Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04696952 | A Study to Evaluate Next Day Effects of TS-142 on Driving Performance in Healthy Subjects | PHASE1 | COMPLETED | 61 | — | — | Jan 16, 2021 | Jan 5, 2022 | Feb 28, 2025 | 1 | Japan |
| Arm | Type | Description |
|---|---|---|
| TS-142 10 mg | EXPERIMENTAL | Period in which subjects received TS-142 10 mg |
| TS-142 20 mg | EXPERIMENTAL | Period in which subjects received TS-142 20 mg |
| Zopiclone 7.5 mg | EXPERIMENTAL | Period in which subjects received Zopiclone 7.5 mg |
| Placebo | EXPERIMENTAL | Period in which subjects received placebo |
| Name | Type | Description |
|---|---|---|
| TS-142 | DRUG | TS-142 |
| Zopiclone | DRUG | Zopiclone |
| Placebo | DRUG | Placebo |
Inclusion Criteria: * Males and females aged 21 years or older but less than 80 years at the time of informed consent * Those with a BMI of 18.5 or more and less than 25.0 and a body weight of 40.0 kg or more at screening tests * Have an ordinary driving license and have driven on a daily basis for...