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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-003161-34 | EudraCT Number |
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This open label, Phase 1 study is to investigate the relative bioavailability of ABT-333 when delivered within different sites of the gastrointestinal tract in 12 healthy subjects.
Bioavailability of ABT-333 in different areas of the gut
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: ABT-333 | Experimental | A single centre, open-label, 4-treatment, 3-period, 4-sequence incomplete randomised, single dose crossover study in healthy subjects. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABT-333 | Drug | Dose of ABT-333 |
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| Measure | Description | Time Frame |
|---|---|---|
| ABT-333 drug concentrations | ABT-333 concentrations in blood | Day 1 until 24 hours after single dose of ABT-333 for each period |
| Measure | Description | Time Frame |
|---|---|---|
| Physical Exam | To examine any change from Day-1 in the subject's physical presentation(body temperature, pulse, blood pressure). | Day-1 until 24 hours after single dose of ABT-333 for each period |
| Electrocardiograms (ECGs) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dan Cohen, MD | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site Reference ID/Investigator# 118435 | Nottingham | NG11 6JS | United Kingdom |
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| ID | Term |
|---|---|
| C588260 | dasabuvir |
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The measure of any change in 12 lead electrocardiogram from Day-1
| Day-1 until 3 hours after single dose of ABT-333 for each period |
| Safety Labs | Chemistry, Hematology, Urinalysis | Day-1 until 24 hours after single dose ABT-333 for each period |
| Number of participants with Adverse Events | Screening until after 7 days after last dose of ABT-333 |
| Relative bioavailability | The measure of ABT-333 in different areas of the gastrointestinal tract | Day-1 until 24 hours after single dose of ABT-333 for each period |