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OpenTrials
Completed

NCT Number: NCT06619678

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

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.

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Key information

Conditions

Healthy

Age range

19 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Celerion (Site 0001)

Lincoln, Nebraska, 68502, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MK-8507

Drug

Oral administration

Islatravir

Drug

Oral administration

Other names: ISL, MK-8591

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. Cmax of Islatravir

    Time frame: At designated timepoints (up to approximately 22 days)

    Blood samples will be collected to determine Cmax of Islatravir.

  10. C168 of Islatravir

    Time frame: At designated timepoints (up to approximately 168 hours)

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

  11. Tmax of Islatravir

    Time frame: At designated timepoints (up to approximately 22 days)

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

  12. 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.

  13. 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.

  14. 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.

  15. 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.

  16. 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.

  17. 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.

  18. 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.

  19. 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.

  20. 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.

  21. 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.

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Oct 1, 2024
Registry last updated
Oct 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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