Status:
COMPLETED
Study in Healthy Adults to Evaluate Effect of Food on 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 effect of food on pharmacokinetics, safety and tolerability of an experimental Hepatitis C Virus (HCV) protease inhibitor with ritonavir in healthy volunte...
Detailed Description
This is an open-label, randomized, 2 cross-over period fasting and non-fasting 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 with the 6-month period prior to study drug administration;
- donation or loss of 550 mL 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 :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT00909311
Start Date
May 1 2009
Last Update
October 13 2010
Active Locations (1)
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1
Site Reference ID/Investigator# 19421
Waukegan, Illinois, United States, 60085