Study in Healthy Adults to Evaluate the Bioavailability of Two Test Tablet Formulations of ABT-450

Study Overview
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Brief Summary
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The objective of this study is to assess the relative bioavailability of two test tablet formulations of ABT-450 as compared to the ABT-450 hard gelatin capsule formulation as a reference.

Detailed Description
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This is a two part study. Part 1 is a single dose, three period, complete crossover study in approximately 21 subjects. Part 2 is a single dose, two period, complete crossover study in approximately 20 subjects.

Official Title
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An Open-label, Randomized, Crossover Study to Evaluate the Bioavailability of Two Candidate Tablet Formulations of ABT-450 With Reference to the Hard Gelatin Capsule Formulation

Conditions
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Healthy

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Overall healthy subjects Non-childbearing potential females included Exclusion Criteria Positive test for HAV IgM, HBsAg, anti-HCV Ab or anti-HIV Ab 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 Abnormal screening laboratory results that are considered clinically significant by the investigator Pregnant or breastfeeding female; requirement for any OTC and/or prescription medication, vitamins and/or herbal supplements on a regular basis Previous exposure to ABT-450

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

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A<br>Low dose ABT-450 capsule and ritonavir capsules (reference). | Drug: ABT-450<br>* Low dose ABT-450 / ritonavir see Arm Description for more information<br>Drug: ritonavir<br>* ritonavir see Arm Description for more information<br>* Other names: ABT-538, ritonavir, Norvir;|
| Active Comparator: B<br>Low dose ABT-450 SDD Tablet Form 1 and ritonavir capsules (test 1) | Drug: ABT-450<br>* Low dose ABT-450 / ritonavir see Arm Description for more information<br>Drug: ritonavir<br>* ritonavir see Arm Description for more information<br>* Other names: ABT-538, ritonavir, Norvir;|
| Active Comparator: C<br>Low dose ABT-450 SDD Tablet Form 2 and ritonavir capsules (test 2). | Drug: ABT-450<br>* Low dose ABT-450 / ritonavir see Arm Description for more information<br>Drug: ritonavir<br>* ritonavir see Arm Description for more information<br>* Other names: ABT-538, ritonavir, Norvir;|
| Active Comparator: D<br>High dose ABT-450 capsule and ritonavir capsules (reference). | Drug: ritonavir<br>* ritonavir see Arm Description for more information<br>* Other names: ABT-538, ritonavir, Norvir;Drug: ABT-450<br>* High dose ABT-450 / ritonavir See Arm Description for more information<br>|
| Active Comparator: E<br>High dose ABT-450 SDD Tablet Form 1 or 2 and ritonavir capsule (test) | Drug: ritonavir<br>* ritonavir see Arm Description for more information<br>* Other names: ABT-538, ritonavir, Norvir;Drug: ABT-450<br>* High dose ABT-450 / ritonavir See Arm Description for more information<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of Pharmacokinetics of two ABT-450 tablet formulations plus ritonavir and the ABT-450 capsule formulation plus ritonavir. Each dosed at low ABT-450/ritonavir |  | 72 hrs post dose | 
| Assessment of Pharmacokinetics of the selected ABT-450 tablet formulations plus ritonavir and the ABT-450 capsule formulation plus ritonavir. Each dosed at high ABT-450/ritonavir |  | 72 hrs post dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To tabulate treatment emergent adverse events of two ABT-450 tablet formulations plus ritonavir and the ABT-450 capsule formulation plus ritonavir |  | Through 30 days post last dose. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pharmacokinetics, Safety