Actively Recruiting
A Randomized, Open-Label, Two-Treatment, Two-Period, Two-Sequence, Single-Dose Crossover Study of Food Effect on Nalbuphine Extended-Release Tablets in Healthy Adults
Led by Trevi Therapeutics · Updated on 2026-03-23
60
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying how a high-fat, high-calorie meal affects the way the body absorbs Nalbuphine Extended-Release Tablets NAL ER after a single oral dose in healthy adults. This phase 1 study aims to understand the relative bioavailability of NAL ER under different dietary conditions. The research is sponsored by Trevi Therapeutics and involves healthy volunteers aged 18 to 60 years with normal body weight and medical health. Participants receive two different doses of NAL ER in a crossover design. They take one dose while fasting and another dose after eating a high-fat, high-calorie meal, with a 3-day break between doses. The study includes two sequences where the order of fasting and fed dosing is reversed, allowing comparison of how food impacts drug absorption. During the study, participants are monitored from Day 1 to Day 8 with blood samples taken at multiple times to measure drug levels, including peak concentration and how long the drug stays in the body. Safety is assessed by tracking any treatment-related side effects up to Day 18. This helps researchers understand the drugs behavior and tolerability under different conditions, with the total participation lasting several weeks.
CONDITIONS
Brief Title
A Food Effect Study to Evaluate the Relative Bioavailability of Nalbuphine Extended-Release Tablets (NAL ER) in Healthy Participants
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Body mass index (BMI) between 18.0 and 30.0 kg/m2 at Screening
- Medically healthy with no significant medical history or abnormal physical exam, lab tests, vital signs, or ECG
- Age between 18 and 60 years
- Healthy volunteers able to comply with study requirements
You will not qualify if you...
- Positive test for COVID-19 at Screening or Day -1
- History or presence of alcohol or drug abuse within 2 years prior to first dose
- Positive urine drug or alcohol test at Screening or Day -1
- Smoking or nicotine use within last 3 months, confirmed negative cotinine test
- History of allergy or unusual reaction to study drug or related compounds
- Abnormal hemoglobin, neutrophil count, or platelet levels at Screening
- History of prolonged QT syndrome or corrected QT interval (QTc)
- Positive test for HIV, hepatitis B surface antigen, or hepatitis C virus at Screening
- Participation in another clinical study within 5 half-lives or 30 days before Baseline visit
- Other protocol-specific inclusion/exclusion criteria may apply
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