A Clinical Study of Islatravir and Its Interaction With Lamivudine (MK-8591-058)

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Islatravir (ISL); Drug: Lamivudine (3TC)

• Registration Number: NCT06811246
• Lead Sponsor: Merck Sharp & Dohme LLC

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2024-02-07
• Primary Completion: 2024-07-14
• Study Completion: 2024-07-14
• Status Verified: 2025-01
• Study First Submitted: 2025-01-31
• Study First Submitted QC: 2025-01-31
• Last Update Submitted: 2025-01-31
• Study First Posted: 2025-02-06
• Last Update Posted: 2025-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ISL and 3TC	Islatravir (ISL)	During period 1, participants receive a single dose of islatravir (ISL). During Period 2, participants receive multiple once-daily doses of lamivudine (3TC) for 27 days, and a single dose of ISL co-administered with 3TC on day 6.
ISL and 3TC	Lamivudine (3TC)	During period 1, participants receive a single dose of islatravir (ISL). During Period 2, participants receive multiple once-daily doses of lamivudine (3TC) for 27 days, and a single dose of ISL co-administered with 3TC on day 6.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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
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.
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

Trial Locations

Locations (1)

Celerion (Site 0001); 🇺🇸 Lincoln, Nebraska, United States