Clinical trial NCT07015398: A Study of the Pharmacokinetic Interaction Between Pirfenidone, Nintedanib, and Nalbuphine Extended Release (NAL ER) in Healthy Participants
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Healthy Participants
Lead sponsor: Trevi Therapeutics
Sponsor class: INDUSTRY
First posted: 2025-06-11
Enrollment: 115
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

\[Note: Other inclusion/exclusion criteria mentioned in the protocol may apply.\]

Primary outcomes:
measure: Maximum Plasma Concentration (Cmax) of NAL ER, Pirfenidone, and Nintedanib
timeFrame: 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
measure: Time to Reach Maximum Observed Concentration (Tmax) of NAL ER, Pirfenidone, and Nintedanib
timeFrame: 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
measure: Area Under the Concentration-Time Curve From Time Zero to End of a Dosing Interval (AUC0-tau) of NAL ER, Pirfenidone, and Nintedanib
timeFrame: 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 outcomes:
measure: Safety and Tolerability as Assessed by Number of Participants With Treatment Emergent Adverse Events (TEAEs)
timeFrame: Cohorts A1 and A2: Up to Day 23; Cohorts B1 and B2: Up to Day 21
measure: Number of Participants With Clinically Significant Abnormalities in Vital Signs
timeFrame: Cohorts A1 and A2: Up to Day 23; Cohorts B1 and B2: Up to Day 21
Other outcomes:
Locations:
Study officials:
affiliation: Trevi Therapeutics
name: Chief Development Officer
role: STUDY_DIRECTOR
References: