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

NCT06619678 | Completed Phase 1 FDA Drug

• 2 other identifiers: 8507-016MK-8507-016
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (21)

• 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.

  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

  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

  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

  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

  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

  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

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

  At designated timepoints (up to approximately 22 days)

• AUC0-168hrs of Islatravir

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

  At designated timepoints (up to approximately 7 days)

• Cmax of Islatravir

  Blood samples will be collected to determine Cmax of Islatravir.

  At designated timepoints (up to approximately 22 days)

• C168 of Islatravir

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

  At designated timepoints (up to approximately 168 hours)

• Tmax of Islatravir

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

  At designated timepoints (up to approximately 22 days)

• t1/2 of Islatravir

  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

  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

  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

  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

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

  At designated timepoints (up to approximately 15 days)

• C168 of MK-8507

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

  At designated timepoints (up to approximately 168 hours)

• Tmax of MK-8507

  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

  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

  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

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

  At designated timepoints (up to approximately 15 days)

Secondary Outcomes (2)

• Number of Participants Who Experience an Adverse Event (AE)

  Up to approximately 5 months

• Number of Participants Who Discontinue Study Treatment Due to an AE

  Up to approximately 5 months

Study Arms (1)

Islatravir+MK-8507

EXPERIMENTAL

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; Drug: Islatravir

Interventions

MK-8507 DRUG

Oral administration

Islatravir+MK-8507

Islatravir DRUG

Oral administration

Also known as: ISL, MK-8591

Islatravir+MK-8507

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (1)

Celerion (Site 0001)

Lincoln, Nebraska, 68502, United States

Location

Related Links

• Merck Clinical Trials Information

MeSH Terms

Interventions

ulonivirine; islatravir

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2024
• First Posted: October 1, 2024
• Study Start: January 17, 2024
• Primary Completion: June 23, 2024
• Study Completion: June 23, 2024
• Last Updated: October 1, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share

Locations

US (1)