Status:
COMPLETED
A Study in Healthy Adult Subjects to Evaluate the Safety, Tolerability, and Pharmacokinetic Profiles of Multiple Doses of ABT-072 Used to Treat Hepatitis C
Lead Sponsor:
Abbott
Conditions:
HCV Infection
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
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 singl...
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-072
Eligibility Criteria
Inclusion
- 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
- Use of medications including over the counter and vitamines.
- Abuse of alcohol, drugs, or nicotine.
- Current diseases or disorders.
- History of cardiac disease.
- If after consideration by the investigator, for any reason, that you are unsuitable to receive ABT-072.
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT00890318
Start Date
April 1 2009
Last Update
October 21 2010
Active Locations (1)
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1
Abbott Clinical Pharmaceutical Research Unit
Waukegan, Illinois, United States, 60085