Overview
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
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.
