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A Study to Assess the Food Effect of TS-142 in Healthy Subjects

A Food Effect Study of TS-142 in Healthy Subjects

12

Age (years): Mean+-SD 24.9+-4.7, Body Weight (kg): Mean+-SD 62.79+-5.05

12 subjects were randomized and allocated to 2 sequences, and completed the study.

The adverse events were observed in 5 out of 12 subjects in both fasted condition and fed condition.

The administration of TS-142 under fed condition slightly increased the AUC and prolonged the tmax of unchanged form compared to administration under fasted condition, but there were no significant difference in Cmax and t1/2.

The administration of TS-142 under fed condition slightly increased the AUC and prolonged the tmax of unchanged form compared to administration under fasted condition. No diffecence in safety between both conditions was observed.

No

https://jrct.mhlw.go.jp/latest-detail/jRCT2071220103

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

Feb. 10, 2023

Interventional

randomized controlled trial

open(masking not used)

uncontrolled control

crossover assignment

other

1.Japanese male who are aged 18 years or older but less than 40 years at the time of informed consent
2.Body Mass Index (BMI) of 18.5 or more and less than 25.0 at the screening test
3.Subjects who are judged by the investigators as an eligible for the clinical trial participation based on the screening tests and the tests conducted at treatment period 1.
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 history for participation in this study, 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.

Male

Insomnia

Single oral dose of 10 mg of TS-142 (INN:vornorexant)

Plasma concentration of unchanged form and its metabolites

+81-92-283-7701

Feb. 09, 2023

none