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The purpose of this study is to determine multiple dose safety, tolerability and pharmacokinetics of ABT-072 under nonfasting conditions in healthy adult subjects, and to determine the effect of single dose administration of ketoconazole on steady state ABT-072 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-072
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Other | Healthy volunteers, receiving daily dose of 80 mg ABT-072 or placebo, QD for 10 days; and on Study Day 11 receiving a single dose of 80 mg ABT-072 or placebo + 400 mg ketoconazole |
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| 2 | Other | Healthy volunteers, receiving 160 mg ABT-072 or placebo, QD for 10 days. |
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| 3 | Other | Healthy volunteers, receiving 320 mg ABT-072 or placebo, QD for 10 days. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABT-072 | Drug | Powder contents from capsules mixed in an alternative vehicle, for additional information refer to Arm Description. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Analysis of pharmacokinetic results. | Study Days 1-13 | |
| 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. | Study Days -2 through 39 |
| Measure | Description | Time Frame |
|---|---|---|
| Analysis of single dose administration of ketoconazole on steady state ABT-072 pharmacokinetics. | Study Day 11-13 |
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Inclusion Criteria:
Main Selection Criteria for Healthy Volunteers:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel Cohen, MD | Abbott | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Abbott Clinical Pharmaceutical Research Unit | Waukegan | Illinois | 60085 | United States |
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| ketoconazole | Other | Tablet, see Arm Description for intervention information. |
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| Placebo | Drug | Capsule or powder drug substance from the capsule mixed in an alternative vehicle, for additional information refer to Arm Description. |
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| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| C000625346 | ABT-072 |
| D007654 | Ketoconazole |
| ID | Term |
|---|---|
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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