A Study of the Pharmacokinetic Interaction Between Pirfenidone, Nintedanib, and Nalbuphine Extended Release (NAL ER) in Healthy Participants

Launched by TREVI THERAPEUTICS · Jun 3, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at how a medication called Nalbuphine Extended Release (NAL ER) interacts with two other drugs, pirfenidone and nintedanib, in healthy volunteers. The main goal is to see how these medications affect each other's levels in the body when taken together. This is important to understand because it helps researchers know how safe and effective these drugs are when used in combination.

To participate in this study, you need to be between 18 and 75 years old and have a healthy body weight. You should not have any serious health issues and must pass certain health tests before joining. Unfortunately, if you have a history of drug or alcohol abuse, are a smoker, or have specific health conditions, you may not be eligible. If you decide to participate, you can expect regular check-ups to monitor your health and how your body responds to the medications. This study is not yet open for volunteers, but it aims to provide valuable information about these drugs.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Body mass index (BMI) ≥ 18.0 and ≤ 30.0 kilogram per meter square (kg/m\^2) at Screening.
• • Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs or electrocardiograms (ECGs), as deemed by the principal investigator (PI) or designee.
• Exclusion Criteria:
• • Positive results for coronavirus infection (COVID-19).
• • History or presence of alcohol or drug abuse.
• • Positive urine drug or alcohol results.
• • Smoker who has used nicotine containing products within the last 3 months.
• • History or presence of hypersensitivity or idiosyncratic reaction to the study drugs or related compounds.
• • Hemoglobin, absolute neutrophil count, or platelet levels outside of the reference range at Screening.
• • History of prolonged QT syndrome or a QTc interval.
• • Abnormal liver function at Screening.
• • Positive results for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV).
• • Abnormal Estimated glomerular filtration rate (eGFR).
• • History of difficulty donating blood or donation of blood or plasma within 56 days of Screening.
• • Participation in another clinical study within 30 days of the baseline visit.
• • \[Note: Other inclusion/exclusion criteria mentioned in the protocol may apply.\]