A Study in Healthy Adult Subjects to Evaluate the Safety, Tolerability, and Pharmacokinetics of Multiple Doses of ABT-333
Information source: Abbott
Information obtained from ClinicalTrials.gov on February 12, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: HCV Infection
Intervention: ABT-333 (Drug); ketoconazole (Drug); placebo (Drug)
Phase: Phase 1
Status: Recruiting
Sponsored by: Abbott Overall contact:
Debbie Tokimoto, Phone: 847-938-9415, Email: debbie.tokimoto@abbott.com
Summary
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
Clinical Details
Study design: Other, Randomized, Double Blind (Subject, Caregiver, Investigator), Single Group Assignment
Primary outcome: Analysis of pharmacokinetic results.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.
Secondary outcome: Analysis of single dose administration of ketoconazole on steady state ABT-333 pharmacokinetics.
Detailed description:
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
Eligibility
Minimum age: 18 Years.
Maximum age: 55 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Main Selection Criteria for Healthy Volunteers:
- Subject has provided written consent.
- Subject is in general good health.
- 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:
- See above for main selection criteria
Locations and Contacts
Debbie Tokimoto, Phone: 847-938-9415, Email: debbie.tokimoto@abbott.com
Global Medical Information, Abbott Park, Illinois 60064, United States; Recruiting
Phone: 800-633-9110, Email: medinfo@abbott.com
Additional Information
Starting date: October 2008
Last updated: January 26, 2009
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