JPRN-jRCT2071210007招募中1 期
A Randomized, Double-blind, Placebo-Controlled Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Doses of TAK-861 in Healthy Adult and Elderly Subjects and Subjects With Narcolepsy Type 1
onomura Hidenori0 个研究点目标入组 263 人开始时间: 2021年4月8日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 263
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
- >= 18age old 至 ot applicable（—）
- 性别
- All
入选标准
- •Healthy Adult Participants for Part A, B, C:
- •1. Must be normotensive, with no history of hypertension or use of antihypertensive medication. Blood pressure (BP) must be less than (<) 140 millimeter of mercury (mmHg) (systolic) and <90 mmHg (diastolic) at screening and at Day -1.
- •2. Must be a current nonsmoker who has not used tobacco- or nicotine-containing products (example, nicotine patch) for at least 6 months before the first dose of study drug or first study assessment.
- •Healthy Adult Participants (Parts A, B):
- •3. Must be aged 18 to 55 years, inclusive, at the screening visit.
- •4. Must have a body weight >=50 kg at the screening visit.
- •Healthy Elderly Participants (Part C):
- •5. Must be aged >=65 years, inclusive, at the screening visit.
- •6. Must have a body weight >=40 kg at the screening visit.
- •Participants With NT1 (Parts D):
- •7. Must be aged 18 to 64 years, inclusive, at the time of informed consent.
- •8. Must have a diagnosis of NT1 by polysomnography (PSG)/multiple sleep latency test (MSLT) performed within the past 10 years meeting the minimal acceptable criteria for the proper performance of PSG/MSLT as outlined by the ICSD-3 criteria.
- •9. ESS score must be >=10 at Day -1.
- •10. Must be willing to discontinue all medications used for the treatment of NT1.
- •11. The participant must have a BMI >=18.0 and =<40 kg/m2 at the screening visit.
- •12. The participant must have BP <140 mm Hg (systolic) and <90 mm Hg (diastolic) at the screening visit and Day -2.
排除标准
- •All Participants:
- •1. Have a known hypersensitivity to any component of the formulation of TAK 861 or related compounds.
- •2. Consumes excessive amounts, defined as greater than 600mg of caffeine of coffee, tea, cola, energy drinks, or other caffeinated beverages per day.
- •Participants With NT1 for Parts D - Additional Criteria
- •3. Have a medical disorder, other than narcolepsy, associated with EDS.
- •4. Have any other medical condition, such as anxiety, depression, heart disease, or hepatic, pulmonary, or renal disease, that requires the participant to take excluded medications or at the time of screening the participant is being treated with nasal/oronasal PAP for any reason.
- •5. Have a nicotine dependence that is likely to have an effect on sleep (eg, a participant who routinely awakens at night to smoke) and/or an unwillingness to discontinue all smoking and nicotine use during the confinement portions of the study.
研究者
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