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

NCT06811246 | Completed Phase 1 FDA Drug

• 2 other identifiers: 8591-058MK-8591-058
• Study Type: interventional
• Actual enrollment (reported): 20
• Locations: 1 country
• Sites: 1
• Actual (reported): Study Start
• Actual (reported): Primary Completion
• Actual (reported): Study Completion

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).

Conditions

Healthy

Outcome Measures

Primary Outcomes (7)

• Peripheral blood mononuclear cell (PBMC) Concentration at 168 hours (C168) of islatravir-triphosphate (ISL-TP )

  Blood samples will be collected to determine the C168 of ISL-TP

  Predose and at designated timepoints up to 168 hours post dose

• PBMC Concentration at 24 Hours (C24) of ISL-TP

  Blood samples will be collected to determine the C24 of ISL-TP

  Predose and at designated timepoints up to 24 hours post dose

• PBMC Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-inf) of ISL-TP

  Blood samples will be collected to determine the AUC0-inf of ISL-TP

  Predose and at designated timepoints up to 840 hours post dose

• PBMC Area Under the Concentration-time Curve to Time of Last Measurable Concentration (AUClast) of ISL-TP

  Blood samples will be collected to determine the AUClast of ISL-TP

  Predose and at designated time points up to 840 hours post dose

• PBMC Maximum Concentration (Cmax) of ISL-TP

  Blood samples will be collected to determine the Cmax of ISL-TP

  Predose and at designated time points up to 840 hours post dose

• PBMC Time to Maximum Concentration (Tmax) of ISL-TP

  Blood samples will be collected to determine the Tmax of ISL-TP

  Predose and at designated time points up to 840 hours post dose

• PBMC Apparent Terminal Half-life (t1/2) of ISL-TP

  Blood samples will be collected to determine the t1/2 of ISL-TP

  Predose and at designated timepoints up to 840 hours post dose

Secondary Outcomes (9)

• Plasma C168 of ISL

  Predose and at designated timepoints up to 168 hours post dose

• Plasma Concentration at 24 Hours (C24) of ISL

  Predose and at designated timepoints up to 24 hours post dose

• Plasma AUC0-inf of ISL

  Predose and at designated timepoints up to 168 hours post dose

• Plasma AUClast of ISL

  Predose and at designated timepoints up to 168 hours post dose

• Plasma Cmax of ISL

  Predose and at designated timepoints up to 168 hours post dose

Study Arms (1)

ISL and 3TC

EXPERIMENTAL

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.

Drug: Islatravir (ISL); Drug: Lamivudine (3TC)

Interventions

Islatravir (ISL) DRUG

Oral administration of a single dose in period 1 and period 2

Also known as: MK-8591, ISL

ISL and 3TC

Lamivudine (3TC) DRUG

Oral administration of multiple daily doses for 27 days

Also known as: 3TC

ISL and 3TC

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Is in good health before randomization
• Has a body mass index (BMI) ≥18 and ≤32 kg/m\^2

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (1)

Celerion (Site 0001)

Lincoln, Nebraska, 68502, United States

Location

Related Links

• Merck Clinical Trials Information

MeSH Terms

Interventions

islatravir; Lamivudine

Intervention Hierarchy (Ancestors)

Zalcitabine; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Dideoxynucleosides

Study Officials

• Medical DIrector

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Enrollment

20 participants — actual enrollment reported by the registry.

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2025
• First Posted: February 6, 2025
• Last Updated: February 6, 2025

Study Start

February 7, 2024

Actual (reported)

Primary Completion

July 14, 2024

Actual (reported)

Study Completion

July 14, 2024

Actual (reported)

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share

Locations

US (1)