Drug Interaction Study With Proton Pump Inhibitor

Study Overview
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Brief Summary
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The purpose of this clinical research study is to assess the effect of omeprazole at 20 mg on the pharmacokinetics of atazanavir administered as atazanavir with ritonavir relative to atazanavir or atazanavir/ritonavir in the absence of omeprazole in healthy subjects.

Official Title
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Randomized, Open-Label, Multiple-Dose Study to Evaluate the Effect of Omeprazole 20 mg on the Pharmacokinetics of Atazanavir Administered With Ritonavir in Healthy Subjects

Conditions
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HIV Infections

Intervention / Treatment
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* Drug: Atazanavir
* Drug: Atazanavir/Ritonavir
* Drug: Atazanavir/Ritonavir+Omeprazole
* Drug: Atazanavir/Ritonavir+Omeprazole
* Drug: Atazanavir
* Drug: Atazanavir/Ritonavir
* Drug: Atazanavir/Ritonavir+Omeprazole
* Drug: Atazanavir/Ritonavir+Omeprazole


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male and female subjects between the ages of 18 to 50 years old with BMI 18 to 32 kg/m2

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A1<br> | Drug: Atazanavir<br>* Capsules, Oral, 400 mg, once daily, 6 days.<br>* Other names: Reyataz;|
| Active Comparator: A2<br> | Drug: Atazanavir/Ritonavir<br>* Capsules/capsules, Oral, 300/100 mg, once daily, 10 days.<br>* Other names: Reyataz;|
| Experimental: A3 I<br> | Drug: Atazanavir/Ritonavir+Omeprazole<br>* Capsules/capsules + Capsules, Oral, 300/100 mg + 20 mg, once daily in PM + once daily in AM, 7 days.<br>* Other names: Reyataz;|
| Experimental: A3 II<br> | Drug: Atazanavir/Ritonavir+Omeprazole<br>* Capsules/capsules + Capsules, Oral, 400/100 mg + 20 mg, once daily in PM + once daily in AM, 7 days.<br>* Other names: Reyataz;|
| Active Comparator: B1<br> | Drug: Atazanavir<br>* Capsules, Oral, 400 mg, once daily, 6 days.<br>* Other names: Reyataz;|
| Active Comparator: B2<br> | Drug: Atazanavir/Ritonavir<br>* Capsules/capsules, Oral, 300/100 mg, once daily, 10 days.<br>* Other names: Reyataz;|
| Experimental: B3 I<br> | Drug: Atazanavir/Ritonavir+Omeprazole<br>* Capsules/capsules + Capsules, Oral, 400/100 mg + 20 mg, once daily in AM + once daily in AM, 7 days.<br>* Other names: Reyataz;|
| Experimental: B3 II<br> | Drug: Atazanavir/Ritonavir+Omeprazole<br>* Capsules/capsules + Capsules, Oral, 400/100 mg + 20 mg, once daily in AM + once daily in PM, 7 days.<br>* Other names: Reyataz;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of omeprazole 20 mg on PK of atazanavir (with ritonavir), coadministered or temporally separated, in healthy subjects. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PK of ritonavir and omeprazole. Safety and tolerability of atazanavir +/- ritonavir, +/- omeprazole. |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Protease inhibitor