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OpenTrials
Completed

NCT Number: NCT07015398

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

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.

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Key information

Conditions

Healthy Participants

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Clinical Pharmacology of Miami

Miami, Florida, 33172, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.]

Treatment and study plan

NAL ER

Drug

Oral tablets

Other names: Nalbuphine Extended Release

pirfenidone

Drug

Oral tablets

Other names: ESBRIET®

Nintedanib

Drug

Oral capsules

Other names: OFEV®

Primary outcomes

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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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)

    Time frame: Up to Day 21

  2. Number of Participants With Clinically Significant Abnormalities in Vital Signs

    Time frame: Up to Day 21

Sponsors and collaborators

Lead sponsor

Trevi Therapeutics

Industry

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jun 11, 2025
Registry last updated
Oct 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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