 years to 55 years, inclusive, at screening.
- •3. Body mass index (BMI) : 18.0 kg/m2 to 32.0 kg/m2, inclusive at screening.
- •4. Weight : 50 kg to 110 kg, inclusive, at screening.
- •5. Status : Healthy subjects.
- •6. Creatinine clearance >61 mL/min (by Chronic Kidney Disease Epidemiology
- •Collaboration).
排除标准
- •1. Employee of PRA or the sponsor.
- •2. History of relevant drug and/or food allergies.
- •3. History of alcohol abuse or drug addiction (including soft drugs like
- •cannabis products).
- •4. Positive drug and alcohol screen (opiates, methadone, cocaine, amphetamines
- •[including ecstasy], cannabinoids, barbiturates, benzodiazepines, tricyclic
- •antidepressants, and alcohol) at screening and admission to the clinical
- •research center.
- •5. Average intake of more than 24 units of alcohol per week (1 unit of alcohol
- •equals approximately 250 mL of beer, 100 mL of wine, or 35 mL of spirits).
- •6. Positive screen for hepatitis B surface antigen (HBsAg), anti-hepatitis C
- •virus (HCV) antibodies, or anti-human immunodeficiency virus (HIV) 1 and 2
- •antibodies.
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