Healthy
Conditions
Brief summary
The goal of this study is to learn what happens to the medication islatravir (ISL), in a healthy person's body over time--called a pharmacokinetic (PK) study. Researchers want to compare the amount of islatravir in the blood when it is taken alone as a single dose and when it is taken with multiple doses of another medication called lamivudine (3TC).
Interventions
DRUGIslatravir (ISL)
Oral administration of a single dose in period 1 and period 2
DRUGLamivudine (3TC)
Oral administration of multiple daily doses for 27 days
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 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
Exclusion criteria
The key
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Peripheral blood mononuclear cell (PBMC) Concentration at 168 hours (C168) of islatravir-triphosphate (ISL-TP ) | Predose and at designated timepoints up to 168 hours post dose | Blood samples will be collected to determine the C168 of ISL-TP |
| PBMC Concentration at 24 Hours (C24) of ISL-TP | Predose and at designated timepoints up to 24 hours post dose | Blood samples will be collected to determine the C24 of ISL-TP |
| PBMC Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-inf) of ISL-TP | Predose and at designated timepoints up to 840 hours post dose | Blood samples will be collected to determine the AUC0-inf of ISL-TP |
| PBMC Area Under the Concentration-time Curve to Time of Last Measurable Concentration (AUClast) of ISL-TP | Predose and at designated time points up to 840 hours post dose | Blood samples will be collected to determine the AUClast of ISL-TP |
| PBMC Maximum Concentration (Cmax) of ISL-TP | Predose and at designated time points up to 840 hours post dose | Blood samples will be collected to determine the Cmax of ISL-TP |
| PBMC Time to Maximum Concentration (Tmax) of ISL-TP | Predose and at designated time points up to 840 hours post dose | Blood samples will be collected to determine the Tmax of ISL-TP |
| PBMC Apparent Terminal Half-life (t1/2) of ISL-TP | Predose and at designated timepoints up to 840 hours post dose | Blood samples will be collected to determine the t1/2 of ISL-TP |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Experience an Adverse Event (AE) | Up to approximately 16 weeks | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who experience an AE will be reported. |
| Plasma C168 of ISL | Predose and at designated timepoints up to 168 hours post dose | Blood samples will be collected to determine the C168 of ISL |
| Number of Participants Who Discontinue Study Treatment Due to an AE | Up to approximately 10 weeks | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who discontinue study treatment due to an AE will be reported |
| Plasma Concentration at 24 Hours (C24) of ISL | Predose and at designated timepoints up to 24 hours post dose | Blood samples will be collected to determine the C24 of ISL |
| Plasma AUC0-inf of ISL | Predose and at designated timepoints up to 168 hours post dose | Blood samples will be collected to determine the AUC0-inf of ISL |
| Plasma AUClast of ISL | Predose and at designated timepoints up to 168 hours post dose | Blood samples will be collected to determine the AUClast of ISL |
| Plasma Cmax of ISL | Predose and at designated timepoints up to 168 hours post dose | Blood samples will be collected to determine the Cmax of ISL |
| Plasma Tmax of ISL | Predose and at designated timepoints up to 168 hours post dose | Blood samples will be collected to determine the Tmax of ISL-TP |
| Plasma t1/2 of ISL | Predose and at designated timepoints up to 168 hours post dose | Blood samples will be collected to determine the t1/2 of ISL |
Countries
United States
Outcome results
None listed