Safety, Pharmacokinetic, and Pharmacodynamic Study of TS-142 in Healthy Subjects
Phase 2
Completed
- Conditions
- Healthy Volunteer
- Registration Number
- NCT04087707
- Lead Sponsor
- Taisho Pharmaceutical Co., Ltd.
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 23
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 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.
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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Sumida Hospital
🇯🇵Sumida-ku, Tokyo, Japan