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This is a Phase 1a study involving single oral dose of TS-134 in healthy male and female subjects. The safety, tolerability and pharmacokinetics of single dose of TS-134 will be evaluated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TS-134 | Experimental | Healthy adult subjects will be prospectively assigned to 1 of 4 cohorts. Within each cohort, 8 subjects will be randomized in a 3:1 ratio (6 active + 2 placebo) per cohort to receive TS-134 or placebo as a single oral dose solution. All cohorts will be dosed in a fasted state except for the 2nd and 4th (food effect) cohorts, which will be dosed first in a fasted state, and then in a fed state, in a single crossover design conducted with a washout between two periods. In the 3rd (CSF) cohort, 8 subjects will receive one dose level of TS-134 as a single-blind dosing assignment; there will be no placebo dosing. |
|
| Placebo | Placebo Comparator | Healthy adult subjects will be prospectively assigned to 1 of 4 cohorts. Within each cohort, 8 subjects will be randomized in a 3:1 ratio (6 active + 2 placebo) per cohort to receive TS-134 or placebo as a single oral dose solution. All cohorts will be dosed in a fasted state except for the 2nd and 4th (food effect) cohorts, which will be dosed first in a fasted state, and then in a fed state, in a single crossover design conducted with a washout between two periods. In the 3rd (CSF) cohort, the 8 subjects will receive one dose level of TS-134 as a single-blind dosing assignment; there will be no placebo dosing. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TS-134 | Drug | 5 mg, 10 mg, or 20 mg oral solution |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and severity of Adverse Events | Day 1 to Day 7 | |
| TS-134 Plasma Pharmacokinetic Profile - Cmax | Maximum plasma concentration | Day 1: predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48 hours post-dose |
| TS-134 Plasma Pharmacokinetic Profile - AUC(0-last) | Area under the concentration vs. time curve from time zero to last measurable concentration | Day 1: predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48 hours post-dose |
| TS-134 Plasma Pharmacokinetic Profile - tmax | Time to maximum plasma concentration | Day 1: predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48 hours post-dose |
| TS-134 Plasma Pharmacokinetic Profile - t1/2 | Apparent terminal elimination half-life | Day 1: predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48 hours post-dose |
| TS-134 Plasma Pharmacokinetic Profile - CL/F | Apparent clearance following oral administration | Day 1: predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48 hours post-dose |
| TS-134 Plasma Pharmacokinetic Profile - Vd/F | Apparent volumes of distribution following oral administration | Day 1: predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48 hours post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| TS-134 Cerebral Spinal Fluid (CSF) Pharmacokinetic Profile - Cmax | Maximum CSF concentration | Day 1: predose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24 hours post-dose |
| TS-134 CSF Pharmacokinetic Profile - AUC(0-last) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Taisho Director | Taisho Pharmaceutical R&D Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PAREXEL - Early Phase Clinical Unit-Los Angeles | Glendale | California | 91206 | United States |
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Double-blind
| Drug |
Matched Placebo oral solution |
|
Area under the CSF concentration vs. time curve from time zero to last measurable concentration
| Day 1: predose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24 hours post-dose |
| TS-134 CSF Pharmacokinetic Profile - tmax | Time to maximum CSF concentration | Day 1: predose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24 hours post-dose |
| TS-134 CSF Pharmacokinetic Profile - t1/2 | Apparent terminal elimination half-life (CSF) | Day 1: predose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24 hours post-dose |
| TS-134 CSF Pharmacokinetic Profile - CL/F | Apparent clearance (CSF) following oral administration | Day 1: predose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24 hours post-dose |
| TS-134 CSF Pharmacokinetic Profile - Vd/F | Apparent volumes of distribution (CSF) following oral administration | Day 1: predose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24 hours post-dose |