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临床试验/NL-OMON50544
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.

研究者

发起方
Starton Therapeutics

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