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

Phase 1

Not yet recruiting

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

• Registration Number: NCT07015398
• Lead Sponsor: Trevi Therapeutics

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-06
• Study Start: 2025-06
• Study First Submitted: 2025-06-03
• Study First Submitted QC: 2025-06-03
• Last Update Submitted: 2025-06-03
• Study First Posted: 2025-06-11
• Last Update Posted: 2025-06-11
• Primary Completion: 2025-08
• Study Completion: 2025-08

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 115

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.]

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Maximum Plasma Concentration (Cmax) of NAL ER, Pirfenidone, and Nintedanib	Cohorts A1 and A2: Pre-dose and at multiple points post-dose on Days 6 and 12; Cohorts B1 and B2: Pre-dose and at multiple points post-dose on Days 5 and 10
Time to Reach Maximum Observed Concentration (Tmax) of NAL ER, Pirfenidone, and Nintedanib	Cohorts A1 and A2: Pre-dose and at multiple points post-dose on Days 6 and 12; Cohorts B1 and B2: Pre-dose and at multiple points post-dose on Days 5 and 10
Area Under the Concentration-Time Curve From Time Zero to End of a Dosing Interval (AUC0-tau) of NAL ER, Pirfenidone, and Nintedanib	Cohorts A1 and A2: Pre-dose and at multiple points post-dose on Days 6 and 12; Cohorts B1 and B2: Pre-dose and at multiple points post-dose on Days 5 and 10

Secondary Outcome Measures

Name	Time	Method
Safety and Tolerability as Assessed by Number of Participants With Treatment Emergent Adverse Events (TEAEs)	Cohorts A1 and A2: Up to Day 23; Cohorts B1 and B2: Up to Day 21
Number of Participants With Clinically Significant Abnormalities in Vital Signs	Cohorts A1 and A2: Up to Day 23; Cohorts B1 and B2: Up to Day 21