Clinical trial NCT06619678: A Study of MK-8507 and Islatravir (MK-8591) in Healthy Adult Participants (MK-8507-016)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2024-10-01
Enrollment: 36
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of Islatravir Metabolite
timeFrame: At designated timepoints (up to approximately 43 days)
measure: Area Under the Concentration-Time Curve from Time 0 to 168 hours (AUC0-168hrs) of Islatravir Metabolite
timeFrame: At designated timepoints (up to approximately 168 hours)
measure: Maximum Concentration (Cmax) of Islatravir Metabolite
timeFrame: At designated timepoints (up to approximately 43 days)
measure: Plasma Concentration at 168 Hours (C168) of Islatravir Metabolite
timeFrame: At designated timepoints (up to approximately 168 hours)
measure: Time to Maximum Concentration (Tmax) of Islatravir Metabolite
timeFrame: At designated timepoints (up to approximately 43 days)
measure: Apparent Terminal Half-life (t1/2) of Islatravir Metabolite
timeFrame: At designated timepoints (up to approximately 43 days)
measure: AUC0-Inf of Islatravir
timeFrame: At designated timepoints (up to approximately 22 days)
measure: AUC0-168hrs of Islatravir
timeFrame: At designated timepoints (up to approximately 7 days)
measure: Cmax of Islatravir
timeFrame: At designated timepoints (up to approximately 22 days)
measure: C168 of Islatravir
timeFrame: At designated timepoints (up to approximately 168 hours)
measure: Tmax of Islatravir
timeFrame: At designated timepoints (up to approximately 22 days)
measure: t1/2 of Islatravir
timeFrame: At designated timepoints (up to approximately 22 days)
measure: Apparent clearance (CL/F) of Islatravir
timeFrame: At designated timepoints (up to approximately 22 days)
measure: Apparent Volume of Distribution During Terminal Phase (Vd/F) of Islatravir
timeFrame: At designated timepoints (up to approximately 22 days)
measure: AUC0-168hrs of MK-8507
timeFrame: At designated timepoints (up to approximately 7 days)
measure: Cmax of MK-8507
timeFrame: At designated timepoints (up to approximately 15 days)
measure: C168 of MK-8507
timeFrame: At designated timepoints (up to approximately 168 hours)
measure: Tmax of MK-8507
timeFrame: At designated timepoints (up to approximately 15 days)
measure: t1/2 of MK-8507
timeFrame: At designated timepoints (up to approximately 15 days)
measure: CL/F of MK-8507
timeFrame: At designated timepoints (up to approximately 15 days)
measure: Vd/F of MK-8507
timeFrame: At designated timepoints (up to approximately 15 days)
Secondary outcomes:
measure: Number of Participants Who Experience an Adverse Event (AE)
timeFrame: Up to approximately 5 months
measure: Number of Participants Who Discontinue Study Treatment Due to an AE
timeFrame: Up to approximately 5 months
Other outcomes:
Locations:
city: Lincoln
country: United States
facility: Celerion (Site 0001)
state: Nebraska
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References: