NCT06811246

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for phase_1 healthy

Timeline
Completed

Started Feb 2024

Typical duration for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 7, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 14, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 14, 2024

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 31, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 6, 2025

Completed
Last Updated

February 6, 2025

Status Verified

January 1, 2025

Enrollment Period

5 months

First QC Date

January 31, 2025

Last Update Submit

January 31, 2025

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

  • +4 more secondary outcomes

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

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Celerion (Site 0001)

Lincoln, Nebraska, 68502, United States

Location

Related Links

MeSH Terms

Interventions

islatravirLamivudine

Intervention Hierarchy (Ancestors)

ZalcitabineDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesDideoxynucleosides

Study Officials

  • Medical DIrector

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR

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

Study Start

February 7, 2024

Primary Completion

July 14, 2024

Study Completion

July 14, 2024

Last Updated

February 6, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will share

http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

More information

Locations

US(1)