Safety, Tolerability and PK Study of Single Doses of ABT-450 With and Without Ritonavir to Treat Hepatitis C Virus (HCV) Genotype 1

Study Overview
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Brief Summary
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The purpose of this study is to determine the pharmacokinetic and safety profiles of an experimental HCV protease inhibitor with and without ritonavir in healthy volunteers.

Official Title
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A Double-Blind, Randomized, Placebo-Controlled, Nonfasting Study in Healthy Adults to Evaluate the Safety, Tolerability, and Pharmacokinetic Profiles of Single Doses of ABT-450 With and Without Ritonavir

Conditions
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HCV Infection

Intervention / Treatment
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* Drug: ABT-450
* Drug: ritonavir
* Drug: placebo for ABT-450
* Drug: Placebo for 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: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>ABT-450 | Drug: ABT-450<br>* capsules,QD, one dose, see Arm Descriptions for more information<br>|
| Placebo Comparator: 2<br>Placebo for ABT-450 | Drug: placebo for ABT-450<br>* capsules, QD, one dose<br>* Other names: placebo;|
| Active Comparator: 3<br>ABT-450/ritonavir | Drug: ABT-450<br>* capsules,QD, one dose, see Arm Descriptions for more information<br>Drug: ritonavir<br>* capsules, QD, one dose, escalating doses, see Arm Descriptions for more information<br>* Other names: Norvir;|
| Placebo Comparator: 4<br>Placebo for ABT-450/placebo for ritonavir | Drug: placebo for ABT-450<br>* capsules, QD, one dose<br>* Other names: placebo;Drug: Placebo for ritonavir<br>* capsules, QD, one dose<br>* Other names: placebo;|

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) |  | 4 days | 
| Safety and Tolerability (ECGs, AEs, vitals, physical exams, routine labs) |  | 10 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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FIH, SAD