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

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

This is a Phase 0, open-label, crossover microdose pharmacokinetic study of PRX-P4-003 in healthy volunteers.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: PRX-P4-003; Drug: (-)-FCF

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).

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • Hawaii
    • Honolulu, Hawaii, United States, 96817
      • Hawaii Pacific Neuroscience

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PRX-P4-003 - Fasted; Single 100 µg oral microdose of PRX-P4-003 administered under fasted conditions.	Drug: PRX-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.
Experimental: (-)-FCF - Fasted; Single 40 µg oral dose of (-)-fencamfamine hydrochloride [(-)-FCF HCl] administered under fasted conditions.	Drug: (-)-FCF; 40 µg single oral dose dissolved in 8 oz (240 mL) of water as a liquid solution.; Other Names: (-)-fencamfamine hydrochloride, (-)-FCF HCl
Experimental: PRX-P4-003 - Fed; Single 100 µg oral microdose of PRX-P4-003 administered under fed conditions.	Drug: PRX-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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Systemic Exposure (AUC0-t) of Active (-)-fencamfamine [(-)-FCF]	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).	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)

Collaborators and Investigators

• Sponsor: Praxis Bioresearch, LLC
• Collaborators: National Institute of Mental Health (NIMH)
• Investigators: Principal Investigator: Kore Liow, MD, Hawaii Pacific Neuroscience

Study record dates

Study Major Dates

• Study Start (Actual): February 25, 2021
• Primary Completion (Actual): October 30, 2021
• Study Completion (Actual): October 31, 2021

Study Registration Dates

• First Submitted: November 4, 2020
• First Submitted That Met QC Criteria: November 16, 2020
• First Posted (Actual): November 20, 2020

Study Record Updates

• Last Update Posted (Actual): September 17, 2026
• Last Update Submitted That Met QC Criteria: September 14, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; fencamfamine
• Other Study ID Numbers: PBR001; R44MH116764 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No