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| Name | Class |
|---|---|
| Abbott Japan Co.,Ltd | INDUSTRY |
The objectives of this study is to assess the safety, tolerability, and pharmacokinetics of blind, escalating, single, oral doses of ABT-333 under nonfasting conditions in healthy male adult in Japan.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | Single dose of 400 mg |
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| Group 2 | Experimental | Single dose of 800 mg after safety evolution of Group I |
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| Group 3 | Experimental | Single dose of 1200 mg after safety evolution of Group 2 |
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| Group 4 | Experimental | Single dose of 1600 mg after safety evolution of Group 3 |
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| Group 5 | Placebo Comparator | Single dose of placebo |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABT-333 | Drug | Tablet, see arms for interventional description |
|
| Measure | Description | Time Frame |
|---|---|---|
| To assess single dose safety and tolerability of an ABT-333 tablet formulation relative to placebo by the evaluation of vital signs, ECGs, physical exams, clinical lab testing and adverse event monitoring | Daily assessment for 5 days then day 30 or more frequently as needed | |
| To evaluate single dose pharmacokinetics of an ABT-333 tablet formulation | Day 1-3 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yutaka Yamamura | Abbott | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site Reference ID/Investigator# 19102 | Kagoshima | 890-0081 | Japan |
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| ID | Term |
|---|---|
| C588260 | dasabuvir |
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| Placebo | Drug | Tablet, see arms for interventional description. |
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