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Analysis of Crushed and Whole Tablet Genvoya

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03717129
Recruitment Status : Completed
First Posted : October 24, 2018
Last Update Posted : March 24, 2020
Sponsor:
Collaborator:
Gilead Sciences
Information provided by (Responsible Party):
Johns Hopkins University

Brief 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.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: Genvoya Oral dose Drug: Genvoya Crushed Dose Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Analysis of Crushed and Whole Tablet Genvoya
Actual Study Start Date : April 15, 2019
Actual Primary Completion Date : February 15, 2020
Actual Study Completion Date : February 29, 2020

Arm Intervention/treatment
Active Comparator: Genvoya Oral dose
Single observed oral dose of Genvoya whole tablet
Drug: Genvoya Oral dose
Single Genvoya oral dose directly observed
Other Name: elvitegravir/cobicistat/emtricitabine/ tenofovir alafenamide

Experimental: Genvoya Crushed Dose
Single observed oral dose of Genvoya crushed tablet
Drug: Genvoya Crushed Dose
Single Genvoya crushed tablet in water directly observed
Other Name: elvitegravir/cobicistat/emtricitabine/ tenofovir alafenamide




Primary Outcome Measures :
  1. Area Under the Curve from 0 to infinity (AUC0-∞) for EVG [ Time Frame: 72 hours ]
    AUC 0 to Infinity for Elvitegravir (mg-hr/mL)

  2. AUC0-∞ for COBI [ Time Frame: 72 hours ]
    AUC 0 to Infinity for Cobicistat (mg-hr/mL)

  3. AUC0-∞ for FTC [ Time Frame: 72 hours ]
    AUC 0 to Infinity for Emtricitabine (mg-hr/mL)

  4. AUC0-∞ for Tenofovir (TFV) [ Time Frame: 72 hours ]
    AUC 0 to Infinity for TFV (mg-hr/mL)


Secondary Outcome Measures :
  1. EVG Half-life [ Time Frame: 72 hours ]
    Terminal elimination half-life for EVG (hours)

  2. COBI Half-life [ Time Frame: 72 hours ]
    Terminal elimination half-life for COBI (hours)

  3. FTC Half-life [ Time Frame: 72 hours ]
    Terminal elimination half-life for FTC (hours)

  4. TFV Half-life [ Time Frame: 72 hours ]
    Terminal elimination half-life for TFV (hours)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03717129


Locations
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United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21205
Sponsors and Collaborators
Johns Hopkins University
Gilead Sciences
Investigators
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Principal Investigator: Craig Hendrix, MD JHU

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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT03717129    
Other Study ID Numbers: IRB00110315
IN-US-292-4089 ( Other Grant/Funding Number: Gilead )
First Posted: October 24, 2018    Key Record Dates
Last Update Posted: March 24, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Crush Injuries
Wounds and Injuries
Tenofovir
Emtricitabine
Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
Cobicistat
Genvoya
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Anti-HIV Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors