HealthyHealthy volunteersDrugPhase 1
What this study is
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.
What's being tested
- Ulonivirine
Intervention · DRUG
Oral Tablet
- Methadone
Intervention · DRUG
Oral (per local guidelines)
Study details
- Official title
- A Clinical Trial to Study the Effect of a Single Dose of Ulonivirine on the Pharmacokinetics of Methadone
- Sponsor
- Merck Sharp & Dohme LLC
- Conditions
- Healthy
- Enrolling
- 14 people
- Starts
- 2026-08-17
- Est. completion
- 2027-01-15
- Design
- Open-label, single group, Phase 1
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 65 YearsSex ALLHealthy volunteers AcceptedYou may qualify if
- 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
You can't join if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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1
Study locations (1)
1 openPinnacle Research Group ( Site 0002)
Anniston, Alabama, United States
- Study Coordinator · Contact256-236-0055
Recruiting
Study team
Sponsor
Merck Sharp & Dohme LLC
Study ID 8507-019
Study director
Medical Director
Merck Sharp & Dohme LLC
Have questions? The contacts above can answer them before you apply.
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.