Drug-Drug Interaction Study of HBI-3000 and Paroxetine in Healthy Adult Male and Female Subjects

Open-Label, Two-Period Phase 1 Study in Healthy Subjects to Evaluate the Potential Effect of Multiple Doses of Paroxetine on the Pharmacokinetics and Safety of HBI-3000

Drug-Drug Interaction Study of HBI-3000 and Paroxetine in Healthy Adult Male and Female Subjects

This is a Phase 1 study in healthy volunteers to evaluate the potential effect of multiple doses of paroxetine on the pharmacokinetics and safety of HBI-3000. Each subject serves as his/her own control: Period 1 vs. Period 2.

Inclusion Criteria:

Healthy adult males and females

• 18 - 50 years of age
• BMI 18 - 32 kg/m2
• Subject has no clinically significant abnormality on electrocardiogram (ECG)
• Subject has been a nonsmoker and/or has not used nicotine or nicotine-containing products for at least 4 months
• Subject is willing to comply with the study restrictions, including contraception requirements

Exclusion Criteria:

• Evidence of a clinically significant disease or abnormalities, including an active, current infection or clinically significant infection within 8 weeks prior to the first dose
• Severe allergic reaction, angioedema, or anaphylaxis to drugs, or food or latex allergies
• Subject has an estimated creatinine clearance of ≤ 70 mL
• Subject has evidence of a clinically significant deviation from normal in the physical examination, vital signs, or clinical laboratory determinations
• Subject has significant ECG abnormality, history or presence of cardiac arrhythmia or conduction abnormalities, or bradycardia (< 45 bpm)
• Subject has a history of vasovagal syncope, or symptomatic orthostatic hypotension
• Subject has as a history of or current alcohol abuse and/or other drug addiction
• Subject has received an investigational drug (including investigational vaccines) within 5 half-lives of such drug prior to Study Day 1
• Subject has received CYP2D inhibitors (e.g., fluoxetine, sertraline, duloxetine, bupropion, chloroquine, cimetidine, diphenhydramine) less than 3 weeks prior to administration of the initial dose of study drug
• Subject has suicidal thinking and behavior (suicidality) or other significant psychiatric disorders based on self-disclosure during interview (Screening visit)
• Subject has a history of acute narrow-angle glaucoma
• Subject has as any condition that would make him or her, in the opinion of the Investigator or Sponsor, unsuitable for the study