A Study of Ulonivirine (MK-8507) and Methadone in Healthy Volunteers (MK-8507-019)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Ulonivirine, Methadone.
- Who it may be relevant to
- Registry conditions: Healthy. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Clinical Trial to Study the Effect of a Single Dose of Ulonivirine on the Pharmacokinetics of Methadone
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.
Interventions
- Drug Ulonivirine
Oral Tablet - Drug Methadone
Oral (per local guidelines)
Primary outcome measures
- Dose-Normalized Area Under the Plasma Concentration Time Curve From 0-24 Hours Postdose (AUC0-24) of R-Methadone [Time frame: Up to 24 hours post-dose]
- Dose-Normalized AUC0-24 of S-Methadone [Time frame: Up to 24 hours post-dose]
Secondary outcome measures (12)
- Dose-Normalized Maximum Plasma Concentration (Cmax) of R-Methadone [Time frame: Up to 24 hours post-dose]
- Dose-Normalized Plasma Concentration 24 Hours Postdose (C24) of R-Methadone [Time frame: 24 hours post-dose]
- Time to Maximum Plasma Concentration (Tmax) of R-Methadone [Time frame: Up to 24 hours post-dose]
- Dose-Normalized Cmax of S-Methadone [Time frame: Up to 24 hours post-dose]
- Dose-Normalized C24 of S-Methadone [Time frame: 24 hours post-dose]
- Tmax of S-Methadone [Time frame: Up to 24 hours post-dose]
- Dose-Normalized AUC0-24 of Total Methadone [Time frame: Up to 24 hours post-dose]
- Dose-Normalized Cmax of Total Methadone [Time frame: Up to 24 hours post-dose]
- Dose-Normalized C24 of Total Methadone [Time frame: 24 hours post-dose]
- Tmax of Total Methadone [Time frame: Up to 24 hours post-dose]
- Number of Participants With Adverse Events (AEs) Following Methadone + Ulonivirine Coadministration [Time frame: Up to 16 Days]
- Number of Participants Discontinuing Study Therapy Due to AEs Following Coadministration of Methadone and Ulonivirine [Time frame: Up to 16 Days]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Basic science
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07595263 · 8507-019 · MK-8507-019