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 and elderly participants
Interventions
DRUGStep 1: TS-142
Non-elderly participants will receive 20 mg of TS-142 once daily for 7 consective days
DRUGStep 2: TS-142
Elderly participants will receive 20 mg of TS-142 once daily for 7 consective days
DRUGStep 2: Placebo
Elderly participants will receive placebo once daily for 7 consective days
Sponsors
Taisho Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
Step1; No masking
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Body mass index (BMI) ≥18.5 and \<25.0 kg/m\^2 and body weight is more than 40.0 kg at screening inspection * Other protocol defined inclusion criteria could apply
Exclusion criteria
* History of clinically relevant disease of any organ system that may interfere with the objectives of the study or provide a risk to the health of the participant * History of drug and food allergy * Other protocol defined
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 |
| Step2; Subjective Alertness via Karolinska Sleepiness Scale (KSS) | Day 1 up to Day 8 | Step2; as a measure of subjective alertness which is scored by 10 cm-VAS scale ranging from 1, extremely alert, to 9, extremely sleepy at the next morning after administration. |
Countries
Japan
Outcome results
None listed