A Study of Ulonivirine (MK-8507) and Methadone in Healthy Volunteers (MK-8507-019)

Phase 1RecruitingNCT07595263

Merck Sharp & Dohme LLC14 enrolled

Overview

This study is designed to determine the effect of ulonivirine (MK-8507) on methadone in the body. Participants will take methadone alone and then methadone with ulonivirine to see if ulonivirine changes how the body processes methadone.

Study Type

INTERVENTIONAL

Allocation

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

UlonivirineDRUG

Oral Tablet

MethadoneDRUG

Oral (per local guidelines)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria The main Inclusion Criteria include but are not limited to: * Is in good health * Has a body mass index (BMI) between \>18 and ≤40 kg/m\^2 * Is reliably participating in a methadone maintenance program for at least 2 months prior to Day 1 and is on a documented stable dose of methadone for at least 14 days prior to Day 1 Exclusion Criteria The main Exclusion Criteria include but are not limited to: * Has a history of cancer (malignancy) * Has a history of significant multiple and/or severe allergies, or has had an anaphylactic reaction or significant intolerability to prescription or nonprescription drugs or food * Has tested positive human immunodeficiency virus (HIV) or for a sexually transmitted infection at screening * Is under the age of legal consent

Locations (1)

Pinnacle Research Group ( Site 0002)

Anniston, Alabama, United States

RECRUITING

Outcomes

Primary Outcomes

Dose-Normalized Area Under the Plasma Concentration Time Curve From 0-24 Hours Postdose (AUC0-24) of R-Methadone

The AUC0-24 of R-methadone will be determined on Day 1 (methadone) and Day 2 (methadone + ulonivirine).