Healthy Participants
Conditions
Brief summary
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.
Interventions
Sponsors
Trevi Therapeutics
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Apparent Volume of Distribution (Vz/F) of NAL ER, Pirfenidone, and Nintedanib | 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 |
| Apparent Terminal Half-Life (t1/2) of NAL ER, Pirfenidone, and Nintedanib | 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 |
| Apparent Clearance (CL/F) of NAL ER, Pirfenidone, and Nintedanib | 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 |
| Maximum Plasma Concentration (Cmax) of NAL ER, Pirfenidone, and Nintedanib | 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 |
| Time to Reach Maximum Observed Concentration (Tmax) of NAL ER, Pirfenidone, and Nintedanib | 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 |
| Area Under the Concentration-Time Curve From Time Zero to Time of Last Measurable Concentration (AUC0-Tlast) of NAL ER, Pirfenidone, and Nintedanib | 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 |
| Area Under the Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of NAL ER, Pirfenidone, and Nintedanib | 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 |
| Apparent Terminal Rate Constant (λz) of NAL ER, Pirfenidone, and Nintedanib | 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
| Measure | Time frame |
|---|---|
| Number of Participants With Clinically Significant Abnormalities in Vital Signs | Up to Day 21 |
| Safety and Tolerability as Assessed by Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Up to Day 21 |
Countries
United States
Outcome results
None listed