Food effect on nalbuphine extended-release tablet absorption in healthy adults

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

This will see if a high-fat, high-calorie meal changes how nalbuphine extended-release tablets are absorbed in healthy adults.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years to 60 Years
• Sex: All
• Sponsor: Trevi Therapeutics (Industry-sponsored)
• Locations: 1 site (Miami, Florida)
• Trial ID: NCT07487740 on ClinicalTrials.gov

What this trial studies

This Phase 1 pharmacokinetic study tests whether a high-fat, high-calorie meal alters the relative bioavailability of a single oral dose of nalbuphine extended-release (NAL ER) tablets. Healthy volunteers will receive NAL ER and have timed blood samples taken to measure drug concentrations and pharmacokinetic parameters under fed and fasting conditions. Safety monitoring will include vital signs, laboratory tests, ECGs, and adverse event reporting. The study is conducted at a single clinical pharmacology site in Miami, Florida.

Who should consider this trial

Good fit: Healthy adults with a BMI of 18.0–30.0 kg/m2 who are non-smokers, have no significant medical history, and pass screening labs and drug tests are ideal candidates.

Not a fit: People with significant medical conditions, recent substance or alcohol abuse, positive drug or COVID-19 tests, smokers, pregnant people, or those outside the BMI limits are unlikely to benefit from this healthy-volunteer PK study.

Why it matters

Potential benefit: If successful, the results could inform labeling and dosing instructions by showing whether nalbuphine ER should be taken with or without food.

How similar studies have performed: Food-effect pharmacokinetic studies are a standard approach and have characterized food impacts on other extended-release opioid formulations, though nalbuphine ER–specific data may be limited.

Eligibility criteria

Inclusion Criteria:

* 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 Criteria:

* 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.

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

Where this trial is running

Miami, Florida

• Clinical Pharmacology of Miami, LLC. — Miami, Florida, United States (Recruiting)

Conditions Healthy Participants