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The purpose of this study is to determine multiple dose safety, tolerability and pharmacokinetics of ABT-333 under nonfasting conditions in healthy adult subjects, and to determine the effect of single dose administration of ketoconazole on steady state ABT-333 pharmacokinetics
Phase 1, Blinded, Randomized, Placebo-controlled Study in Healthy Adult Subjects to Evaluate the Safety, Tolerability, and Pharmacokinetic Profiles of Multiple Doses of ABT-333
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Other | Healthy volunteers, receiving daily doses of 200 mg ABT-333 or placebo, BID for 10 days; and on Study Day 11 receiving a single dose of 200 mg ABT-333 or placebo + 400 mg ketoconazole |
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| 2 | Other | Healthy volunteers, receiving 400 mg ABT-333 or placebo, BID |
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| 3 | Other | Healthy volunteers, receiving 600mg ABT-333 or placebo, BID |
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| 4 | Other | Healthy volunteers, receiving 1000mg ABT-333 or placebo, BID |
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| 5 | Other | Healthy volunteers, receiving 1600mg ABT-333 or placebo, BID* *After review of the data from previous groups, and in accordance with the protocol, this arm was not dosed. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABT-333 | Drug | Capsule, or powder drug substance from the capsule powder mixed in an alternate vehicle. For additional information refer to arm description. |
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| Measure | Description | Time Frame |
|---|---|---|
| Analysis of pharmacokinetic results. | Approximately 1 week. | |
| Analysis of safety measures including but not limited to tabulation of adverse events, physical exam, clinical lab results (include chemistry, hematology and urine) and vital signs. | Approximately 1 week. |
| Measure | Description | Time Frame |
|---|---|---|
| Analysis of single dose administration of ketoconazole on steady state ABT-333 pharmacokinetics. | Approximately 1 week. |
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Inclusion Criteria:
Main Selection Criteria for Healthy Volunteers:
If female, subject is postmenopausal for at least 2 years or surgically sterile.
If female, subject is not pregnant and is not breast-feeding.
Male or female between 18 and 55 years old, inclusive.
If male, subject must be surgically sterile or practicing at least 1 method of birth control.
Body Mass Index (BMI) is 18 to 29, inclusive.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site Reference ID/Investigator# 12701 | Waukegan | Illinois | 60085 | United States |
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| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
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| ID | Term |
|---|---|
| C588260 | dasabuvir |
| D007654 | Ketoconazole |
| ID | Term |
|---|---|
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| ketoconazole | Drug | Tablet, see arms for intervention description |
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| placebo | Drug | Capsule or powder drug substance from the capsule powder mixed in an alternative vehicle. For additional information refer to arm description. |
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| D014777 |
| Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |