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A Phase 1, Single-Center, Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Single Ascending and Multiple Dose of TS-172 in Healthy Adult Subjects
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A (single dose) : Step 1 to 4: TS-172 10 mg, 30 mg, 90 mg, 270 mg | Experimental | Single dose of TS-172 or placebo before breakfast |
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| Part B (multiple dose) : Step 5: TS-172 90 mg | Experimental | Multiple dose of TS-172 or placebo before breakfast and dinner |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TS-172 | Drug |
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence of treatment-emergent adverse events (TEAEs) and serious AEs (SAEs) | Part A (Step 1): Day 1 up to Day 8, Part A (Step 2, 3, 4): Day 1 up to Day 4, Part B: Day 1 up to Day 11 |
| Measure | Description | Time Frame |
|---|---|---|
| Concentration of unchanged form in plasma, urine and stool | Part A: Day 1 up to Day 4, Part B: Day 1 up to Day 11 | |
| Area under the plasma concentration-time curve (AUC) of unchanged form | Part A: Day 1 up to Day 4, Part B: Day 1 up to Day 11 |
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Inclusion Criteria:
Exclusion Criteria:
Subjects who have any disease and are not considered healthy subjects based on the medical judgment of the principal investigator or sub-investigator.
Those who correspond to any of the following about bowel movements;
Those who correspond to any of the following about bowel movements in the 7 days before administration;
Those who have a history of gastrointestinal ulceration
Those who correspond to any of the following about infection;
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| Name | Affiliation | Role |
|---|---|---|
| Taisho Director | Taisho Pharmaceutical Co., Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Taisho Pharmaceutical Co., Ltd selected site | Toshima-ku | Japan |
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| Placebo | Drug |
|
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| Mean daily urinaly excretion of sodium and phosphorus | Part A (Step 1): Day 1 up to Day 8, Part A (Step 2, 3, 4): Day 1 up to Day 4, Part B: Day 1 up to Day 11 |
| Mean daily Bristol Stool Form Scale (BSFS) | BSFS is a scale between 1-7, where 1 correlates with the firmest stool and 7 correlates with entirely liquid stool | Part A (Step 1): Day 1 up to Day 8, Part A (Step 2, 3, 4): Day 1 up to Day 4, Part B: Day 1 up to Day 11 |