Study in Healthy Adults to Evaluate 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 pharmacokinetics, safety and tolerability of multiple doses of an experimental hepatitis C virus (HCV) protease inhibitor with ritonavir in healthy volunteers.

Detailed Description
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This is a multiple ascending dose, non-fasting, open label, randomized study.

Official Title
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A Blinded, Randomized, Nonfasting, Placebo-Controlled Study in Healthy Adults to Evaluate Safety, Tolerability, and Pharmacokinetic Profiles of Multiple Ascending Doses of ABT-450 With 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 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

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: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>ABT-450/ritonavir | Drug: ABT-450<br>* capsules, QD or BID, 14 days, ascending doses<br>Drug: ritonavir<br>* capsules, QD or BID, 14 days, ascending doses<br>* Other names: Norvir;|
| Placebo Comparator: 2<br>Placebo for ABT-450/placebo for ritonavir | Drug: Placebo for ABT-450<br>* capsule, QD or BID, 14 days<br>* Other names: placebo;Drug: Placebo for ritonavir<br>* capsule, QD or BID, 14 days<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) |  | 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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Multiple Ascending Doses