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OpenTrials
Completed

NCT Number: NCT06811246

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

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).

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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Celerion (Site 0001)

Lincoln, Nebraska, 68502, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Islatravir (ISL)

Drug

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

Other names: MK-8591, ISL

Lamivudine (3TC)

Drug

Oral administration of multiple daily doses for 27 days

Other names: 3TC

Primary outcomes

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

    Time frame: Predose and at designated timepoints up to 168 hours post dose

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

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

    Time frame: Predose and at designated timepoints up to 24 hours post dose

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

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

    Time frame: Predose and at designated timepoints up to 840 hours post dose

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

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

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

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

  5. PBMC Maximum Concentration (Cmax) of ISL-TP

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

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

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

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

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

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

    Time frame: 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 outcomes

  1. Plasma C168 of ISL

    Time frame: Predose and at designated timepoints up to 168 hours post dose

    Blood samples will be collected to determine the C168 of ISL

  2. Plasma Concentration at 24 Hours (C24) of ISL

    Time frame: Predose and at designated timepoints up to 24 hours post dose

    Blood samples will be collected to determine the C24 of ISL

  3. Plasma AUC0-inf of ISL

    Time frame: Predose and at designated timepoints up to 168 hours post dose

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

  4. Plasma AUClast of ISL

    Time frame: Predose and at designated timepoints up to 168 hours post dose

    Blood samples will be collected to determine the AUClast of ISL

  5. Plasma Cmax of ISL

    Time frame: Predose and at designated timepoints up to 168 hours post dose

    Blood samples will be collected to determine the Cmax of ISL

  6. Plasma Tmax of ISL

    Time frame: Predose and at designated timepoints up to 168 hours post dose

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

  7. Plasma t1/2 of ISL

    Time frame: Predose and at designated timepoints up to 168 hours post dose

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

  8. Number of Participants Who Experience an Adverse Event (AE)

    Time frame: 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.

  9. Number of Participants Who Discontinue Study Treatment Due to an AE

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

An Open-Label Study to Evaluate the Effect of Multiple Doses of Lamivudine on the Single Dose Pharmacokinetics of Islatravir in Healthy Participants

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Feb 6, 2025
Registry last updated
Feb 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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