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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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HIV, HIV Pre-exposure Prophylaxis

Intervention / Treatment
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* Drug: MK-8527
* Drug: Placebo to MK-8527


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MK-8527 Low Dose QM<br>Participants receive oral MK-8527 low dose QM for 6 months, followed by an 8-week blinded safety follow-up period. | Drug: MK-8527<br>* MK-8527 capsule<br>|
| Experimental: MK-8527 Medium Dose QM<br>Participants receive oral MK-8527 medium dose QM for 6 months, followed by an 8-week blinded safety follow-up period. | Drug: MK-8527<br>* MK-8527 capsule<br>|
| Experimental: MK-8527 High Dose QM<br>Participants receive oral MK-8527 high dose QM for 6 months, followed by an 8-week blinded safety follow-up period. | Drug: MK-8527<br>* MK-8527 capsule<br>|
| Placebo Comparator: Placebo to MK-8527<br>Participants receive oral placebo matched to MK-8527 QM for 6 months, followed by an 8-week blinded safety follow-up period. | Drug: Placebo to MK-8527<br>* Placebo capsule matched to MK-8527<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Up to  28 weeks | 
| 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. | Up to  20 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Day 1: predose and 0.5, 4, and 24 hours postdose. Week 20: 0.5, 4, and 24 hours postdose | 
| Maximum Plasma Concentration (Cmax) of MK-8527 | The Cmax of MK-8527 will be determined. | Day 1: predose and 0.5, 4, and 24 hours postdose. Week 20: 0.5, 4, and 24 hours postdose |