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HealthyPhase 1NCT06619678

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

A Phase 1 study testing MK-8507 and Islatravir in people with Healthy, run by Merck Sharp & Dohme LLC at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 19 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
MK-8507 and Islatravir
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
1 siteUnited States
Study dates
17 Jan 2024to 23 Jun 2024
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Celerion (Site 0001)

    Lincoln, Nebraska, 68502

Other trials in United States

About this study

Official title: 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.

Conditions
Healthy
Being tested
MK-8507, Islatravir

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MK-8507Drug

    Oral administration

  • IslatravirDrug

    Also called ISL, MK-8591

    Oral administration

Study groups in NCT06619678
Study groupRoleWhat they receive
Islatravir+MK-8507ExperimentalPeriod 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.
Receives: Drug: MK-8507; Drug: Islatravir

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of Islatravir Metabolite

    Blood samples will be collected to determine the AUC0-Inf of Islatravir metabolite.

    Measured: At designated timepoints (up to approximately 43 days)

  2. Area Under the Concentration-Time Curve from Time 0 to 168 hours (AUC0-168hrs) of Islatravir Metabolite

    Blood samples will be collected to determine the AUC0-168hrs of Islatravir metabolite.

    Measured: At designated timepoints (up to approximately 168 hours)

  3. Maximum Concentration (Cmax) of Islatravir Metabolite

    Blood samples will be collected to determine Cmax of Islatravir metabolite.

    Measured: At designated timepoints (up to approximately 43 days)

  4. Plasma Concentration at 168 Hours (C168) of Islatravir Metabolite

    Blood samples will be collected to determine the C168 of Islatravir metabolite.

    Measured: At designated timepoints (up to approximately 168 hours)

  5. Time to Maximum Concentration (Tmax) of Islatravir Metabolite

    Blood samples will be collected to determine the Tmax of Islatravir metabolite.

    Measured: At designated timepoints (up to approximately 43 days)

  6. Apparent Terminal Half-life (t1/2) of Islatravir Metabolite

    Blood samples will be collected to determine the t1/2 of Islatravir metabolite.

    Measured: At designated timepoints (up to approximately 43 days)

  7. AUC0-Inf of Islatravir

    Blood samples will be collected to determine the AUC0-Inf of Islatravir.

    Measured: At designated timepoints (up to approximately 22 days)

  8. AUC0-168hrs of Islatravir

    Blood samples will be collected to determine the AUC0-168hrs of Islatravir.

    Measured: At designated timepoints (up to approximately 7 days)

  9. Cmax of Islatravir

    Blood samples will be collected to determine Cmax of Islatravir.

    Measured: At designated timepoints (up to approximately 22 days)

  10. C168 of Islatravir

    Blood samples will be collected to determine the C168 of Islatravir.

    Measured: At designated timepoints (up to approximately 168 hours)

  11. Tmax of Islatravir

    Blood samples will be collected to determine the Tmax of Islatravir.

    Measured: At designated timepoints (up to approximately 22 days)

  12. t1/2 of Islatravir

    Blood samples will be collected to determine the t1/2 of Islatravir.

    Measured: At designated timepoints (up to approximately 22 days)

  13. Apparent clearance (CL/F) of Islatravir

    Blood samples will be collected to determine the CL/F of Islatravir.

    Measured: At designated timepoints (up to approximately 22 days)

  14. Apparent Volume of Distribution During Terminal Phase (Vd/F) of Islatravir

    Blood samples will be collected to determine the Vd/F of Islatravir.

    Measured: At designated timepoints (up to approximately 22 days)

  15. AUC0-168hrs of MK-8507

    Blood samples will be collected to determine the AUC0-168hrs of MK-8507.

    Measured: At designated timepoints (up to approximately 7 days)

  16. Cmax of MK-8507

    Blood samples will be collected to determine Cmax of MK-8507.

    Measured: At designated timepoints (up to approximately 15 days)

  17. C168 of MK-8507

    Blood samples will be collected to determine the C168 of MK-8507.

    Measured: At designated timepoints (up to approximately 168 hours)

  18. Tmax of MK-8507

    Blood samples will be collected to determine the Tmax of MK-8507.

    Measured: At designated timepoints (up to approximately 15 days)

  19. t1/2 of MK-8507

    Blood samples will be collected to determine the t1/2 of MK-8507.

    Measured: At designated timepoints (up to approximately 15 days)

  20. CL/F of MK-8507

    Blood samples will be collected to determine the CL/F of MK-8507.

    Measured: At designated timepoints (up to approximately 15 days)

  21. Vd/F of MK-8507

    Blood samples will be collected to determine the Vd/F of MK-8507.

    Measured: At designated timepoints (up to approximately 15 days)

Secondary outcomes (2)

  1. Number of Participants Who Experience an Adverse Event (AE)

    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.

    Measured: Up to approximately 5 months

  2. Number of Participants Who Discontinue Study Treatment Due to an AE

    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.

    Measured: Up to approximately 5 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Oct 2024
  2. Study start17 Jan 2024
  3. Primary completion23 Jun 2024
  4. Study completion23 Jun 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential
Masking
None (open label)
Enrolment
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06619678
Sponsor's protocol ID
8507-016
Other IDs
MK-8507-016
Status last verified
Sep 2024
First submitted
27 Sep 2024
Last updated
1 Oct 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing MK-8507 and Islatravir in people with Healthy, run by Merck Sharp & Dohme LLC at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). The study lists 21 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06619678.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2024.

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