CompletedNCT06619678ClinicalTrials.gov record

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

Healthy

Ask WCR about this study Official registry record ↗

THE QUICK READ

What this study involves

The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.

Study type: Interventional
Phase: Phase 1
Age range: 19 years - 65 years
Sex eligible: All sexes
Healthy volunteers: Accepted
Participants: 36 Actual

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

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.

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

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

Understand screening

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment: Not applicable
Masking: No masking

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 · Drug: Islatravir

MK-8507 DRUG

Oral administration

Islatravir DRUG

Oral administration

Prepare your questions

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

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.

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.

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.

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.

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.

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.

AUC0-Inf of Islatravir