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

Study Overview
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Brief Summary
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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.

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

Official Title
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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

Conditions
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HCV Infection

Intervention / Treatment
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* Drug: ABT-450
* Drug: ritonavir


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Non-fasting | Drug: ABT-450<br>* capsules, QD, 1 dose in each cross-over period<br>Drug: ritonavir<br>* capsule, QD, 1 dose in each cross-over period<br>* Other names: Norvir;|
| Active Comparator: 2<br>Fasting | Drug: ABT-450<br>* capsules, QD, 1 dose in each cross-over period<br>Drug: ritonavir<br>* capsule, QD, 1 dose in each cross-over period<br>* Other names: Norvir;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics (blood draws, pre- and post-dose) |  | 17 days | 
| Safety and tolerability (ECGs, AEs, vitals, physical exams, routine labs) |  | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Food effect