Microdose Pharmacokinetic Study of PRX-P4-003 In Healthy Volunteers

NCT04638803 | Completed Early Phase 1 FDA Drug

• 2 other identifiers: PBR001R44116764
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of the present study is to confirm in humans the in-vivo bioconversion of a Prodrug (PRX-P4-003) to (-)-fencamfamine (FCF) the active moiety when orally administered as a single microdose. A second component of the study will evaluate effect of food on pharmacokinetics of PRX-P4-003.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• Outcome

  Plasma (-)-FCF exposure (AUC 0-t) after Oral dosing of PRX-P4-003 and (-)-FCF

  24 hours

Study Arms (2)

Crossover (fasted)

EXPERIMENTAL

On Day 1 subjects are dosed with 100 µg of PRX-P4-003 and PK samples are drawn according to protocol, on Day 15 subjects are dosed with 40 µg of (-)-FCF. Both treatment will be administered under the fasted conditions.

Drug: PRX-P4-003, (-)-FCF

Single Group (fed)

EXPERIMENTAL

On Day 1 subjects are dosed with 100 µg of PRX-P4-003 and PK samples are drawn according to protocol. The treatment will be administered under the fed condition.

Drug: PRX-P4-003, (-)-FCF

Interventions

PRX-P4-003, (-)-FCF DRUG

sequential study

Also known as: Prodrug, Stimulant

Crossover (fasted); Single Group (fed)

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Male age 18 to 45 years, participants must be willing to fast for 10 hours
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male aged 18 to 45 years. Willing to fast for at least 8 hours overnight and 4 hours after study drug dose (Study A).
• BMI within 18 - 32 kg/m2, inclusive.
• Willing/able to provide signed Informed Consent Form \& HIPAA authorization for this study.
• Agreement to use a highly effective method of birth control with partners of childbearing potential during the study and for 1 month after study dosing such as, abstinence, barrier methods.
• Normal heart rate (50 to 100 bpm) and blood pressure (diastolic 60-85 mm Hg and systolic 90 to 130 mm Hg, inclusive) at Screening and Day 0.
• Nonsmoker or has not smoked within the past 6 months of Screening Visit 1 and throughout study participation. Use of recreational and/or medicinal marijuana are NOT permitted within 3 months prior to Screening and during the study. Marijuana use should not be initiated after Screening.
• Able to communicate well with the Investigator and to comply with the study procedures, requirements, restrictions, and directions of the clinic staff.

You may not qualify if:

• Subjects who meet the following criteria are excluded from study participation
• History or presence of clinically significant respiratory, GI, renal, hepatic, hematological, neurological (including history of seizure), cardiovascular, psychiatric (including known addictive disorders), musculoskeletal, genitourinary, immunological, or dermatological disorders. The existence of any surgical or medical condition that, in the judgment of the clinical Investigator, might jeopardize the subject's safety, tolerability or interfere with the absorption, distribution, metabolism or excretion of the study drug.
• Any history of suicide attempts or current suicidal ideation.
• Abnormal clinically significant laboratory, physical, or neurological findings during screening.
• Abnormal and clinically significant ECG (as determined by the Investigator or his/her designee) at Screening or Day -0. Abnormalities include, but are not limited to, QTc interval (average of three ECGs) greater than or equal to 450 msec based on 12 lead ECG at Screening or Day -1. Subjects with a history of congenitally prolonged QT interval.
• In the 14 days (or 5 half-lives, whichever is longer) prior to dosing, the need for prescription medications.
• Use of acetaminophen greater than a single dose of 1000 mg up to 3 days prior to Day 1.
• Use of any investigational drug or medical device within 3 months prior to study admission.
• Known hypersensitivity to, or intolerance of, drugs with the same mechanism of action as PRX-P4-003 or (-)-fencamfamine.
• Donation or loss of greater than 500 mL of blood in the 8 weeks before dosing. or planned donation of blood at any time during trial participation.
• History of alcohol abuse (defined as regular or daily consumption of more than 4 alcoholic drinks per day) or drug addiction within the past 2 years, as determined by the Investigator. A positive urine drug, or positive alcohol urine (or breath) test at Screening or Day-1.
• Unwillingness to refrain from alcohol, or illicit or recreational drugs, within 24 hours prior to Day -1and during inpatient period.
• Seropositive for Hepatitis B, Hepatitis C, (tested during screening) or known HIV infection.
• The subject is unwilling or unable to comply with the protocol or scheduled appointments.
• The subject is unable to understand verbal or written English or any other language for which a certified translation of the approved informed consent is available.

Sponsors & Collaborators

• Praxis Bioresearch, LLC: lead

Study Sites (1)

Hawaii Pacific Neuroscience

Honolulu, Hawaii, 96817, United States

Location

MeSH Terms

Interventions

Prodrugs; Central Nervous System Stimulants

Intervention Hierarchy (Ancestors)

Pharmaceutical Preparations; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Central Nervous System Agents; Therapeutic Uses

Study Officials

• Kore Liow, MD

  Hawaii Pacific Neuroscience

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: In the first arm a fixed order crossover of a PRX-P4-003 followed by administration of the (-)-FCF after a washout period. In the second arm a separate cohort will be administered PRX-P4-003 under fed conditions.

Study Record Dates

• First Submitted: November 4, 2020
• First Posted: November 20, 2020
• Study Start: February 25, 2021
• Primary Completion: October 30, 2021
• Study Completion: October 31, 2021
• Last Updated: November 10, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)