MedTrace Logo

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

NCT04638803 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2021-11-10

No results posted yet for this study

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

Interventions

DRUG

PRX-P4-003, (-)-FCF

sequential study

Sponsors & Collaborators

  • Praxis Bioresearch, LLC

    lead INDUSTRY

Principal Investigators

  • Kore Liow, MD · Hawaii Pacific Neuroscience

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-02-25
Primary Completion
2021-10-30
Completion
2021-10-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04638803 on ClinicalTrials.gov