Microdose Pharmacokinetic Study of PRX-P4-003 In Healthy Volunteers
Public ClinicalTrials.gov record NCT04638803. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 0, Open-Label, Crossover Microdose Pharmacokinetic Study of PRX-P4-003 In Healthy Volunteers
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04638803
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Early Phase 1
- Enrollment
- 6 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 45 Years
- Sex
- Male
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Feb 24, 2021
- Primary completion
- Oct 29, 2021
- Completion
- Oct 30, 2021
- Last update posted
- Nov 9, 2021
2021
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Hawaii Pacific Neuroscience | Honolulu | Hawaii | 96817 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04638803, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Nov 9, 2021 · Synced Sep 3, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04638803 live on ClinicalTrials.gov.