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临床试验/jRCT2080221755
jRCT2080221755未知1 期

A Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of LY110140 in Healthy Japanese Male Subjects

Eli Lilly Japan K.K.0 个研究点开始时间: 待定
适应症

试验速览

阶段
1 期

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
No limit 至 No limit(—)
性别
Male

入选标准

  • •[Inclusion Criteria]
  • •Overtly healthy Japanese males (as determined by medical history and physical examination) who agree to use a reliable method of birth control during the study and for 3 months following the last dose of the investigational product.
  • •Have a body mass index (BMI) of 18.5 to 29.9kg/m^2, inclusive, at the time of screening.
  • •Have given written informed consent approved by Lilly and the ethical review board (ERB) governing the study site.

排除标准

  • •[Exclusion Criteria]
  • •Poor metabolizers of enzyme Cytochrome P450 2D6 (CYP2D6) (assessed at screening).
  • •Have an abnormality in the 12-lead Electrocardiogram (ECG) at screening that, in the opinion of the investigator, increases the risks associated with participating in the study such as, a Bazett's corrected QT(QTcB) intercal >450 millisecounds (msec).
  • •Have any lifetime history of a suicide attempt, or have suicidal ideation or, any suicidal behavior within the last month, or who are at significant risk to commit suicide, as judged by the investigator using the Columbia Suicide Severity Rating Scale (C-SSRS).
  • •Are unsuitable (in the opinion of the investigator or sponsor) for inclusion in the study.

研究者

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