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

Trevi Therapeutics132 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

132

Conditions

Healthy Participants

Interventions

NAL ERDRUG

Oral tablets

PirfenidoneDRUG

Oral tablets

NintedanibDRUG

Oral capsules

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Clinical Pharmacology of Miami

Miami, Florida, United States