Healthy
Conditions
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.
Interventions
DRUGMK-8507
Oral administration
DRUGIslatravir
Oral administration
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Countries
United States
Outcome results
None listed