Bioequivalence Study of Individual Atazanavir and Cobicistat Compared With Atazanavir in Fixed-dose Combination With Cobicistat
Condition: Human Immunodeficiency Virus Type 1 (HIV-1)
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections
Intervention: Atazanavir; Cobicistat; Atazanavir/Cobicistat FDC
Intervention description: 300-mg capsule; 150-mg tablet; Atazanavir 300-mg/cobicistat 150-mg FDC tablet
Intervention MeSH terms: Atazanavir Sulfate; Cobicistat
Phase: Phase 1
Study type: Interventional
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 64.0
Sex: All
Minimum age: 18 Years
Maximum age: 49 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of the study is to compare the pharmacokinetics and bioequivalence of atazanavir
      in a fixed-dose combination with cobicistat with that of atazanavir coadministered with
      cobicistat as single agents.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Healthy men and women, ages 18 to 49 years

          -  Body mass index 18 to 32 kg/m^2, inclusive

          -  Women of childbearing potential (WOCBP) who were not pregnant or breastfeeding

          -  WOCBP and men who are sexually active with WOCBP must use acceptable contraceptive
             methods

        Key Exclusion Criteria:

          -  Any significant acute or chronic medical illness

          -  Current or recent (within 3 months of study drug administration) gastrointestinal
             tract disease

          -  Any major surgery within 4 weeks of study drug administration

          -  Any gastrointestinal tract surgery (including cholecystectomy) that could have an
             impact on the absorption of study drug

          -  Donation of blood to a blood bank or in a clinical study (except a screening visit)
             within 4 weeks of study drug administration (within 2 weeks for plasma only)

          -  Blood transfusion within 4 weeks of study drug administration

          -  Inability to tolerate oral medication, to be venipunctured, or to tolerate venous
             access

          -  Evidence of organ dysfunction or any clinically significant deviation from normal in
             physical examination or electrocardiogram (ECG) findings, vital sign measurements, or
             results of clinical laboratory tests, beyond what is consistent with the target
             population

          -  Any of the following 12-lead ECG findings prior to study drug administration,
             confirmed by repeat testing

               -  PR ≥210 msec

               -  QRS ≥120 msec

               -  QT ≥500 msec

               -  QTcF ≥450 msec

          -  2nd- or 3rd-degree A-V block or clinically relevant abnormalities in ECG findings

          -  Positive result on urine screening for drugs of abuse

          -  Positive result on blood screening for hepatitis C antibody, hepatitis B surface
             antigen, or HIV-1 or -2 antibody

          -  Laboratory test results indicating levels outside of the ranges specified below:

               -  Alanine aminotransferase >upper limit of normal (ULN)

               -  Aspartate aminotransferase >ULN

               -  Total bilirubin >ULN

               -  Serum creatinine >ULN