NL-OMON51743已完成不适用
A single-center, open-label study to evaluate the distribution, metabolism, and excretion (DME) and pharmacokinetics of MIJ821 following a single intravenous (i.v.) infusion of [14C]MIJ821 in healthy male participants. - Distribution, metabolism, and excretion study with [14C]MIJ821
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- ovartis
- 入组人数
- 6
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. Signed informed consent must be obtained prior to participation in the study.
- •2. Healthy males, aged 18 to 55 years (inclusive) and in good health as
- •determined by past and current medical history, physical and neurological
- •examination, vital signs, electrocardiogram, and laboratory tests at screening
- •and baseline (whenever applicable).
- •3. At screening and at baseline (Day -1), vital signs after 5 minutes in supine
- •position must be within the ranges defined in protocol inclusion
- •4. Participants must weigh at least 60 kg and should not exceed 90 kg to
- •participate in the study and must have a body mass index (BMI)
- •within the range of 18.0 to 29.9 kg/m² (inclusive) at screening.
- •5. NM or IM for CYP2D6.
- •6. Participants must be able to communicate well with the Investigator and to
- •comply with the requirements of the entire study, including adhering to study
- •restrictions and visit schedule.
- •See protocol for complete details of inclusion criteria.
排除标准
- •1. Recent history (<3 months) prior to screening of nicotine product use or a
- •urine cotinine level >500 ng/mL at Screening or Baseline.
- •2. Positive blood alcohol concentration or drug test at Screening or Baseline.
- •3. Absence of regular defecation pattern (participants with an average
- •defecation frequency of less than once per 2 days or chronic diarrhea).
- •4. Any surgical or medical condition that might significantly alter the (A)DME
- •of drugs, or that may jeopardize the participant in case of
- •participation in the study.
- •5. Exposure to radiation at a level of up to 1.0 mSv over the past year, or up
- •to 3.0 mSv over the past 3 years. (e.g., due to systemic
- •administration of radioactive substances, or to external irradiation [e.g., by
- •X-rays] for diagnostic, therapeutic, job-related, or research
- •Further criteria apply, see protocol.
研究者
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