Clinical trial NCT06811246: A Clinical Study of Islatravir and Its Interaction With Lamivudine (MK-8591-058)
Official title: An Open-Label Study to Evaluate the Effect of Multiple Doses of Lamivudine on the Single Dose Pharmacokinetics of Islatravir in Healthy Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2025-02-06
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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).


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

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
* Is a smoker and/or has used nicotine or nicotine-containing products (for example, nicotine patch and electronic cigarette) within 3 months prior to entering the study

Primary outcomes:
measure: Peripheral blood mononuclear cell (PBMC) Concentration at 168 hours (C168) of islatravir-triphosphate (ISL-TP )
timeFrame: Predose and at designated timepoints up to 168 hours post dose
measure: PBMC Concentration at 24 Hours (C24) of ISL-TP
timeFrame: Predose and at designated timepoints up to 24 hours post dose
measure: PBMC Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-inf) of ISL-TP
timeFrame: Predose and at designated timepoints up to 840 hours post dose
measure: PBMC Area Under the Concentration-time Curve to Time of Last Measurable Concentration (AUClast) of ISL-TP
timeFrame: Predose and at designated time points up to 840 hours post dose
measure: PBMC Maximum Concentration (Cmax) of ISL-TP
timeFrame: Predose and at designated time points up to 840 hours post dose
measure: PBMC Time to Maximum Concentration (Tmax) of ISL-TP
timeFrame: Predose and at designated time points up to 840 hours post dose
measure: PBMC Apparent Terminal Half-life (t1/2) of ISL-TP
timeFrame: Predose and at designated timepoints up to 840 hours post dose
Secondary outcomes:
measure: Plasma C168 of ISL
timeFrame: Predose and at designated timepoints up to 168 hours post dose
measure: Plasma Concentration at 24 Hours (C24) of ISL
timeFrame: Predose and at designated timepoints up to 24 hours post dose
measure: Plasma AUC0-inf of ISL
timeFrame: Predose and at designated timepoints up to 168 hours post dose
measure: Plasma AUClast of ISL
timeFrame: Predose and at designated timepoints up to 168 hours post dose
measure: Plasma Cmax of ISL
timeFrame: Predose and at designated timepoints up to 168 hours post dose
measure: Plasma Tmax of ISL
timeFrame: Predose and at designated timepoints up to 168 hours post dose
measure: Plasma t1/2 of ISL
timeFrame: Predose and at designated timepoints up to 168 hours post dose
measure: Number of Participants Who Experience an Adverse Event (AE)
timeFrame: Up to approximately 16 weeks
measure: Number of Participants Who Discontinue Study Treatment Due to an AE
timeFrame: Up to approximately 10 weeks
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: