A 3-Part, Randomized, Double-Blind, Placebo-Controlled, Multiple Rising Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of TAK-925 in Healthy Volunteers and Patients with Narcolepsy

TAKEDA PHARMACEUTICAL COMPANY LTD.1 个研究点目标入组 57 人开始时间: 待定最近更新: 2020年11月4日

试验速览

阶段: 1 期
状态: 已完成
发起方
入组人数: 57
试验地点: 1
主要终点: Number of Participants who Experience at Least One Treatment-Emergent Adverse Events (TEAE)

暂无简介。

研究类型: Interventional
干预模型: Randomized, Double-Blind, Placebo-Controlled, Multiple Rising Dose Study
主要目的: Treatment Purpose

•Healthy adult participants and Healthy elderly participants:
•Participant weighs at least 50 kg (Healthy adults participants) / 40 kg (Healthy elderly participants) and has a body mass index (BMI) from 18.5 to 30 kg/m^2, inclusive at Screening.
•Narcolepsy patients:
•Patient weighs at least 40 kg inclusive at Screening (>=50 kg is required for Cohort B4).
•A diagnosis of narcolepsy, as defined by the International Classification of Sleep Disorders, Third Edition (ICSD-3).
•At Day -1, Epworth sleepiness scale (ESS) score >=10

•All Participants:
•Participants consume excessive amounts, defined as greater than 6 servings (1 serving is approximately equivalent to 120 mg of caffeine) of coffee, tea, cola, energy drinks, or other caffeinated beverages per day.
•Participants have a moderate to severe substance use disorder.
•Participants have a risk of suicide according to endorsement of item 4 or 5 with Screening/Baseline visit C-SSRS or has made a suicide attempt in the previous 6 months.
•Participants have a lifetime history of major psychiatric disorder, such as bipolar disorder or schizophrenia.
•Participants experienced sleep wake cycle disturbance with external factors such as irregular work hours.

Number of Participants who Experience at Least One Treatment-Emergent Adverse Events (TEAE)

时间窗: From the first dose of study drug up to 7 days after the last dose of study drug (up to Day 15)

safety

Rac (AUC): Accumulation Ratio Based on AUCtau for TAK-925(Part A,Days 1,7:pre-infusion(inf),0.5,1, 1.5, 2, 4, 6, 8, 9 hours(h)post start of inf;0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 6, 10, 15 h post end of inf;Part B,C:Days 1,7:Pre-inf, 1, 2, 4, 6, 9 h post start of inf; 0.17, 0.5, 2, 6, 10, 15 h post end of inf)
Change from Baseline in Sleep Latency in the Maintenance of Wakefulness Test (MWT) at Days 1 and 7(Baseline,Day 1 and to Day 7)

发起方

TAKEDA PHARMACEUTICAL COMPANY LTD.

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