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COMPLETED
NCT04638803
EARLY_PHASE1

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

Sponsor: Praxis Bioresearch, LLC

View on ClinicalTrials.gov

Summary

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

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

Key Details

Gender

MALE

Age Range

18 Years - 45 Years

Study Type

INTERVENTIONAL

Enrollment

6

Start Date

2021-02-25

Completion Date

2021-10-31

Last Updated

2026-09-17

Healthy Volunteers

Yes

Conditions

Interventions

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.

DRUG

(-)-FCF

40 µg single oral dose dissolved in 8 oz (240 mL) of water as a liquid solution.

Locations (1)

Hawaii Pacific Neuroscience

Honolulu, Hawaii, United States