A Study of MK-8507 and Islatravir (MK-8591) in Healthy Adult Participants (MK-8507-016)

November 5, 2026 updated by: Merck Sharp & Dohme LLC

An Open-Label Study to Assess the Two-Way Interaction Between Multiple Weekly Doses of MK-8507 and Single Doses of Islatravir (MK-8591) in Healthy Adult Participants

The main goals of this study are to learn what happens to Islatravir or MK-8507 in a person's body over time. Researchers will compare Islatravir given alone to Islatravir given with MK-8507. Researchers will also compare MK-8507 given alone to MK-8507 given with Islatravir.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Nebraska
      • Lincoln, Nebraska, United States, 68502
        • Celerion (Site 0001)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

The key inclusion criteria include but are not limited to the following:

  • Is in good health before randomization
  • Has a body mass index (BMI) ≥18 and ≤32 kg/m^2, inclusive

Exclusion Criteria:

The key exclusion criteria include but are not limited to the following:

  • Has a history of clinically significant endocrine, gastrointestinal (GI), cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases
  • Has a history of cancer with protocol specified exceptions

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Islatravir+MK-8507

Period 1: Participants receive single dose of Islatravir on Day 1. Period 2: Participants receive single dose of MK-8507 on Days 1 and Days 8. Period 3: Participants receive single dose of Islatravir and single dose of MK-8507 on Day 1, 7 days after the Day 8 dose of MK-8507, during Period 2. Participants will receive additional MK-8507 single doses on Days 8, 15, 22, and 29.
Drug: MK-8507

Oral administration

Drug: Islatravir

Oral administration

Other Names:
  • MK-8591
  • ISL

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of Islatravir Metabolite
Time Frame: At designated timepoints (up to approximately 43 days)

Blood samples will be collected to determine the AUC0-Inf of Islatravir metabolite.
At designated timepoints (up to approximately 43 days)
Area Under the Concentration-Time Curve from Time 0 to 168 hours (AUC0-168hrs) of Islatravir Metabolite
Time Frame: At designated timepoints (up to approximately 168 hours)

Blood samples will be collected to determine the AUC0-168hrs of Islatravir metabolite.
At designated timepoints (up to approximately 168 hours)
Maximum Concentration (Cmax) of Islatravir Metabolite
Time Frame: At designated timepoints (up to approximately 43 days)

Blood samples will be collected to determine Cmax of Islatravir metabolite.
At designated timepoints (up to approximately 43 days)
Plasma Concentration at 168 Hours (C168) of Islatravir Metabolite
Time Frame: At designated timepoints (up to approximately 168 hours)

Blood samples will be collected to determine the C168 of Islatravir metabolite.
At designated timepoints (up to approximately 168 hours)
Time to Maximum Concentration (Tmax) of Islatravir Metabolite
Time Frame: At designated timepoints (up to approximately 43 days)

Blood samples will be collected to determine the Tmax of Islatravir metabolite.
At designated timepoints (up to approximately 43 days)
Apparent Terminal Half-life (t1/2) of Islatravir Metabolite
Time Frame: At designated timepoints (up to approximately 43 days)

Blood samples will be collected to determine the t1/2 of Islatravir metabolite.
At designated timepoints (up to approximately 43 days)
AUC0-Inf of Islatravir
Time Frame: At designated timepoints (up to approximately 22 days)

Blood samples will be collected to determine the AUC0-Inf of Islatravir.
At designated timepoints (up to approximately 22 days)
AUC0-168hrs of Islatravir
Time Frame: At designated timepoints (up to approximately 7 days)

Blood samples will be collected to determine the AUC0-168hrs of Islatravir.
At designated timepoints (up to approximately 7 days)
Cmax of Islatravir
Time Frame: At designated timepoints (up to approximately 22 days)

Blood samples will be collected to determine Cmax of Islatravir.
At designated timepoints (up to approximately 22 days)
C168 of Islatravir
Time Frame: At designated timepoints (up to approximately 168 hours)

Blood samples will be collected to determine the C168 of Islatravir.
At designated timepoints (up to approximately 168 hours)
Tmax of Islatravir
Time Frame: At designated timepoints (up to approximately 22 days)

Blood samples will be collected to determine the Tmax of Islatravir.
At designated timepoints (up to approximately 22 days)
t1/2 of Islatravir
Time Frame: At designated timepoints (up to approximately 22 days)

Blood samples will be collected to determine the t1/2 of Islatravir.
At designated timepoints (up to approximately 22 days)
Apparent clearance (CL/F) of Islatravir
Time Frame: At designated timepoints (up to approximately 22 days)

Blood samples will be collected to determine the CL/F of Islatravir.
At designated timepoints (up to approximately 22 days)
Apparent Volume of Distribution During Terminal Phase (Vd/F) of Islatravir
Time Frame: At designated timepoints (up to approximately 22 days)

Blood samples will be collected to determine the Vd/F of Islatravir.
At designated timepoints (up to approximately 22 days)
AUC0-168hrs of MK-8507
Time Frame: At designated timepoints (up to approximately 7 days)

Blood samples will be collected to determine the AUC0-168hrs of MK-8507.
At designated timepoints (up to approximately 7 days)
Cmax of MK-8507
Time Frame: At designated timepoints (up to approximately 15 days)

Blood samples will be collected to determine Cmax of MK-8507.
At designated timepoints (up to approximately 15 days)
C168 of MK-8507
Time Frame: At designated timepoints (up to approximately 168 hours)

Blood samples will be collected to determine the C168 of MK-8507.
At designated timepoints (up to approximately 168 hours)
Tmax of MK-8507
Time Frame: At designated timepoints (up to approximately 15 days)

Blood samples will be collected to determine the Tmax of MK-8507.
At designated timepoints (up to approximately 15 days)
t1/2 of MK-8507
Time Frame: At designated timepoints (up to approximately 15 days)

Blood samples will be collected to determine the t1/2 of MK-8507.
At designated timepoints (up to approximately 15 days)
CL/F of MK-8507
Time Frame: At designated timepoints (up to approximately 15 days)

Blood samples will be collected to determine the CL/F of MK-8507.
At designated timepoints (up to approximately 15 days)
Vd/F of MK-8507
Time Frame: At designated timepoints (up to approximately 15 days)

Blood samples will be collected to determine the Vd/F of MK-8507.
At designated timepoints (up to approximately 15 days)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Who Experience an Adverse Event (AE)
Time Frame: Up to approximately 5 months

An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experience an AE will be reported.
Up to approximately 5 months
Number of Participants Who Discontinue Study Treatment Due to an AE
Time Frame: Up to approximately 5 months

An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who discontinue study treatment due to an AE will be reported.
Up to approximately 5 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Investigators

  • Study Director: Medical Director, Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 17, 2024

Primary Completion (Actual)

June 23, 2024

Study Completion (Actual)

June 23, 2024

Study Registration Dates

First Submitted

September 27, 2024

First Submitted That Met QC Criteria

September 27, 2024

First Posted (Actual)

October 1, 2024

Study Record Updates

Last Update Posted (Actual)

November 10, 2026

Last Update Submitted That Met QC Criteria

November 5, 2026

Last Verified

November 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 8507-016
  • MK-8507-016 (Other Identifier: MSD)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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