A Phase 0, Open-Label, Crossover Microdose Pharmacokinetic Study of PRX-P4-003 in Healthy Volunteers

This study will evaluate the pharmacokinetics of a single oral microdose of PRX-P4-003 in healthy male volunteers in a fasted state (Study A) and a fed state (Study B).

Inclusion criteria

• Healthy male volunteers aged 18 to 45 years
• Body Mass Index (BMI) between 18 and 32 kg/m² (inclusive)
• Normal resting heart rate (50 to 100 bpm) and blood pressure (systolic 90-130 mmHg, diastolic 60-85 mmHg) at Screening and Day 0
• Willingness to provide written informed consent and HIPAA authorization, and agreement to use a highly effective method of birth control during the study and for 1 month after study drug administration
• Nonsmoker (no smoking within 6 months of Screening Visit 1); no medicinal or recreational marijuana use within 3 months prior to screening or during the study
• Willingness to fast for at least 8 hours overnight and 4 hours post-dose (for Study A)
• Ability to communicate well with the investigator and comply with clinic procedures

Exclusion criteria

• History or presence of any clinically significant respiratory, gastrointestinal, renal, hepatic, hematological, neurological (including seizure history), cardiovascular, psychiatric (including known addictive disorders), musculoskeletal, genitourinary, immunological, or dermatological disorders
• History of suicide attempts or current suicidal ideation
• Clinically significant abnormal physical, neurological, or laboratory findings, or abnormal ECG (including average QTc interval ≥ 450 msec or a history of congenitally prolonged QT interval)
• Need for prescription medications within 14 days (or 5 half-lives) prior to dosing
• Acetaminophen use > 1000 mg (single dose) within 3 days prior to Day 1
• Use of any investigational drug, medical device, or herbal medicine within 3 months prior to or during the study
• Known hypersensitivity or intolerance to drugs with the same mechanism of action as PRX-P4-003 or (-)-fencamfamine
• History of alcohol abuse (>4 drinks/day) or drug addiction within the past 2 years; positive urine drug or alcohol screen at Screening or Day -1
• Unwillingness to refrain from alcohol or drugs 24 hours prior to Day -1 and during the inpatient stay
• Seropositive for Hepatitis B, Hepatitis C, or known HIV infection
• Donation or loss of > 500 mL of blood in the 8 weeks prior to dosing, or planned donation during trial participation
• Inability or unwillingness to comply with protocol requirements/appointments, or inability to understand English (unless a certified translation of the informed consent is available)