A Clinical Pharmacological Study of TS-142 in Non-Elderly and Elderly Healthy Participants (A Repeated-Dose Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of TS-142 in Elderly and Non-Elderly Participants)
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 23
- Locations
- 2
- Primary Endpoint
- Step2; Subjective Alertness via Karolinska Sleepiness Scale (KSS)
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Masking Description
Step1; No masking
Eligibility Criteria
- Ages
- 20 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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 exclusion criteria could apply
Outcomes
Primary Outcomes
Step2; Subjective Alertness via Karolinska Sleepiness Scale (KSS)
Time Frame: 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.
Incidence of Treatment-emergent Adverse Events (TEAEs) and Serious AEs (SAEs)
Time Frame: 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)
Time Frame: Day 1 up to Day 9
Concentration of TS-142 and its metabolites in plasma
Secondary Outcomes
No secondary outcomes reported