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

Phase 1

Recruiting

• Conditions: Healthy Participants
• Interventions: Drug: NAL ER; Drug: Pirfenidone; Drug: Nintedanib

• Registration Number: NCT07015398
• Lead Sponsor: Trevi Therapeutics

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-06-03
• Study First Submitted QC: 2025-06-03
• Study First Posted: 2025-06-11
• Study Start: 2025-06-30
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-16
• Last Update Posted: 2025-07-20
• Primary Completion: 2025-09
• Study Completion: 2025-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 130

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.]

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort A1 - NAL ER + Pirfenidone	NAL ER	Participants will receive NAL ER followed by NAL ER co-administered with pirfenidone.
Cohort A1 - NAL ER + Pirfenidone	Pirfenidone	Participants will receive NAL ER followed by NAL ER co-administered with pirfenidone.
Cohort A2 - NAL ER + Nintedanib	NAL ER	Participants will receive NAL ER followed by NAL ER co-administered with nintedanib.
Cohort A2 - NAL ER + Nintedanib	Nintedanib	Participants will receive NAL ER followed by NAL ER co-administered with nintedanib.
Cohort B1 - Pirfenidone + NAL ER	NAL ER	Participants will receive pirfenidone followed by pirfenidone co-administered with NAL ER.
Cohort B1 - Pirfenidone + NAL ER	Pirfenidone	Participants will receive pirfenidone followed by pirfenidone co-administered with NAL ER.
Cohort B2 - Nintedanib + NAL ER	NAL ER	Participants will receive nintedanib followed by nintedanib co-administered with NAL ER.
Cohort B2 - Nintedanib + NAL ER	Nintedanib	Participants will receive nintedanib followed by nintedanib co-administered with NAL ER.

Primary Outcome Measures

Name	Time	Method
Maximum Plasma Concentration (Cmax) of NAL ER, Pirfenidone, and Nintedanib	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	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	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	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	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	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 Clearance (CL/F) of NAL ER, Pirfenidone, and Nintedanib	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 Volume of Distribution (Vz/F) of NAL ER, Pirfenidone, and Nintedanib	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 Outcome Measures

Name	Time	Method
Safety and Tolerability as Assessed by Number of Participants With Treatment Emergent Adverse Events (TEAEs)	Up to Day 21
Number of Participants With Clinically Significant Abnormalities in Vital Signs	Up to Day 21

Trial Locations

Locations (1)

Clinical Pharmacology of Miami; 🇺🇸 Miami, Florida, United States