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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)

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ClinicalTrials.gov Identifier: NCT06045507
Recruitment Status : Recruiting
First Posted : September 21, 2023
Last Update Posted : May 6, 2024
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme LLC

Tracking Information
First Submitted Date  ICMJE September 13, 2023
First Posted Date  ICMJE September 21, 2023
Last Update Posted Date May 6, 2024
Actual Study Start Date  ICMJE November 8, 2023
Estimated Primary Completion Date February 18, 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 13, 2023)
  • Number of Participants With ≥1 Adverse Event (AE) [ Time Frame: Up to ~28 weeks ]
    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 [ Time Frame: Up to ~20 weeks ]
    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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 13, 2023)
  • Area Under the Plasma Concentration-Time Curve From Dosing to Last Measurable Concentration (AUC0-last) of MK-8527 [ Time Frame: Day 1: predose and 0.5, 4, and 24 hours postdose. Week 20: 0.5, 4, and 24 hours postdose ]
    The AUC0-last of MK-8527 will be determined.
  • Maximum Plasma Concentration (Cmax) of MK-8527 [ Time Frame: Day 1: predose and 0.5, 4, and 24 hours postdose. Week 20: 0.5, 4, and 24 hours postdose ]
    The Cmax of MK-8527 will be determined.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Pharmacokinetic Study of Oral MK-8527 QM in Participants at Low-Risk for HIV-1 Infection (MK-8527-007)
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Condition  ICMJE
  • HIV
  • HIV Pre-exposure Prophylaxis
Intervention  ICMJE
  • Drug: MK-8527
    MK-8527 capsule
  • Drug: Placebo to MK-8527
    Placebo capsule matched to MK-8527
Study Arms  ICMJE
  • Experimental: MK-8527 Low Dose QM
    Participants receive oral MK-8527 low dose QM for 6 months, followed by an 8-week blinded safety follow-up period.
    Intervention: Drug: MK-8527
  • Experimental: MK-8527 Medium Dose QM
    Participants receive oral MK-8527 medium dose QM for 6 months, followed by an 8-week blinded safety follow-up period.
    Intervention: Drug: MK-8527
  • Experimental: MK-8527 High Dose QM
    Participants receive oral MK-8527 high dose QM for 6 months, followed by an 8-week blinded safety follow-up period.
    Intervention: Drug: MK-8527
  • Placebo Comparator: Placebo to MK-8527
    Participants receive oral placebo matched to MK-8527 QM for 6 months, followed by an 8-week blinded safety follow-up period.
    Intervention: Drug: Placebo to MK-8527
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 13, 2023)		 350
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 18, 2025
Estimated Primary Completion Date February 18, 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Is confirmed HIV-uninfected based on negative HIV-1/HIV-2 test result before randomization
  • Has low-risk of HIV infection
  • Females: is not pregnant or breastfeeding and is either not a participant of childbearing potential (POCBP) OR is a POCBP and uses an acceptable 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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Toll Free Number 1-888-577-8839 Trialsites@merck.com
Listed Location Countries  ICMJE Israel,   South Africa,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT06045507
Other Study ID Numbers  ICMJE 8527-007
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
URL: http://engagezone.msd.com/ds_documentation.php
Current Responsible Party Merck Sharp & Dohme LLC
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Merck Sharp & Dohme LLC
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Director Merck Sharp & Dohme LLC
PRS Account Merck Sharp & Dohme LLC
Verification Date May 2024

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP