Status:
COMPLETED
Study in Healthy Adults to Evaluate Pharmacokinetics, Safety and Tolerability of ABT-450 With Ritonavir
Lead Sponsor:
Abbott
Conditions:
HCV Infection
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to evaluate the pharmacokinetics, safety and tolerability of multiple doses of an experimental hepatitis C virus (HCV) protease inhibitor with ritonavir in healthy volunte...
Detailed Description
This is a multiple ascending dose, non-fasting, open label, randomized study.
Eligibility Criteria
Inclusion
- overall healthy subjects
- non-childbearing potential females included
Exclusion
- history of significant sensitivity to any drug
- positive test for HAV IgM, HBsAg, anti-HCV Ab or anti-HIV Ab
- history of gastrointestinal issues or procedures
- history of seizures, diabetes or cancer (except basal cell carcinoma)
- clinically significant cardiovascular, respiratory (except mild asthma), renal, gastrointestinal, hematologic, neurologic, thyroid, or any uncontrolled medical illness or psychiatric disorder
- use of tobacco or nicotine-containing products within the 6-month period prior to study drug administration
- donation or loss of 550mL or more blood volume or receipt of a transfusion of any blood product within 8 weeks prior to study drug administration
- abnormal screening laboratory results that are considered clinically significant by the investigator
- current enrollment in another clinical study
- previous enrollment in this study
- recent (6-month) history of drug/alcohol abuse that could preclude adherence to the protocol
- pregnant or breastfeeding female
- requirement for any OTC and/or prescription medication, vitamins and/or herbal supplements on a regular basis
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT00931281
Start Date
June 1 2009
Last Update
October 13 2010
Active Locations (1)
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1
Site Reference ID/Investigator# 18161
Waukegan, Illinois, United States, 60085