15 completed. 11 Phase 1, 2 Phase 2, 2 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 11 | Completed 11 |
| Phase 2 | 2 | Completed 2 |
| Phase 3 | 2 | Completed 2 |
Follow TS-142: new trials by email Literature Review of TS-142 trials Research Report on TS-142
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| A Study to Investigate the Next-day Residual Effects of TS-142 in Healthy Elderly Subjects TS-142, Zopiclone, Placebo - Healthy Subjects | Phase 1 | Completed | Taisho Pharmaceutical Co., Ltd. | 43 | 2023-05-15 | 2025-02-28 |
| A Food Effect Study of TS-142 in Healthy Subjects TS-142 10 mg - Effect of Food | Phase 1 | Completed | Taisho Pharmaceutical Co., Ltd. | 12 | 2023-02-15 | 2025-02-28 |
| A Pharmacokinetic Study of TS-142 in Patients with Hepatic Impairment TS-142 5 mg - Patients with Mild or Moderate Hepatic Impairment | Phase 1 | Completed | Taisho Pharmaceutical Co., Ltd. | 84 | 2022-12-26 | 2025-02-28 |
| Long-Term Study of TS-142 in Patients with Insomnia TS-142 5 mg, TS-142 10 mg - Patients with Insomnia | Phase 3 | Completed | Taisho Pharmaceutical Co., Ltd. | 401 | 2022-10-11 | 2025-02-28 |
| Phase III Study of TS-142 in Patients with Insomnia TS-142 5 mg, TS-142 10 mg, Placebo to TS-142 - Patients with Insomnia | Phase 3 | Completed | Taisho Pharmaceutical Co., Ltd. | 1155 | 2022-08-30 | 2025-02-28 |
| A QT/QTc Evaluation Study of TS-142 in Healthy Adult Subjects TS-142, Moxifloxacin, Placebo - Healthy Subjects | Phase 1 | Completed | Taisho Pharmaceutical Co., Ltd. | 59 | 2021-06-07 | 2025-02-28 |
| Mass Balance Study of TS-142 in Healthy Adult Subjects. [14C] TS-142 - Healthy Male Subjects | Phase 1 | Completed | Taisho Pharmaceutical Co., Ltd. | 6 | 2021-04-19 | 2025-02-28 |
| A Clinical Pharmacology Study of TS-142 in Patients with Obstructive Sleep Apnea Hypopnea. TS-142, Dose-matched Placebo to TS-142 - Patients with Mild Obstructive Sleep Apnea Hypopnea | Phase 1 | Completed | Taisho Pharmaceutical Co., Ltd. | 46 | 2021-02-24 | 2025-02-28 |
| A Study to Evaluate Next Day Effects of TS-142 on Driving Performance in Healthy Subjects TS-142, Zopiclone, Placebo - Healthy Subjects | Phase 1 | Completed | Taisho Pharmaceutical Co., Ltd. | 61 | 2021-01-16 | 2025-02-28 |
| Drug-drug Interaction Study with TS-142 in Healthy Adult Subjects (concomitant Administration of Itraconazole) TS-142, Itraconazole - Healthy Subjects | Phase 1 | Completed | Taisho Pharmaceutical Co., Ltd. | 10 | 2020-10-13 | 2025-02-28 |
| A Single Ascending and Repeated Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of TS-142 in Healthy Participants TS-142, TS-142 Placebo - Healthy Volunteers | Phase 1 | Completed | Taisho Pharmaceutical R&D Inc. | 28 | 2020-09-14 | 2021-02-10 |
| Late Phase II Study of TS-142 in Patients with Insomnia TS-142 - Patients with Insomnia | Phase 2 | Completed | Taisho Pharmaceutical Co., Ltd. | 179 | 2020-09-09 | 2025-02-28 |
| Early Phase 2 Clinical Study of TS-142 in Patients with Insomnia Disorder TS-142, Dose-matched Placebo to TS-142 - Insomnia Disorder | Phase 2 | Completed | Taisho Pharmaceutical Co., Ltd. | 24 | 2017-07-07 | 2025-02-28 |
| A Phase I Study of TS-142 in Healthy Participants (Repeated Doses) Placebo, TS-142, 10 mg, TS-142, 20 mg - Healthy Volunteer | Phase 1 | Completed | Taisho Pharmaceutical Co., Ltd. | 24 | 2016-07-06 | 2025-02-28 |
| A Phase I Study of TS-142 in Healthy Participants (Single Doses) Placebo (fasting), Placebo (feeding), 1 mg of TS-142 - Healthy Volunteer | Phase 1 | Completed | Taisho Pharmaceutical Co., Ltd. | 32 | 2015-10-17 | 2025-02-28 |
Sleep Initiation and Maintenance Disorders (1)
Taisho Pharmaceutical Co., Ltd. (14) · Taisho Pharmaceutical R&D Inc. (1)
Japan (14) · United States (1)
Taisho Direcoter (3) · Shigeru Okuyama (2) · Toshiro Heya (1)