Analysis of Crushed and Whole Tablet Genvoya
Condition: Healthy Volunteers
MeSH terms: Crush Injuries
Intervention: Genvoya Oral dose; Genvoya Crushed Dose
Intervention description: Single Genvoya oral dose directly observed; Single Genvoya crushed tablet in water directly observed
Intervention MeSH terms: Tenofovir; Emtricitabine; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Cobicistat; Emtricitabine tenofovir alafenamide; Elvitegravir, Cobicistat, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Elvitegravir
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Step-wise, two sequential, single-dose, bioequivalence study in 12 healthy volunteers to
      determine whether crushed Genvoya tablet is bioequivalent to whole Genvoya tablet. The first
      study sequence will involve a directly observed single dose of the fixed dose formulation of
      whole Genvoya tablet, with semi-intensive pharmacokinetic serum sampling at time points
      following the dose. After a washout period of seven days, subjects will then receive a
      directly observed single dose of a crushed tablet of Genvoya with subsequent semi-intensive
      pharmacokinetic serum sampling.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy male and female research participants, ≥18 years of age.

          -  Negative HIV-1/2 Ag/Ab serology documented within 30 days prior to study entry.

          -  Negative Hepatitis B surface antigen within 30 days prior to study entry.

          -  Ability and willingness of subject to provide a signed informed consent and comply
             with study requirements.

          -  Negative qualitative urine pregnancy test.

          -  All subjects must not participate purposely in a conception process (e.g., active
             attempt to impregnate, sperm donation, or in vitro fertilization). If participating in
             sexual activity that could lead to pregnancy subjects must take every precaution to
             avoid risk of pregnancy by using a reliable contraception for the duration of the
             study therapy (e.g., condoms, hormonal, barrier).

          -  Laboratory values and physical examination as judged by the principal investigator to
             be safe to participate including normal renal function.

          -  Good peripheral venous access for proposed pharmacokinetic sampling.

          -  Willingness and ability to take oral medications.

        Exclusion Criteria:

          -  History of chronic or acute medical conditions that in the opinion of the investigator
             would jeopardize safety of subjects participating in this study.

          -  Known or suspected hypersensitivity to the components of Genvoya.

          -  Use of prescription or over-the-counter medications, including agents containing
             polyvalent cations (e.g., Mg, Al, Fe, or Ca), or any other drugs that in the opinion
             of the investigator could interfere with the pharmacokinetics of any of the ARV
             components of Genvoya within 2 weeks prior to either study dose.

          -  Pregnant or breast feeding.

          -  Active drug or alcohol use or dependence that, in the opinion of the investigator,
             would interfere with adherence to study requirements.

          -  Hospitalization or therapy for serious illness within 30 days prior to study entry as
             judged by the investigator.

          -  Participation in any investigational drug study within 30 days prior to study entry
             that in the opinion of the investigator would preclude study participation.

          -  Taking any medication listed in the package insert that is contraindicated with
             Genvoya.