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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-07

Study Completion Date

2024-07-14

Brief Summary

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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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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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ISL and 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.

Group Type EXPERIMENTAL

Islatravir (ISL)

Intervention Type DRUG

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

Lamivudine (3TC)

Intervention Type DRUG

Oral administration of multiple daily doses for 27 days

Interventions

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Islatravir (ISL)

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

Intervention Type DRUG

Lamivudine (3TC)

Oral administration of multiple daily doses for 27 days

Intervention Type DRUG

Other Intervention Names

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MK-8591 ISL 3TC

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes