Healthy Participants
Conditions
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.
Interventions
DRUGNAL ER
Oral tablets
Sponsors
Trevi Therapeutics
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Relative Bioavailability of NAL ER | Predose and at multiple timepoints postdose (from Day 1 to Day 8) |
Secondary
| Measure | Time frame |
|---|---|
| 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) |
| Apparent Terminal Half-Life (t1/2) of NAL ER | Predose and at multiple timepoints postdose (from Day 1 to Day 8) |
| Safety and Tolerability as Assessed by Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Up to Day 18 |
Countries
United States
Contacts
STUDY_DIRECTORChief Development Officer
Trevi Therapeutics
Outcome results
None listed