Healthy
Conditions
Brief summary
This is a Phase 0, open-label, crossover microdose pharmacokinetic study of PRX-P4-003 in healthy volunteers.
Detailed description
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).
Interventions
DRUGPRX-P4-003
100 µg single oral microdose formulated as an oil-based lipid solution, hand-filled on-site into hard-shell Capsugel capsules and swallowed with 8 oz (240 mL) of water.
DRUG(-)-FCF
40 µg single oral dose dissolved in 8 oz (240 mL) of water as a liquid solution.
Sponsors
Praxis Bioresearch, LLC
National Institute of Mental Health (NIMH)
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Intervention model description
Fasted crossover comparison of PRX-P4-003 and (-)-fencamfamine (Study A) plus a fed PK cohort (Study B).
Eligibility
Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Systemic Exposure (AUC0-t) of Active (-)-fencamfamine [(-)-FCF] | Up to 24 hours post-dose (pre-dose [15-30 minutes prior], and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 9, 12, and 24 hours post-dose) | Determination of the average exposure of active (-)-fencamfamine \[(-)-FCF\], as measured by the Area Under the plasma concentration-time Curve to the last measurable concentration (AUC0-t), following single oral microdose administration of PRX-P4-003 (100 µg) and the reference drug (-)-FCF HCl (40 µg). |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORKore Liow, MD
Hawaii Pacific Neuroscience
Outcome results
None listed