NL-OMON50254已完成不适用
A single center, open-label Phase 1 trial to evaluate the mass balance and metabolite profile of a single oral dose of pritelivir. - Mass balance and metabolite profile of pritelivir.
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. Subject has been informed both verbally and in writing about the objectives
- •of the clinical trial, the methods, the anticipated potential risks and the
- •discomfort to which he may be exposed and has given written consent to
- •participation in the trial prior to trial start and any trial-related procedure.
- •2. Male subjects of any ethnic origin aged between 18 and 55 years (inclusive).
- •Assessed as otherwise healthy based on pre-trial examinations including medical
- •history, physical examination, blood pressure, pulse rate, body temperature,
- •ECG assessment, and clinical laboratory results.
- •3. Subjects not planning to father or to donate sperms for in vitro
- •fertilization during three months after dosing of trial medication. Adequate
- •contraception must be used during sexual intercourse with
- •women of childbearing potential to make sure the fathering of a child will be
- •ruled out during the trial and during the three months after dosing of trial
- •medication. Adequate contraception is defined as a
- •combination of a highly effective method of birth control and additional
- •barrier contraception. Highly effective method of birth control is defined as
- •follows: combined (estrogen and progesterone) oral contraceptives, combined
- •hormonal vaginal rings, hormone implants, hormone injectables, or
- •intrauterine device that need to be in place for a period of at least 2 months
- •prior to screening. Additional barrier contraception (the following methods are
- •allowed: condom of the male, diaphragm with spermicide, portio cap with
- •spermicide) must be used for the duration of the trial, defined as from the
- •time of screening to the end of trial examination, and for at least three full
- •months after dosing of trial medication.
排除标准
- •1. History or current evidence of clinically relevant allergies or idiosyncrasy
- •to drugs or food.
- •2. History of allergic reactions to pritelivir or the capsule material
- •(hydroxypropyl methyl cellulose [HPMC]).
- •3. History or current evidence of any clinically relevant cardiovascular,
- •pulmonary, hepatic, renal, gastrointestinal, hematological, endocrinological,
- •metabolic, neurological, psychiatric, or other disease suspected to influence
- •pharmacokinetics or safety of pritelivir.
- •4. History of malignancy.
研究者
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