Drug Interaction Study With Famotidine, Atazanavir, and Atazanavir/Ritonavir/Tenofovir

Study Overview
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Brief Summary
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The purpose of this clinical research study is to assess the pharmacokinetics of atazanavir, identifying one or more dosing regimens of atazanavir/ritonavir/tenofovir when dosed with famotidine results in atazanavir exposures similar to those when atazanavir/ritonavir/tenofovir 300/100/300 mg is dosed without famotidine in healthy subjects.

Official Title
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Randomized, Open-Label, Multiple-Dose Study to Evaluate the Effect of Famotidine on the Pharmacokinetics of Atazanavir/Ritonavir/Tenofovir in Healthy Subjects

Conditions
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HIV Infections

Intervention / Treatment
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* Drug: Atazanavir+Ritonavir+Tenofovir
* Drug: Atazanavir+Ritonavir+Tenofovir+Famotidine
* Drug: Atazanavir+Ritonavir+Tenofovir+Famotidine
* Drug: Atazanavir+Ritonavir+Tenofovir+Famotidine
* Drug: Atazanavir+Ritonavir+Tenofovir+Famotidine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male and female subjects between the ages 18 to 50 years old with a 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: A<br> | Drug: Atazanavir+Ritonavir+Tenofovir<br>* Cap/Cap/Tablet, Oral, 300/100/300 mg, QAM/QAM/QAM, 10 days.<br>* Other names: Abilify;|
| Experimental: B<br> | Drug: Atazanavir+Ritonavir+Tenofovir+Famotidine<br>* Cap/Cap/Tablet/Tablet, Oral, 300/100/300/20 mg, QAM/QAM/QAM/Q12 coadmin, 7 days.<br>* Other names: Abilify;|
| Experimental: C<br> | Drug: Atazanavir+Ritonavir+Tenofovir+Famotidine<br>* Cap/Cap/Tablet/Tablet, Oral, 300/100/300/20 mg, QAM/QAM/QAM/Q12 2 hr post, 7 days.<br>* Other names: Abilify;|
| Experimental: D<br> | Drug: Atazanavir+Ritonavir+Tenofovir+Famotidine<br>* Cap/Cap/Tablet/Tablet, Oral, 300/100/300/40 mg, QAM/QAM/QAM/QPM 12 hr post, 7 days.<br>* Other names: Abilify;|
| Experimental: E<br> | Drug: Atazanavir+Ritonavir+Tenofovir+Famotidine<br>* Cap/Cap/Tablet/Tablet, Oral, 300/100/300/40 mg, QAM/QAM/QAM/Q12 2 hr post,7 days.<br>* Other names: Abilify;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess PK of ATV, identifying dosing regimens of ATV/RTV/TDF when dosed with FAM that result in ATV exposures similar to ATV/RTV/TDF 300/100/300 mg with and without FAM. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess PK , safety, and tolerability of ATV/RTV/TDF with and without FAM. |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV, Protease Inhibitor