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

NCT07487740 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: NAL00-107
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Participants

Outcome Measures

Primary Outcomes (1)

• Relative Bioavailability of NAL ER

  Predose and at multiple timepoints postdose (from Day 1 to Day 8)

Secondary Outcomes (7)

• Maximum Plasma Concentration (Cmax) of NAL ER

  Predose and at multiple timepoints postdose (from Day 1 to Day 8)

• Time to Reach Maximum Observed Concentration (Tmax) of NAL ER

  Predose and at multiple timepoints postdose (from Day 1 to Day 8)

• Area Under the Concentration-Time Curve From Time Zero to Time of Last Measurable Concentration (AUC0-Tlast) of NAL ER

  Predose and at multiple timepoints postdose (from Day 1 to Day 8)

• Area Under the Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of NAL ER

  Predose and at multiple timepoints postdose (from Day 1 to Day 8)

• Apparent Terminal Rate Constant (λz) of NAL ER

  Predose and at multiple timepoints postdose (from Day 1 to Day 8)

Study Arms (2)

Cohort 1: NAL ER Dose A

EXPERIMENTAL

Participants will receive NAL ER Dose A on Day 1 in the fasted state, followed by dosing on Day 5 in the fed state in the first sequence, and vice versa in the second sequence, with a 3-day washout maintained between sequences.

Drug: NAL ER

Cohort 2: NAL ER Dose B

EXPERIMENTAL

Participants will receive NAL ER Dose B on Day 1 in the fasted state, followed by dosing on Day 5 in the fed state in the first sequence, and vice versa in the second sequence, with a 3-day washout maintained between sequences.

Drug: NAL ER

Interventions

NAL ER DRUG

Oral tablets

Also known as: Nalbuphine

Cohort 1: NAL ER Dose A; Cohort 2: NAL ER Dose B

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Trevi Therapeutics: lead

Study Sites (1)

Clinical Pharmacology of Miami, LLC.

Miami, Florida, 33172, United States

RECRUITING

MeSH Terms

Interventions

Nalbuphine

Intervention Hierarchy (Ancestors)

Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Chief Development Officer

  Trevi Therapeutics

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2026
• First Posted: March 23, 2026
• Study Start: February 27, 2026
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: March 23, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)