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Food Effect Study for Nalbuphine Extended-Release Tablets

This study is looking for healthy volunteers aged 18 to 60 to understand how a high-fat, high-calorie meal affects the body's absorption of Nalbuphine Extended-Release Tablets (NAL ER). NAL ER is given as oral tablets. The main goal is to measure how much NAL ER gets into your bloodstream and how long it stays there when taken with food. To join, you should be generally healthy with a Body Mass Index (BMI) between 18.0 and 30.0. The study plans to enroll 60 participants.

Study design
This is an interventional study involving 60 healthy participants. It aims to evaluate the relative bioavailability of NAL ER.
What's involved
You would take single oral doses of NAL ER. Blood samples will be collected before the dose and at various times up to 8 days after the dose.
Compensation
Not stated in the trial record.
Follow-up
Your blood levels of NAL ER will be measured from before the dose up to 8 days after the dose.

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NCT07487740

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

Completed
PHASE1Ages 18–60InterventionalTreatment
Trevi Therapeutics
~60 participants
Updated 2026-08-21 on ClinicalTrials.gov
What's tested:NAL ER

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Relative Bioavailability of NAL ER
Measured over Predose and at multiple timepoints postdose (from Day 1 to Day 8)

Conditions

Healthy Participants

Explore related trials

Healthy Participants

Where it's being run

1 sites across 1 states
Florida1

Study leadership

  • Chief Development Officer · STUDY_DIRECTOR · Trevi Therapeutics

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Relative Bioavailability of NAL ERPredose and at multiple timepoints postdose (from Day 1 to Day 8)