HealthyEarly Phase 1NCT04638803
A Phase 0, Open-Label, Crossover Microdose Pharmacokinetic Study of PRX-P4-003 in Healthy Volunteers
A Early Phase 1 study testing PRX-P4-003 and (-)-FCF in people with Healthy, run by Praxis Bioresearch, LLC at 1 site in United States.
Trial summary
This is a Phase 0, open-label, crossover microdose pharmacokinetic study of PRX-P4-003 in healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- PRX-P4-003 and (-)-FCF
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Feb 2021to 31 Oct 2021
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male volunteers aged 18 to 45 years
- Body Mass Index (BMI) between 18 and 32 kg/m² (inclusive)
- Normal resting heart rate (50 to 100 bpm) and blood pressure (systolic 90-130 mmHg, diastolic 60-85 mmHg) at Screening and Day 0
- Willingness to provide written informed consent and HIPAA authorization, and agreement to use a highly effective method of birth control during the study and for 1 month after study drug administration
- Nonsmoker (no smoking within 6 months of Screening Visit 1); no medicinal or recreational marijuana use within 3 months prior to screening or during the study
- Willingness to fast for at least 8 hours overnight and 4 hours post-dose (for Study A)
- Ability to communicate well with the investigator and comply with clinic procedures
Who cannot join
- History or presence of any clinically significant respiratory, gastrointestinal, renal, hepatic, hematological, neurological (including seizure history), cardiovascular, psychiatric (including known addictive disorders), musculoskeletal, genitourinary, immunological, or dermatological disorders
- History of suicide attempts or current suicidal ideation
- Clinically significant abnormal physical, neurological, or laboratory findings, or abnormal ECG (including average QTc interval ≥ 450 msec or a history of congenitally prolonged QT interval)
- Need for prescription medications within 14 days (or 5 half-lives) prior to dosing
- Acetaminophen use > 1000 mg (single dose) within 3 days prior to Day 1
- Use of any investigational drug, medical device, or herbal medicine within 3 months prior to or during the study
Show all 12Show fewer
- Known hypersensitivity or intolerance to drugs with the same mechanism of action as PRX-P4-003 or (-)-fencamfamine
- History of alcohol abuse (>4 drinks/day) or drug addiction within the past 2 years; positive urine drug or alcohol screen at Screening or Day -1
- Unwillingness to refrain from alcohol or drugs 24 hours prior to Day -1 and during the inpatient stay
- Seropositive for Hepatitis B, Hepatitis C, or known HIV infection
- Donation or loss of > 500 mL of blood in the 8 weeks prior to dosing, or planned donation during trial participation
- Inability or unwillingness to comply with protocol requirements/appointments, or inability to understand English (unless a certified translation of the informed consent is available)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 0, Open-Label, Crossover Microdose Pharmacokinetic Study of Prodrug PRX-P4-003 in Healthy Volunteers
This is a Phase 0, open-label, crossover microdose pharmacokinetic study of PRX-P4-003 in healthy volunteers.
Read the detailed description
This study will evaluate the pharmacokinetics of a single oral microdose of PRX-P4-003 in healthy male volunteers in a fasted state (Study A) and a fed state (Study B).
- Conditions
- Healthy
- Being tested
- PRX-P4-003, (-)-FCF
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRX-P4-003Drug
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.
(-)-FCFDrug
Also called (-)-fencamfamine hydrochloride, (-)-FCF HCl
40 µg single oral dose dissolved in 8 oz (240 mL) of water as a liquid solution.
| Study group | Role | What they receive |
|---|---|---|
| PRX-P4-003 - Fasted | Experimental | Single 100 µg oral microdose of PRX-P4-003 administered under fasted conditions. Receives: Drug: PRX-P4-003 |
| (-)-FCF - Fasted | Experimental | Single 40 µg oral dose of (-)-fencamfamine hydrochloride [(-)-FCF HCl] administered under fasted conditions. Receives: Drug: (-)-FCF |
| PRX-P4-003 - Fed | Experimental | Single 100 µg oral microdose of PRX-P4-003 administered under fed conditions. Receives: Drug: PRX-P4-003 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systemic Exposure (AUC0-t) of Active (-)-fencamfamine [(-)-FCF]
Determination of the average exposure of active (-)-fencamfamine [(-)-FCF], as measured by the Area Under the plasma concentration-time Curve to the last measurable concentration (AUC0-t), following single oral microdose administration of PRX-P4-003 (100 µg) and the reference drug (-)-FCF HCl (40 µg).
Measured: Up to 24 hours post-dose (pre-dose [15-30 minutes prior], and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 9, 12, and 24 hours post-dose)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2020
- Study start25 Feb 2021
- Primary completion30 Oct 2021
- Study completion31 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Model description
- Fasted crossover comparison of PRX-P4-003 and (-)-fencamfamine (Study A) plus a fed PK cohort (Study B).
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Praxis Bioresearch, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Kore Liow, MD, Principal investigator, Hawaii Pacific Neuroscience
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04638803
- Sponsor's protocol ID
- PBR001
- Other IDs
- R44MH116764
- Status last verified
- Sep 2026
- First submitted
- 4 Nov 2020
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 0, Open-Label, Crossover Microdose Pharmacokinetic Study of Prodrug PRX-P4-003 in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT04638803
- Acronym / sponsor ID
- PBR001
- Conditions
- Healthy
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Praxis Bioresearch, LLCIndustry (pharma, biotech, devices)
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 25 Feb 2021 (actual)
- Primary completion
- 30 Oct 2021 (actual)
- Study completion
- 31 Oct 2021 (actual)
- First posted
- 20 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase 0, open-label, crossover microdose pharmacokinetic study of PRX-P4-003 in healthy volunteers.
Detailed description
This study will evaluate the pharmacokinetics of a single oral microdose of PRX-P4-003 in healthy male volunteers in a fasted state (Study A) and a fed state (Study B).
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Fasted crossover comparison of PRX-P4-003 and (-)-fencamfamine (Study A) plus a fed PK cohort (Study B).
| Arm | Type | Receives |
|---|---|---|
| PRX-P4-003 - Fasted | Experimental | Drug: PRX-P4-003Single 100 µg oral microdose of PRX-P4-003 administered under fasted conditions. |
| (-)-FCF - Fasted | Experimental | Drug: (-)-FCFSingle 40 µg oral dose of (-)-fencamfamine hydrochloride [(-)-FCF HCl] administered under fasted conditions. |
| PRX-P4-003 - Fed | Experimental | Drug: PRX-P4-003Single 100 µg oral microdose of PRX-P4-003 administered under fed conditions. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Healthy male volunteers aged 18 to 45 years
- Body Mass Index (BMI) between 18 and 32 kg/m² (inclusive)
- Normal resting heart rate (50 to 100 bpm) and blood pressure (systolic 90-130 mmHg, diastolic 60-85 mmHg) at Screening and Day 0
- Willingness to provide written informed consent and HIPAA authorization, and agreement to use a highly effective method of birth control during the study and for 1 month after study drug administration
- Nonsmoker (no smoking within 6 months of Screening Visit 1); no medicinal or recreational marijuana use within 3 months prior to screening or during the study
Key exclusion criteria (12 listed)
- History or presence of any clinically significant respiratory, gastrointestinal, renal, hepatic, hematological, neurological (including seizure history), cardiovascular, psychiatric (including known addictive disorders), musculoskeletal, genitourinary, immunological, or dermatological disorders
- History of suicide attempts or current suicidal ideation
- Clinically significant abnormal physical, neurological, or laboratory findings, or abnormal ECG (including average QTc interval ≥ 450 msec or a history of congenitally prolonged QT interval)
- Need for prescription medications within 14 days (or 5 half-lives) prior to dosing
- Acetaminophen use > 1000 mg (single dose) within 3 days prior to Day 1
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PRX-P4-003100 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 | PRX-P4-003 - Fasted, PRX-P4-003 - Fed |
| (-)-FCFAlso: (-)-fencamfamine hydrochloride, (-)-FCF HCl40 µg single oral dose dissolved in 8 oz (240 mL) of water as a liquid solution. | Drug | (-)-FCF - Fasted |
Primary outcome
Systemic Exposure (AUC0-t) of Active (-)-fencamfamine [(-)-FCF]
Time frame: Up to 24 hours post-dose (pre-dose [15-30 minutes prior], and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 9, 12, and 24 hours post-dose)
Determination of the average exposure of active (-)-fencamfamine [(-)-FCF], as measured by the Area Under the plasma concentration-time Curve to the last measurable concentration (AUC0-t), following single oral microdose administration of PRX-P4-003 (100 µg) and the reference drug (-)-FCF HCl (40 µg).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Healthy
Not yet recruitingPhase 1
Dynamic Magnetic Resonance Imaging of Human Subarachnoid Space Using Intrathecal Gadolinium Contrast
Healthy Volunteers
RecruitingObservational study
Survey to Determine Incarcerated Persons' Views on Surrogate Decision Making
Healthy Volunteers
Active, not recruitingPhase 1
A Study to Learn How Different Amounts of the Study Medicine Called PF-07985631 Are Tolerated and Act in the Body of Healthy Adults
Healthy
Not yet recruitingObservational study
Collection and Distribution of Blood Components From Healthy Donors for In Vitro Research Use
Blood Donors, Apheresis
Recruiting
Metabolic Impact of VLCPUFA-Rich Fish Oil: A Clinical Study on Omega-3 Index Enhancement in Healthy Individuals
Fatty Acids, Omega-3, Fish Oils
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kore Liow, MD principal investigator
Hawaii Pacific Neuroscience
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing PRX-P4-003 and (-)-FCF in people with Healthy, run by Praxis Bioresearch, LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Systemic Exposure (AUC0-t) of Active (-)-fencamfamine [(-)-FCF] (time frame: Up to 24 hours post-dose (pre-dose [15-30 minutes prior], and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 9, 12, and 24 hours post-dose)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.