CompletedPhase 1

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

United States132 participantsStarted 2025-06-30

Plain-language summary

The primary purpose of this study is to evaluate the effect of steady-state NAL ER on the pharmacokinetics (PK) of pirfenidone or nintedanib and the effect of steady-state pirfenidone or nintedanib on the PK of NAL ER in healthy participants.

Who can participate

Age range18 Years – 60 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 or historical or concurrent liver disease. * 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. \[Note: Other inclusion/exclusion criteria mentioned in the protocol may apply.\]

What they're measuring

Maximum Plasma Concentration (Cmax) of NAL ER, Pirfenidone, and Nintedanib

Timeframe: Pre-dose and at multiple timepoints post-dose on Days 1 and 6 for Cohorts A1 and B1; on Days 1 and 8 for Cohort A2; on Days 1 and 7 for Cohort B2

Time to Reach Maximum Observed Concentration (Tmax) of NAL ER, Pirfenidone, and Nintedanib

Timeframe: Pre-dose and at multiple timepoints post-dose on Days 1 and 6 for Cohorts A1 and B1; on Days 1 and 8 for Cohort A2; on Days 1 and 7 for Cohort B2

Area Under the Concentration-Time Curve From Time Zero to Time of Last Measurable Concentration (AUC0-Tlast) of NAL ER, Pirfenidone, and Nintedanib

Timeframe: Pre-dose and at multiple timepoints post-dose on Days 1 and 6 for Cohorts A1 and B1; on Days 1 and 8 for Cohort A2; on Days 1 and 7 for Cohort B2

Area Under the Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of NAL ER, Pirfenidone, and Nintedanib

Timeframe: Pre-dose and at multiple timepoints post-dose on Days 1 and 6 for Cohorts A1 and B1; on Days 1 and 8 for Cohort A2; on Days 1 and 7 for Cohort B2

Apparent Terminal Rate Constant (λz) of NAL ER, Pirfenidone, and Nintedanib

Timeframe: Pre-dose and at multiple timepoints post-dose on Days 1 and 6 for Cohorts A1 and B1; on Days 1 and 8 for Cohort A2; on Days 1 and 7 for Cohort B2

Apparent Terminal Half-Life (t1/2) of NAL ER, Pirfenidone, and Nintedanib

Trial details

NCT IDNCT07015398

SponsorTrevi Therapeutics

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-09-12

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