COMPLETED

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

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Healthy Participants

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

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

Quick Facts

Study Start:2025-06-30
Study Completion:2025-09-26
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT07015398

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.

Ages Eligible for Study:18 Years to 60 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Body mass index (BMI) ≥ 18.0 and ≤ 30.0 kilogram per meter square (kg/m\^2) at Screening.
  2. * 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.
  1. * Positive results for coronavirus infection (COVID-19).
  2. * History or presence of alcohol or drug abuse.
  3. * Positive urine drug or alcohol results.
  4. * Smoker who has used nicotine containing products within the last 3 months.
  5. * History or presence of hypersensitivity or idiosyncratic reaction to the study drugs or related compounds.
  6. * Hemoglobin, absolute neutrophil count, or platelet levels outside of the reference range at Screening.
  7. * History of prolonged QT syndrome or a QTc interval.
  8. * Abnormal liver function at Screening or historical or concurrent liver disease.
  9. * Positive results for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV).
  10. * Abnormal Estimated glomerular filtration rate (eGFR).
  11. * History of difficulty donating blood or donation of blood or plasma within 56 days of Screening.
  12. * Participation in another clinical study within 30 days of the baseline visit.

Contacts and Locations

Principal Investigator

Chief Development Officer
STUDY_DIRECTOR
Trevi Therapeutics

Study Locations (Sites)

Clinical Pharmacology of Miami
Miami, Florida, 33172
United States

Collaborators and Investigators

Sponsor: Trevi Therapeutics

  • Chief Development Officer, STUDY_DIRECTOR, Trevi Therapeutics

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-06-30
Study Completion Date2025-09-26

Study Record Updates

Study Start Date2025-06-30
Study Completion Date2025-09-26

Terms related to this study

Additional Relevant MeSH Terms

  • Healthy Participants