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A Study to Investigate the Next-day Residual Effects of TS-142 in Healthy Elderly Subjects

A Study to Investigate the Next-day Residual Effects of TS-142 in Healthy Elderly Subjects

16

Age (years, Mean+-SD): 69.7+-3.0, Body weight (kg, Mean+-SD): 56.99+-8.36, Sex (n): Male 8 Female 8

16 subjects were randomized and allocated to 4 sequences, and all of them completed the study.

Adverse events were observed in 1 subject in placebo group, 2 in 5 mg group, 4 in 10 mg group and 3 in zopiclone group.

Root mean squares with eyes open (primary endpoint) in 5 mg group and 10 mg group were significantly smaller than in zopiclone group, and not statistically significant compared with placebo group.

Single administrations of TS-142 5 mg and 10 mg in the healthy elderly showed small residual effects in the next morning.

No

https://jrct.mhlw.go.jp/latest-detail/jRCT2071230009

Mita Seiji

Taisho Pharmaceutical Co., LTD.

3-24,1, Takada, Toshima-Ku, Tokyo

shu_chiken@taisho.co.jp

Development Headquarters Development Management

Taisho Pharmaceutical Co., LTD.

3-24,1, Takada, Toshima-Ku, Tokyo

+81-3-3985-1118

shu_chiken@taisho.co.jp

Complete

May. 12, 2023

Interventional

randomized controlled trial

double blind

placebo control

crossover assignment

other

1. Subjects who are Japanese male or female aged 65 years or older at the time of obtaining informed consent
2. Subjects with a body Mass Index (BMI) from 18.5 to less than 25.0 and a body weight of 40.0 kg or over at the screening test
3. Subjects who are judged by the principal investigators or subinvestigators as an eligible for the clinical trial participation based on the results of tests conducted in the screening, VISIT 1 and prior to the administration of the investigational drug.
Other protocol defined inclusion criteria could apply.

1. Subjects who are judged to have any disease by the principal investigator or sub-investigator and are not considered healthy
2. Subjects who have any unsuitable medical histories for participation in this clinical trial, including respiratory, cardiovascular, gastrointestinal, hepatic, renal, urological, endocrinological, metabolic, hematologic, immunologic, dermatological, neurological, or psychiatric diseases
3. Subjects who have any medical histories including sleep-associated symptoms, narcolepsy-like symptoms, suicidal ideation, or suicidal attempts.
Other protocol defined exclusion criteria could apply.

Both

Insomnia

single oral dose of 5 mg, 10 mg of TS-142 (INN: vornorexant), 7.5 mg of zopiclone, and placebo

RMS of COP: the area of the circle whose radius is the root mean square (RMS) value of center of pressure (COP) calculated by the stabilometer in eye-open condition

+81-92-283-7701

May. 11, 2023

none