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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Step 1;TS-142 | Experimental |
| |
| Step 2;TS-142 | Experimental |
| |
| Step 2;Placebo | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Step 1: TS-142 | Drug | Non-elderly participants will receive 20 mg of TS-142 once daily for 7 consective days |
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment-emergent Adverse Events (TEAEs) and Serious AEs (SAEs) | Number of Treatment-emergent Adverse Events (TEAEs) and Serious AEs (SAEs) reported as mild, moderate, severe | Day 1 up to Day 14 |
| Area under the concentration-time curve AUC (tau) | Concentration of TS-142 and its metabolites in plasma | Day 1 up to Day 9 |
| Step2; Subjective Alertness via Karolinska Sleepiness Scale (KSS) | 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. | Day 1 up to Day 8 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Taisho Director | Taisho Pharmaceutical Co., Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sumida Hospital | Sumida-ku | Tokyo | 130-0004 | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37563858 | Result | Kambe D, Hasegawa S, Imadera Y, Mano Y, Matsushita I, Konno Y, Ogo H, Uchimura N, Uchiyama M. Pharmacokinetics, pharmacodynamics and safety profile of the dual orexin receptor antagonist vornorexant/TS-142 in healthy Japanese participants following single/multiple dosing: Randomized, double-blind, placebo-controlled phase-1 studies. Basic Clin Pharmacol Toxicol. 2023 Nov;133(5):576-591. doi: 10.1111/bcpt.13930. Epub 2023 Sep 10. |
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Step1; No masking
| Step 2: TS-142 | Drug | Elderly participants will receive 20 mg of TS-142 once daily for 7 consective days |
|
| Step 2: Placebo | Drug | Elderly participants will receive placebo once daily for 7 consective days |
|