RecruitingPhase 1NCT07487740

A Food Effect Study to Evaluate the Relative Bioavailability of Nalbuphine Extended-Release Tablets (NAL ER) in Healthy Participants

A Randomized, Phase 1, Open-Label, Two-Treatment, Two- Period, Two-Sequence, Single-Dose Crossover Study to Evaluate the Effect of Food on the Relative Bioavailability of Nalbuphine Extended-Release Tablets (NAL ER) in Healthy Subjects

Sponsor

Trevi Therapeutics

Enrollment

60 participants

Start Date

Feb 27, 2026

Study Type

INTERVENTIONAL

Conditions

Healthy Participants

Summary

The primary purpose of this study is to evaluate the effect of a high-fat, high-calorie meal on the relative bioavailability of NAL ER following single oral doses.

Eligibility

Min Age: 18 YearsMax Age: 60 Years

Inclusion Criteria2

Body mass index (BMI) ≥ 18.0 and ≤ 30.0 kilogram per meter square (kg/m2) 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 Criteria9

Positive results for coronavirus infection (COVID-19) at Screening or check-in (Day -1).
History or presence of alcohol or drug abuse within the past 2 years prior to the first dosing.
Positive urine drug or alcohol results at Screening or check in (Day -1).
Smoker who has smoked or used nicotine containing products within the last 3 months prior to the first dose and throughout the study, confirmed by a negative cotinine test at Screening and check-in (Day -1).
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 corrected QT (QTc) interval.
Positive results at Screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV).
Participation in another clinical study within 5 half-lives or 30 days, whichever is longer, of the Baseline visit.