Effect of Food
Conditions
Brief summary
This is a study to assess the food effect of TS-142 preliminary market formulation tablet in healthy subjects
Interventions
DRUGTS-142 10 mg
Single-dose of 10 mg of TS-142
Sponsors
Taisho Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 39 Years
Healthy volunteers
Yes
Inclusion criteria
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.
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Plasma concentration | Predose and up to 24 hours postdose | Plasma concentration of unchanged form and its metabolite |
| Pharmacokinetic parameters | Predose and up to 24 hours postdose | Maximum plasma concentration of unchanged form and its metabolite (Cmax) |
Countries
Japan
Outcome results
None listed