Analysis of Crushed and Whole Tablet Genvoya

• Status: Completed
• Trial end date: 2021-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Johns Hopkins University
• Collaborator: Gilead Sciences
• Treatments: Cobicistat; Elvitegravir; Elvitegravir, Cobicistat, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Emtricitabine; Emtricitabine tenofovir alafenamide; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Tenofovir

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.