NL-OMON51599已完成不适用
A phase 1, open-label study to assess the absorption, metabolism, and excretion, including the mass balance, of a single oral dose of [14C]-etrumadenant in healthy male subjects - AME study with etrumadenant
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 8
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. Sex at birth : male.
- •2. Age : 18 to 55 years, inclusive, at screening.
- •3. Body mass index (BMI) : 18.0 to 32.0 kg/m2, inclusive, at screening.
- •4. Body weight : >=50 kg, inclusive, at screening.
- •5. Status : healthy subjects.
- •Further criteria apply, see protocol.
排除标准
- •1. Employee of PRA or the Sponsor.
- •2. History of relevant drug and/or food allergies.
- •3. Using tobacco products within 2 months prior to drug administration.
- •4. History of alcohol abuse or drug addiction (including soft drugs like
- •cannabis products) over the past 2 years.
- •5. Positive drug and alcohol screen (opiates, methadone, cocaine, amphetamines
- •[including ecstasy], cannabinoids, barbiturates, benzodiazepines, tricyclic
- •antidepressants, and alcohol) at screening or (first) admission to the clinical
- •research center.
- •Further criteria apply, see protocol.
研究者
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