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Clinical trialNCT04638803CompletedEarly phase 1Interventional

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

SponsorPraxis Bioresearch, LLCEnrollment6Healthy Volunteers
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.
clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

1 registered facility, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States
  • Hawaii Pacific Neuroscience

    Honolulu, Hawaii, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

PRX-P4-003,-FCF
Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
25 Feb 2021
Primary completion
30 Oct 2021
Completion
31 Oct 2021
Last update posted
10 Nov 2021
Registered enrollment
6
Registry id
NCT04638803
clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 30 Jul 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.