Healthy Volunteer
Conditions
Brief summary
The purpose of this study is to investigate the safety, pharmacokinetics, and pharmacodynamics of repeated dosing of TS-142 when administered once daily to healthy Japanese non-elderly participants.
Interventions
DRUGPlacebo
Participants will receive placebo once daily for 7 consective days
DRUGTS-142, 10 mg
Participants will receive 10 mg of TS-142 once daily for 7 consective days
DRUGTS-142, 20 mg
Participants will receive 20 mg of TS-142 once daily for 7 consective days
DRUGTS-142, 30 mg
Participants will receive 30 mg of TS-142 once daily for 7 consective days
Sponsors
Taisho Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
MALE
Age
20 Years to 39 Years
Healthy volunteers
Yes
Inclusion criteria
* Body mass index (BMI) ≥18.5 and \<25.0 kg/m\^2 at screening inspection
Exclusion criteria
* History of clinically relevant disease of some organ systems that may be considerd inappropriately for this study * History of drug and food allergy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Treatment-emergent Adverse Events (TEAEs) and Serious AEs (SAEs) | Day 1 up to Day 14 | Number of Treatment-emergent Adverse Events (TEAEs) and Serious AEs (SAEs) reported as mild, moderate, severe |
| Area under the concentration-time curve AUC (tau) | Day 1 up to Day 9 | Concentration of TS-142 and its metabolites in plasma |
Countries
Japan
Outcome results
None listed