JPRN-jRCT2061230047已完成1 期
Interventional, exploratory, open-label trial investigating thesafety, tolerability, pharmacokinetics and pharmacodynamicproperties of Lu AF28996 in Japanese men and women withParkinson's disease
Yazawa Masanari0 个研究点目标入组 6 人开始时间: 2023年8月12日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 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
- >= 45age old 至 <= 75age old（—）
- 性别
- All
入选标准
- •1. The participant is diagnosed with idiopathic PD (consistent with the United Kingdom Parkinson's Disease Society Brain Bank Criteria for the Diagnosis of Parkinson's Disease) and should not have more than 1 first-degree relative with PD.
- •2. The participant experiences well recognizable and predictable motor fluctuations (>=1.5 hours of OFF-periods in the awake time, predictable morning OFF episodes included) causing clinically significant disability during the 7-week Screening Period.
- •3. The participant currently has a good response to levodopa and has been receiving a stable dose of levodopa >=3 doses per day of levodopa/dopa decarboxylase inhibitor therapy) >=4 weeks prior to screening.
- •4. The participant is >=45 and <=75 years o f age at the Screening Visit.
- •5. If the participant is a man, he must:
- •- have been surgically sterilized (bilateral surgical vasectomy or bilateral orchiectomy) prior to the Screening Visit
- •- remain sexually abstinent, when this is in line with his preferred and usual lifestyle
- •- engage exclusively in same-sex relationships
- •- engage in sexual relationships with a female partner of non-childbearing potential, defined as:
- •- a woman who had her last natural menstruation >=12 months prior to the Screening Visit OR
- •- a woman who was surgically sterilized (bilateral fallopian tubal ligation, bilateral salpingo oophorectomy, or bilateral oophorectomy) or had a hysterectomy prior to the Screening Visit
- •- agree to avoid impregnating his partner, if the partner is considered to be of childbearing potential, from the Screening Visit until >=3 months after the last dose of IMP by using contraception
- •- not donate sperm from the Screening Visit until >=3 months after the last dose of IMP
- •6. If the participant is a woman, considered to be of childbearing potential, she must:
- •- remain sexually abstinent, when this is in line with her preferred and usual lifestyle
- •- engage exclusively in same-sex relationships
- •- have a male partner who was surgically sterilized (bilateral surgical vasectomy or bilateral orchiectomy) prior to the Screening Visit
- •agree to avoid becoming pregnant from the Screening Visit until >=1 month after the last dose of IMP by using a highly effective method of contraception
- •- not donate ova from the Screening Visit until >=1 month after the last dose of IMP
排除标准
- •1. The participant is a member of the site staff or of their immediate families, or is a subordinate (or immediate family member of a subordinate) to any of the site staff.
- •2. The participant has taken any investigational medicinal product <3 months or <5 half-lives, whichever is longer, prior to the Screening Visit.
- •3. The participant is pregnant or breastfeeding, intends to become pregnant, or is of childbearing potential and not willing to use adequate contraceptive methods.
- •4. The participant has undergone any eye surgery within 3 months prior to the Screening Visit.
- •5. The participant has a disease or takes medication that could, in the opinion of the investigator, interfere with the assessments of safety, tolerability, or pharmacodynamics, or interfere with the conduct or interpretation of the trial.
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