Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to investigate the safety and pharmacokinetics of single dosing of TS-142 to healthy Japanese non-elderly participants in fasting and after meal condition.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm Title: Placebo (fasting) | Placebo Comparator | fasting |
|
| Placebo (feeding) | Placebo Comparator | after meal |
|
| TS-142, 1 mg | Experimental | fasting |
|
| TS-142, 3 mg | Experimental | fasting |
|
| TS-142, 10 mg (fasting) | Experimental | fasting |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo (fasting) | Drug | Participants will receive placebo once in fasting condition |
|
| 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 8 |
| Area under the concentration-time curve AUC (tau) | Concentration of TS-142 and its metabolites in plasma | 48 hours |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Shigeru Okuyama | Taisho Pharmaceutical Co., Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The medical facility selected by Taisho Pharmaceutical Co., Ltd | Fukuoka | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| C000723815 | TS-142 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| TS-142, 10 mg (feeding) | Experimental | after meal |
|
| TS-142, 30 mg | Experimental | fasting |
|
| Placebo (feeding) | Drug | Participants will receive placebo once after meal condition |
|
| 1 mg of TS-142 | Drug | Participants will receive 1 mg of TS-142 once in fasting condition |
|
| 3 mg of TS-142 | Drug | Participants will receive 3 mg of TS-142 once in fasting condition |
|
| 10 mg of TS-142 (fasting) | Drug | Participants will receive 10 mg of TS-142 once in fasting condition |
|
| 10 mg of TS-142 (feeding) | Drug | Participants will receive 10 mg of TS-142 once after meal condition |
|
| 30 mg of TS-142 | Drug | Participants will receive 30 mg of TS-142 once in fasting condition |
|