A Phase I Study of NS-079 in Healthy Participants

Exclusion criteria

• . Known hypersensitivity or allergy to the investigational product, its excipients, or any of its components, or a history of clinically significant allergic reactions that, in the opinion of the investigator/delegate, may place the participant at increased risk.
• . Known hypersensitivity to or severe intolerance of paroxetine or any SSRI (including serotonin syndrome or discontinuation syndrome) (for Part 3 \[DDI\] only).
• . Unable to refrain from all known CYP2D6 substrate medications (including over-the-counter (OTC) medications such as dextromethorphan-containing cough and cold preparations) during paroxetine dosing (for Part 3 \[DDI\] only). Final clinical judgment on individual concomitant medications remains with the investigator/delegate.
• . Individuals with a history of intolerance to venipuncture or venous catheterization (e.g., recurrent syncope during blood draws or significant needle phobia) that, in the opinion of the investigator/delegate, may interfere with the study procedures.
• . Positive serologic test results for hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (Anti-HCV) or human immunodeficiency virus antibody (Anti-HIV) at Screening.
• . Average daily smoking of more than 5 cigarettes per day in the 3 months prior to Screening, or inability or unwillingness to abstain from the use of tobacco or nicotine-containing products (including cigarettes, e-cigarettes, vaping products, and nicotine replacement products) from 48 hours prior to the first dose through completion of the final safety follow-up visit.
• . Excessive alcohol consumption, defined as average weekly alcohol intake exceeding 14 units during the 4 weeks prior to Screening (1 unit ≈10 g of pure alcohol; 1 alcohol unit is equal to 375ml 3.5% beer, 100 mL of wine, or 30 mL of 40% spirit), unwillingness or inability to abstain from alcohol and alcohol-containing products from 48 hours prior to the first dose through the completion of the final safety follow-up visit, or a positive alcohol breath test at Screening or upon admission to the clinical unit. (A repeat test may be performed once per timepoint at the investigator/delegate's discretion).
• . Excessive consumption of caffeinated beverages (e.g., coffee, tea, energy drinks), defined as an average of \>8 cups/day (1 cup ≈ 250 mL) within 3 months prior to screening, or unwillingness or inability to refrain from caffeinated beverages from 48 hours prior to the first dose through the end of the inpatient confinement phase.

Main pharmacokinetic parameters

Timeframe: for SAD, day 1-4; for MAD, day 1-14, for DDI, day1-30