Study in Healthy Adults to Evaluate Effect of Food on Pharmacokinetics, Safety and Tolerability of ABT-450 With Ritonavir

Randomized, Open-label, 2-period Cross-over Study in Healthy Adults to Evaluate the Effect of Food on Pharmacokinetics, Safety and Tolerability of ABT-450 With Ritonavir

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 volunteers.

This is an open-label, randomized, 2 cross-over period fasting and non-fasting study.

Inclusion Criteria:

• overall healthy subjects;
• non-childbearing potential females included

Exclusion Criteria:

• 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