跳至主要内容
临床试验/NL-OMON50412
NL-OMON50412已完成不适用

An open-label study to characterize the absorption, distribution, metabolism and elimination of a single oral dose of 14C-leniolisib in healthy male subjects - Leniolisib ADME Study

Pharming Technologies B.V.0 个研究点目标入组 6 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
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. Male between 18 and 45 years of age (both inclusive) at the screening visit;
  • 2. Subject has Dutch or English as native language
  • 3. Body mass index between 18.5 and 30.0 kg/m2 (both inclusive);
  • 4. Subject is judged to be in good health based on medical history, physical
  • examination, vital sign measurements, and laboratory safety tests performed at
  • the screening visit and prior to administration of the initial dose of study
  • 5. Subject has regular (daily) bowel movements;

排除标准

  • 1. Employee of PRA or the Sponsor;
  • 2. History of known sensitivity or intolerability to leniolisib or to any
  • related compound or excipients in the formulation, or history of significant
  • multiple and/or severe allergies (including latex allergy) or has had an
  • anaphylactic reaction or significant intolerability to prescription or
  • non-prescription drugs or food;
  • 3. The radiation exposure from the previous 3 year period is over 10 mSv for
  • subjects who had been exposed to ionizing radiation above background as a
  • result of their work with radiation as Category A (classified) workers or as a
  • result of research studies they might have been involved in. Clinical
  • (therapeutic or diagnostic) exposure will not be included;
  • 4. An occupation which requires monitoring for radiation exposure, nuclear
  • medicine procedures or excessive x-rays within the past 12 months;
  • 5. History of clinically significant endocrine, gastrointestinal,
  • cardiovascular, haematological, hepatic, immunological, renal, respiratory,
  • neoplastic or genitourinary abnormalities or diseases;

研究者

相似试验