RECRUITING

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

Description

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.

Conditions

Healthy Participants
Talk to us

Related Conditions:

Healthy Participants

Study Overview

On this page

Study Details

Study overview

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.

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

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

Condition
Healthy Participants
Intervention / Treatment

-

Contacts and Locations

Miami

Clinical Pharmacology of Miami, Miami, Florida, United States, 33172

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

18 Years to 60 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Trevi Therapeutics,

Chief Development Officer, STUDY_DIRECTOR, Trevi Therapeutics

Study Record Dates

2025-09