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Safety and Pharmacokinetic Study of Oral MK-8527 QM in Participants at Low-Risk for HIV-1 Infection (MK-8527-007)

Primary Purpose

HIV, HIV Pre-exposure Prophylaxis

Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
MK-8527
Placebo to MK-8527
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for HIV

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Is confirmed HIV-uninfected based on negative HIV-1/HIV-2 test result before randomization Has low-risk of HIV infection Males: if capable of producing sperm, the participant agrees to the following during the intervention period and for ≥8 weeks after the last dose of study intervention: abstains from penile-vaginal intercourse OR uses approved contraception unless confirmed to be azoospermic. Females: is not pregnant or breastfeeding and is either not a participant of childbearing potential (POCBP) OR is a POCBP and uses highly effective contraception or is abstinent from penile-vaginal intercourse Exclusion Criteria: Has hypersensitivity or other contraindication to any of the components of the study interventions as determined by the investigator Has an active diagnosis of hepatitis due to any cause, including active hepatitis B (HBV) infection (defined as HBsAg-positive) or hepatitis C virus (HCV) infection (defined as detectable HCV ribonucleic acid [RNA]) Prior use of MK-8527 or islatravir (MK-8591)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Experimental

    Experimental

    Placebo Comparator

    Arm Label

    MK-8527 Low Dose QM

    MK-8527 Medium Dose QM

    MK-8527 High Dose QM

    Placebo to MK-8527

    Arm Description

    Participants receive oral MK-8527 low dose QM for 6 months, followed by an 8-week blinded safety follow-up period.

    Participants receive oral MK-8527 medium dose QM for 6 months, followed by an 8-week blinded safety follow-up period.

    Participants receive oral MK-8527 high dose QM for 6 months, followed by an 8-week blinded safety follow-up period.

    Participants receive oral placebo matched to MK-8527 QM for 6 months, followed by an 8-week blinded safety follow-up period.

    Outcomes

    Primary Outcome Measures

    Number of Participants With ≥1 Adverse Event (AE)
    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
    Number of Participants Discontinuing From Study Therapy Due to AE
    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.

    Secondary Outcome Measures

    Area Under the Plasma Concentration-Time Curve From Dosing to Last Measurable Concentration (AUC0-last) of MK-8527
    The AUC0-last of MK-8527 will be determined.
    Maximum Plasma Concentration (Cmax) of MK-8527
    The Cmax of MK-8527 will be determined.

    Full Information

    First Posted
    September 13, 2023
    Last Updated
    September 21, 2023
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06045507
    Brief Title
    Safety and Pharmacokinetic Study of Oral MK-8527 QM in Participants at Low-Risk for HIV-1 Infection (MK-8527-007)
    Official Title
    A Phase 2a, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Oral MK-8527 Once Monthly in Participants at Low-Risk for HIV-1 Infection
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    November 12, 2023 (Anticipated)
    Primary Completion Date
    February 18, 2025 (Anticipated)
    Study Completion Date
    February 18, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Merck Sharp & Dohme LLC

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    This double-blind, placebo-controlled study is designed to assess the safety, tolerability, and pharmacokinetics of oral MK-8527 taken once monthly (QM) in participants at low risk for human immunodeficiency virus Type 1 (HIV-1) infection.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    HIV, HIV Pre-exposure Prophylaxis

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    350 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    MK-8527 Low Dose QM
    Arm Type
    Experimental
    Arm Description
    Participants receive oral MK-8527 low dose QM for 6 months, followed by an 8-week blinded safety follow-up period.
    Arm Title
    MK-8527 Medium Dose QM
    Arm Type
    Experimental
    Arm Description
    Participants receive oral MK-8527 medium dose QM for 6 months, followed by an 8-week blinded safety follow-up period.
    Arm Title
    MK-8527 High Dose QM
    Arm Type
    Experimental
    Arm Description
    Participants receive oral MK-8527 high dose QM for 6 months, followed by an 8-week blinded safety follow-up period.
    Arm Title
    Placebo to MK-8527
    Arm Type
    Placebo Comparator
    Arm Description
    Participants receive oral placebo matched to MK-8527 QM for 6 months, followed by an 8-week blinded safety follow-up period.
    Intervention Type
    Drug
    Intervention Name(s)
    MK-8527
    Intervention Description
    MK-8527 capsule
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo to MK-8527
    Intervention Description
    Placebo capsule matched to MK-8527
    Primary Outcome Measure Information:
    Title
    Number of Participants With ≥1 Adverse Event (AE)
    Description
    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
    Time Frame
    Up to ~28 weeks
    Title
    Number of Participants Discontinuing From Study Therapy Due to AE
    Description
    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
    Time Frame
    Up to ~20 weeks
    Secondary Outcome Measure Information:
    Title
    Area Under the Plasma Concentration-Time Curve From Dosing to Last Measurable Concentration (AUC0-last) of MK-8527
    Description
    The AUC0-last of MK-8527 will be determined.
    Time Frame
    Day 1: predose and 0.5, 4, and 24 hours postdose. Week 20: 0.5, 4, and 24 hours postdose
    Title
    Maximum Plasma Concentration (Cmax) of MK-8527
    Description
    The Cmax of MK-8527 will be determined.
    Time Frame
    Day 1: predose and 0.5, 4, and 24 hours postdose. Week 20: 0.5, 4, and 24 hours postdose

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Is confirmed HIV-uninfected based on negative HIV-1/HIV-2 test result before randomization Has low-risk of HIV infection Males: if capable of producing sperm, the participant agrees to the following during the intervention period and for ≥8 weeks after the last dose of study intervention: abstains from penile-vaginal intercourse OR uses approved contraception unless confirmed to be azoospermic. Females: is not pregnant or breastfeeding and is either not a participant of childbearing potential (POCBP) OR is a POCBP and uses highly effective contraception or is abstinent from penile-vaginal intercourse Exclusion Criteria: Has hypersensitivity or other contraindication to any of the components of the study interventions as determined by the investigator Has an active diagnosis of hepatitis due to any cause, including active hepatitis B (HBV) infection (defined as HBsAg-positive) or hepatitis C virus (HCV) infection (defined as detectable HCV ribonucleic acid [RNA]) Prior use of MK-8527 or islatravir (MK-8591)
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Medical Director
    Organizational Affiliation
    Merck Sharp & Dohme LLC
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
    IPD Sharing URL
    http://engagezone.msd.com/ds_documentation.php
    Links:
    URL
    http://www.merckclinicaltrials.com
    Description
    Merck Clinical Trials Information

    Learn more about this trial

    Safety and Pharmacokinetic Study of Oral MK-8527 QM in Participants at Low-Risk for HIV-1 Infection (MK-8527-007)

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