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| Name | Class |
|---|---|
| Otsuka Pharmaceutical Co., Ltd. | INDUSTRY |
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The objective of this trial is to evaluate the safety and tolerability of single and multiple ascending oral doses of OPS-2071 in healthy male Korean
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part1 : OPS-2071 | Experimental | Single dose, OPS-2071 30,60,120,240,300,600,900,1200mg/day |
|
| Part1 : Placebo of OPS-2071 | Placebo Comparator | Single dose, Placebo |
|
| Part2 : OPS-2071 | Experimental | Multiple dose |
|
| Part2 : Placebo of OPS-2071 | Placebo Comparator | Multiple doses, Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Part1 : OPS-2071 | Drug | single oral dose under fasted condition |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Part1 : adverse event, body weight, physical examination, vital sign, electrocardiogram, clinical laboratory test | 4days | |
| Part2 : adverse event, body weight, physical examination, vital sign, electrocardiogram, clinical laboratory test, Bond and Lader visual analogue scale (BL VAS) | Bond and Lader VAS: Day -1 and last dosing day (within 1 hour of expected Cmax) | 21days |
| Measure | Description | Time Frame |
|---|---|---|
| Part1 : Plasma pharmacokinetic parameters of OPS-2071 | Cmax, tmax, AUC and so on. | pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48 and 72 hours post-dose |
| Part2 : Plasma Pharmacokinetic parameters of OPS-2071 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| InJin Jang, M.D.,Ph.D. | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | South Korea |
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| Part1 : Placebo of OPS-2071 |
| Drug |
single oral dose under fasted condition |
|
| Part2 : OPS-2071 | Drug | multiple twice-daily oral dosing for 5-7days |
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| Part2 : Placebo of OPS-2071 | Drug | multiple twice-daily oral dosing for 5-7days |
|
Cmax, tmax, AUCtau, C12 and so on.
| Day 1: pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12 hours post-morning-dose , Days 2 to 6: pre morning and evening dose, last dosing day: pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48 and 72 hours post-dose. |
| Part1 : Urine Pharmacokinetic parameter of OPS-2071 | Day 1: pre-dose, 0-4, 4-8, 8-12, 12-24, 24-48 and 48-72 hours post-dose |
| Part2 : Urine pharmacokinetic parameter of OPS-2071 | Day 1 and last dosing day : pre-morning dose, 0-4 post-morning dose, 4-8 post-morning dose and 8-12 hours post-morning dose. |
| Part1 : Fecal pharmacokinetic parameters of OPS-2071 | Feces sample is collected in the 120-mg group only: All post-dose samples will be collected until discharge. Actual sampling time point will be recorded. | All post-dose samples |
| Part2 : Microflora test | Pre-dose, last dosing day to the day of discharge,. Day 21 |