NL-OMON51974已完成不适用
A clinical trial to evaluate the safety, tolerability, and pharmacokinetics of single and multiple ascending oral doses of LEO 153339 in healthy subjects - A single and multiple ascending dose trial of LEO 153339 in healthy adults
eo Pharma A/S0 个研究点目标入组 134 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
- 发起方
- 入组人数
- 134
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
- •Healthy adult males and females.
- •Age between 18 and 65 years (both inclusive) at screening.
- •A body mass index (BMI) between 18.0 and 32.0 kg/m2 (both inclusive).
- •In good health at screening and/or check-in (Day -2 and Day -1) as judged by
- •the investigator based on medical history, physical examination, vital signs,
- •12 lead ECG, and clinical laboratory evaluations.
排除标准
- •Male subjects sexually active with a woman of childbearing potential who are
- •not willing to use a barrier method of contraception (e.g. condom) from the
- •time of first dose of IMP until 3 months after the last dose, in conjunction
- •with this female partner using a highly effective form of contraception. For
- •vasectomised male subjects, male subjects with a female partner with bilateral
- •tubal occlusion or ligation, and heterosexually abstinent male subjects (when
- •this is in line with the
- •preferred and usual life style of the subject and not just being without a
- •current partner), no additional contraception is required.
- •Female subjects who are pregnant, lactating, or of childbearing potential
- •Any surgical or medical condition or cholecystectomy which might significantly
- •alter the absorption, distribution, metabolism, or excretion of any drug.
- •Positive polymerase chain reaction (PCR) test for coronavirus disease 2019
- •(COVID-19) at Day -2 or Day -1 or within 8 weeks prior to screening or
- •check-in, or contact with COVID-19 positive (or suspected) persons within 14
- •days prior to first dose.
- •Treatment with any prescribed or non-prescribed systemic or topical medication
- •within 7 days prior to the first dose of IMP (excluding paracetamol; including
- •herbal remedies), unless, in the opinion of the investigator and the sponsor,
- •the medication will not interfere with the trial procedures or compromise
- •Treatment with any non-marketed drug substance (that is, an agent which has not
- •yet been made available for clinical use following registration) within 3
- •months prior to the first dose of IMP.
- •ECG with QT interval corrected for heart rate using Fridericia's formula (QTcF)
- •>450 msec confirmed by repeat measurement at screening.
研究者
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