NCT07487740 A Food Effect Study to Evaluate the Relative Bioavailability of Nalbuphine Extended-Release Tablets (NAL ER) in Healthy Participants
| NCT ID | NCT07487740 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Trevi Therapeutics |
| Condition | Healthy Participants |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2026-02-27 |
| Primary Completion | 2026-04 |
Trial Parameters
Eligibility Fast-Check
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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.
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