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NCT Number: NCT07487740

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

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.

Recruiting

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Clinical Pharmacology of Miami, LLC.

Miami, Florida, 33172, United States

Location status: Recruiting

Location contact

Hadaza Catala

CONTACT

[email protected]

305-817-2900 ext. +1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

NAL ER

Drug

Oral tablets

Other names: Nalbuphine

Primary outcomes

  1. Relative Bioavailability of NAL ER

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

Secondary outcomes

  1. Maximum Plasma Concentration (Cmax) of NAL ER

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

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

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

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

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

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

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

  5. Apparent Terminal Rate Constant (λz) of NAL ER

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

  6. Apparent Terminal Half-Life (t1/2) of NAL ER

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

  7. Safety and Tolerability as Assessed by Number of Participants With Treatment Emergent Adverse Events (TEAEs)

    Time frame: Up to Day 18

Sponsors and collaborators

Lead sponsor

Trevi Therapeutics

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 23, 2026
Registry last updated
Mar 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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