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

NCT07487740

CompletedPhase 1

Sponsor: Trevi Therapeutics

Conditions: Healthy Participants

Interventions: NAL ER

Countries: United States

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 overview

Sex: ALL

Age: 18 Years to 60 Years

Healthy volunteers: Yes

Study type: INTERVENTIONAL

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.

Locations (1)

Miami, Florida, United States