Phase 4
Completed N=12
Analysis of Crushed and Whole Tablet Genvoya
Healthy Volunteers
Source: ClinicalTrials.gov NCT03717129 ↗
Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Jan 2023
Primary outcomePrimary: Area Under the Curve From 0 to Infinity (AUC0-∞) for EVG — 24219; 26948 ng*h/mL
◆ Published Evidence
Not yet cited
0citations
EVG/COBI/FTC/TAF Bioequivalence Comparing Whole Tablets with Tablets Dissolved in Tap Water.
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.
Linked Publications
-
EVG/COBI/FTC/TAF Bioequivalence Comparing Whole Tablets with Tablets Dissolved in Tap Water.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Area Under the Curve From 0 to Infinity (AUC0-∞) for EVG |
24219; 26948 | — |
| PRIMARY AUC0-∞ for COBI |
— | — |
| PRIMARY AUC0-∞ for FTC |
11603; 10969 | — |
| PRIMARY AUC0-∞ for Tenofovir (TFV) |
253; 241 | — |
| SECONDARY EVG Cmax |
1650; 1946 | — |
| SECONDARY FTC Cmax |
2095; 1968 | — |
| SECONDARY TFV Cmax |
11; 9.5 | — |
| SECONDARY EVG Half-life |
5; 5.1 | — |
| SECONDARY COBI Half-life |
— | — |
| SECONDARY FTC Half-life |
15.2; 16.1 | — |
| SECONDARY TFV Half-life |
42.5; 40.7 | — |
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.
Data sourced from ClinicalTrials.gov (NCT03717129) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.