A Study of MK-8507 and Islatravir (MK-8591) in Healthy Adult Participants (MK-8507-016)
- Registration Number
- NCT06619678
- Lead Sponsor
- Merck Sharp & Dohme LLC
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 36
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
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Islatravir+MK-8507 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. Islatravir+MK-8507 Islatravir 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.
- Primary Outcome Measures
Name Time Method Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of Islatravir Metabolite 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 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 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 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 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 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 At designated timepoints (up to approximately 22 days) Blood samples will be collected to determine the AUC0-Inf of Islatravir.
AUC0-168hrs of Islatravir At designated timepoints (up to approximately 7 days) Blood samples will be collected to determine the AUC0-168hrs of Islatravir.
Cmax of Islatravir At designated timepoints (up to approximately 22 days) Blood samples will be collected to determine Cmax of Islatravir.
C168 of Islatravir At designated timepoints (up to approximately 168 hours) Blood samples will be collected to determine the C168 of Islatravir.
Tmax of Islatravir At designated timepoints (up to approximately 22 days) Blood samples will be collected to determine the Tmax of Islatravir.
t1/2 of Islatravir At designated timepoints (up to approximately 22 days) Blood samples will be collected to determine the t1/2 of Islatravir.
Apparent clearance (CL/F) of Islatravir At designated timepoints (up to approximately 22 days) Blood samples will be collected to determine the CL/F of Islatravir.
Apparent Volume of Distribution During Terminal Phase (Vd/F) of Islatravir At designated timepoints (up to approximately 22 days) Blood samples will be collected to determine the Vd/F of Islatravir.
AUC0-168hrs of MK-8507 At designated timepoints (up to approximately 7 days) Blood samples will be collected to determine the AUC0-168hrs of MK-8507.
Cmax of MK-8507 At designated timepoints (up to approximately 15 days) Blood samples will be collected to determine Cmax of MK-8507.
C168 of MK-8507 At designated timepoints (up to approximately 168 hours) Blood samples will be collected to determine the C168 of MK-8507.
Tmax of MK-8507 At designated timepoints (up to approximately 15 days) Blood samples will be collected to determine the Tmax of MK-8507.
t1/2 of MK-8507 At designated timepoints (up to approximately 15 days) Blood samples will be collected to determine the t1/2 of MK-8507.
CL/F of MK-8507 At designated timepoints (up to approximately 15 days) Blood samples will be collected to determine the CL/F of MK-8507.
Vd/F of MK-8507 At designated timepoints (up to approximately 15 days) Blood samples will be collected to determine the Vd/F of MK-8507.
- Secondary Outcome Measures
Name Time Method Number of Participants Who Experience an Adverse Event (AE) 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.
Number of Participants Who Discontinue Study Treatment Due to an AE 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.
Trial Locations
- Locations (1)
Celerion (Site 0001)
🇺🇸Lincoln, Nebraska, United States