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Sponsored by: |
Abbott |
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Information provided by: | Abbott |
ClinicalTrials.gov Identifier: | NCT00890318 |
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.
Condition | Intervention | Phase |
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HCV Infection |
Drug: ABT-072 Other: ketoconazole Drug: Placebo |
Phase I |
Study Type: | Interventional |
Study Design: | Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Single Group Assignment |
Estimated Enrollment: | 32 |
Study Start Date: | April 2009 |
Estimated Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1
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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Drug: ABT-072
Powder contents from capsules mixed in an alternative vehicle, for additional information refer to Arm Description.
Other: ketoconazole
Tablet, see Arm Description for intervention information.
Drug: Placebo
Capsule or powder drug substance from the capsule mixed in an alternative vehicle, for additional information refer to Arm Description.
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2
Healthy volunteers, receiving 160 mg ABT-072 or placebo, QD for 10 days.
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Drug: ABT-072
Powder contents from capsules mixed in an alternative vehicle, for additional information refer to Arm Description.
Drug: Placebo
Capsule or powder drug substance from the capsule mixed in an alternative vehicle, for additional information refer to Arm Description.
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3
Healthy volunteers, receiving 320 mg ABT-072 or placebo, QD for 10 days.
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Drug: ABT-072
Powder contents from capsules mixed in an alternative vehicle, for additional information refer to Arm Description.
Drug: Placebo
Capsule or powder drug substance from the capsule mixed in an alternative vehicle, for additional information refer to Arm Description.
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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
Ages Eligible for Study: | 18 Years to 55 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Main Selection Criteria for Healthy Volunteers:
Exclusion Criteria:
Contact: Renee Heuser | 847-938-5887 | renee.heuser@abbott.com |
United States, Illinois | |
Global Medical Information | |
Abbott Park, Illinois, United States, 60064 |
Responsible Party: | Abbott ( Daniel Cohen, MD/Study Medical Director ) |
Study ID Numbers: | M10-705 |
Study First Received: | April 27, 2009 |
Last Updated: | April 28, 2009 |
ClinicalTrials.gov Identifier: | NCT00890318 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Hepatitis Clotrimazole Miconazole Antifungal Agents |
Tioconazole Healthy Hepatitis C Ketoconazole |
Anti-Infective Agents Therapeutic Uses Antifungal Agents |
Ketoconazole Infection Pharmacologic Actions |