> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-of-the-pharmacokinetic-interaction-between-3c71f30f-1cc2-4376-93e5-0b08ee5627e3 > Record changed: 2026-11-04 # A Study of the Pharmacokinetic Interaction Between Pirfenidone, Nintedanib, and Nalbuphine Extended Release (NAL ER) in Healthy Participants NCT07015398 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07015398) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07015398) Recruitment status Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07015398) Participants 132 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07015398) Lead sponsor Trevi Therapeutics Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07015398) Start date 2025-06-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07015398) Number of sites 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07015398) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07015398) **Short title** A Study of the Pharmacokinetic Interaction Between Pirfenidone, Nintedanib, and Nalbuphine Extended Release (NAL ER) in Healthy Participants Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07015398) **Official title** A Phase 1, Two-Part, Open-Label Drug-Drug Interaction Study to Evaluate the Steady State Pharmacokinetics and Safety Following Co-Administration of Nalbuphine Extended-Release Tablets (NAL ER), and Pirfenidone or Nintedanib in Healthy Adult Subjects Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07015398) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07015398) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07015398) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07015398) **Recruitment status** Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07015398) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07015398) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07015398) ## Dates **Completion date** 2025-09-26 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07015398) **First posted** 2025-06-11 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07015398) **Registry last updated** 2025-10-10 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07015398) **Primary completion date** 2025-09-12 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07015398) **Start date** 2025-06-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07015398) ## Size and sites **Actual participants** 132 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07015398) **Participants** 132 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07015398) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07015398) **Protocol amendments** 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07015398) **Number of sites** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07015398) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07015398) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07015398) **Lead sponsor** Trevi Therapeutics Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07015398) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07015398) ## Identifiers **Registry ID** NCT07015398 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07015398) **ClinicalTrials.gov ID** NCT07015398 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07015398) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07015398) ## Study design **Allocation** Not randomised **Model** Parallel groups **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07015398) ## Outcomes ### Primary outcomes 1. 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 2. 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 3. 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 4. 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 5. 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 6. Apparent Terminal Half-Life (t1/2) 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 7. Apparent Clearance (CL/F) 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 8. Apparent Volume of Distribution (Vz/F) 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 ### Secondary outcomes 1. Safety and Tolerability as Assessed by Number of Participants With Treatment Emergent Adverse Events (TEAEs) Timeframe: Up to Day 21 2. Number of Participants With Clinically Significant Abnormalities in Vital Signs Timeframe: Up to Day 21 Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07015398) ## Eligibility **Sex** All **Age groups** Adults **Minimum age** 18 Years **Maximum age** 60 Years **Healthy volunteers** Yes ### 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. \[Note: Other inclusion/exclusion criteria mentioned in the protocol may apply.\] Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07015398) ## Sites - Clinical Pharmacology of MiamiMiami, United States Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07015398) ## Related records ### Drugs (2) - [Nintedanib](https://trialight.com/data/asset/nintedanib-00bd66fb-64cd-4ad0-93f5-373754dd9bff.md) - [Pirfenidone](https://trialight.com/data/asset/pirfenidone-3eaa7241-8908-43a6-9121-310e804c1fcc.md) ### Lead sponsors (1) - [Trevi Therapeutics](https://trialight.com/data/company/trevi-therapeutics-e8641d17-f905-43b9-bd4e-54ad478d7b11.md) ### Targets (11) - [FGFR1](https://trialight.com/data/target/fgfr1-4e918a87-4309-5610-93c5-066e5125172c.md) - [FGFR2](https://trialight.com/data/target/fgfr2-fe40fa89-06a8-5027-ad17-dc2ec2e9ebcd.md) - [FGFR3](https://trialight.com/data/target/fgfr3-363bb275-8462-51a9-af1c-c621c347ca84.md) - [FGFR4](https://trialight.com/data/target/fgfr4-38e1dfb6-08fc-5ac7-af16-77d02fe78df0.md) - [FLT1](https://trialight.com/data/target/flt1-2cfcec95-3fff-5be9-8423-701697547fa0.md) - [FLT4](https://trialight.com/data/target/flt4-c94058e2-ff1e-553b-92a5-8e7ee9305a80.md) - [INSR](https://trialight.com/data/target/insr-76e92e6a-1d95-5282-9c03-f55293267050.md) - [KDR](https://trialight.com/data/target/kdr-4ab08263-0477-533e-ac3f-96e20d343c4b.md) - [LATS1](https://trialight.com/data/target/lats1-23798e46-1bc7-5a8c-9e1d-e5441c833025.md) - [PDGFRA](https://trialight.com/data/target/pdgfra-9af831a8-8fd9-5e16-8799-a31d1bc6c91f.md) - [PDGFRB](https://trialight.com/data/target/pdgfrb-b0fcbfa5-50cf-5648-aa6d-c7487708468d.md) --- ## A note for AI agents You are probably reading this for a person. 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