HealthyPhase 1NCT06840925
A Clinical Trial to Evaluate the Relative Bioavailability of PRAX-628
A Phase 1 study testing PRAX-628 in people with Healthy, run by Praxis Precision Medicines at 1 site in Australia.
Trial summary
A phase I clinical trial to evaluate the relative bioavailability of PRAX-628 tablet formulation compared to capsule formulation Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- PRAX-628
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteAustralia
- Study dates
- 28 Apr 2025to 5 Jun 2025
- Phase
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Weight of at least 50 kg with body mass index (BMI) between 18 and 32 kg/m2
- Is in good health, determined by no clinically significant findings from medical history, physical examination, 12-lead ECG, vital signs measurements, and clinical laboratory evaluations
- All females have a negative pregnancy test and are not planning to get pregnant for the duration of the trial
- Female of non-childbearing potential by reason of surgery or at least 1 year post menopause
- Additional inclusion criteria apply and will be assessed by the study team
Who cannot join
- Any clinically significant abnormalities, medical, or psychiatric conditions identified by a detailed medical history, or physical examination
- Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of drugs. Examples of such conditions include (but are not limited to):
- History of inflammatory bowel syndrome, gastritis, gastrointestinal or rectal bleeding
- History of major gastrointestinal tract surgery (ie, gastrectomy, bowel resection, cholecystectomy etc.)
- History or evidence of pancreatic injury or pancreatitis
- History or presence of impaired renal function supported by estimated glomerular filtration rate [eGFR]<60 mL/min/1.73m2 or clinically significant abnormal urinary constituents (eg, protein)
Show all 19Show fewer
- History of cancer except for nonmelanoma skin cancer resected >2 years ago and that has been definitively treated and considered cured.
- History of any lifetime suicide attempt or active suicidal ideation with intent as indicated by a "Yes" response to either Question 4 or 5 on the C-SSRS "Baseline/ Screening" version
- History of left bundle branch block, arrhythmias, Brugada syndrome, congenital heart disease, familial short QT syndrome, or family (first degree relative) history of sudden death, ventricular or clinically significant arrhythmias, including idiopathic ventricular fibrillation.
- Abnormal standard 12-lead ECG after at least 5 minutes resting in the supine position
- Abnormal vital signs after at least 5 minutes resting in the supine position:
- Has any of the following: a serum total bilirubin value >1.1× the upper limit of normal (ULN), a serum alanine aminotransferase (ALT) value >1.5×ULN, or aspartate aminotransferase (AST) value >1.5×ULN
- Serology test positive for human immunodeficiency virus (HIV), or hepatitis B or C
- Known allergy or hypersensitivity to any component of the formulation of PRAX 628 or history of severe allergy or anaphylaxis to a drug, food, or other exposure
- Use of any experimental or investigational drug or device within 30 days prior to the first dose of study drug or 5 times the terminal half-life of the drug, whichever is longer
- Use of systemic prescription medications; or over-the-counter medication, including multivitamins; and dietary and herbal supplements within 2 weeks or 5 times the terminal half-life of the medication prior to the first dose of study drug (whichever is longer) and for the duration of the trial
- Donation of blood within 1 month prior to Screening, plasma within 1 week prior to Screening, or platelets within 6 weeks prior to Screening
- Any vaccination within 28 days of the first dose of study drug
- Additional exclusion criteria apply and will be assessed by the study team
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Randomized, Open-Label, 2-Way Crossover Clinical Trial in Healthy Participants to Evaluate the Relative Bioavailability of PRAX-628 Tablet Formulation Compared to Capsule Formulation
A phase I clinical trial to evaluate the relative bioavailability of PRAX-628 tablet formulation compared to capsule formulation
Read the detailed description
This Phase 1, randomized, open-label, 2-way crossover clinical trial is designed to investigate the relative bioavailability, pharmacokinetics (PK), safety, and tolerability of PRAX628 tablet formulation and PRAX-628 capsule formulation in healthy male or female participants.
- Conditions
- Healthy
- Being tested
- PRAX-628
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRAX-628Drug
Once daily oral
| Study group | Role | What they receive |
|---|---|---|
| Single Oral Dose 40mg PRAX-628 tablet then 4x10mg PRAX-628 capsules | Experimental | 40 mg PRAX-628 tablet followed by 4×10 mg PRAX-628 capsules administered orally. Receives: Drug: PRAX-628 |
| Single Oral Dose 4x10mg PRAX-628 capsules then 40mg PRAX-628 tablet | Experimental | 4×10 mg PRAX-628 capsules followed by 40 mg PRAX-628 tablet administered orally. Receives: Drug: PRAX-628 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the relative bioavailability of single 40 mg oral doses of PRAX-628 tablet as compared to PRAX-628 capsules
Geometric mean ratio (90% CI) for maximum observed plasma concentration (Cmax)
Measured: 28 days
To assess the relative bioavailability of single 40 mg oral doses of PRAX-628 tablet as compared to PRAX-628 capsules
Area under the plasma concentration time curve from time zero to infinity (AUCinf) of a single dose of PRAX-628 40 mg tablet (test), and the same dose delivered with PRAX-628 10 mg capsules (reference)
Measured: 28 days
Secondary outcomes (11)
To evaluate the pharmacokinetics (PK) of single 40 mg oral doses of PRAX-628 tablet and PRAX-628 capsules
Plasma concentrations of PRAX-628 (Cmax)
Measured: 28 days
To evaluate the pharmacokinetics (PK) of single 40 mg oral doses of PRAX-628 tablet and PRAX-628 capsules
Time to maximum plasma drug concentration (tmax)
Measured: 28 days
To evaluate the pharmacokinetics (PK) of single 40 mg oral doses of PRAX-628 tablet and PRAX-628 capsules
Area under the plasma concentration versus time curve (AUC)
Measured: 28 days
To evaluate the safety and tolerability of single 40 mg oral doses of PRAX-628 tablet and PRAX-628 capsules
Incidence and severity of adverse events (AEs)
Measured: 32 days
To evaluate the safety and tolerability of single 40 mg oral doses of PRAX-628 tablet and PRAX-628 capsules
Change in tympanic temperature in Celsius
Measured: 32 days
To evaluate the safety and tolerability of single 40 mg oral doses of PRAX-628 tablet and PRAX-628 capsules
Change in heart rate in beats per minute
Measured: 32 days
To evaluate the safety and tolerability of single 40 mg oral doses of PRAX-628 tablet and PRAX-628 capsules
Change in blood pressure in mm/Hg
Measured: 32 days
To evaluate the safety and tolerability of single 40 mg oral doses of PRAX-628 tablet and PRAX 628 capsules
Change in respiratory rate in breaths per minute
Measured: 32 days
Number of Participants With Clinically Significant Changes in Chemistry parameters
The principal investigator (PI) or sub investigator will review the laboratory report and document this review. Any clinically significant adverse changes occurring during the clinical trial will be documented as adverse events.
Measured: 32 days
Number of Participants With Clinically Significant Changes in Hematology parameters
The principal investigator (PI) or sub investigator will review the laboratory report and document this review. Any clinically significant adverse changes occurring during the clinical trial will be documented as adverse events.
Measured: 32 days
Number of Participants With Clinically Significant Changes in Urinalysis
The Princpal investigatort (PI) or sub investigator will review the laboratory report and document this review. Any clinically significant adverse changes occurring during the clinical trial will be documented as adverse events.
Measured: 32 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2025
- Study start28 Apr 2025
- Primary completion5 Jun 2025
- Study completion5 Jun 2025
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
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Praxis Precision Medicines
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Director, Clinical Development, Study director, Praxis Precision Medicines
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06840925
- Sponsor's protocol ID
- PRAX-628-104
- Status last verified
- Jul 2026
- First submitted
- 29 Jan 2025
- Last updated
- 3 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Open-Label, 2-Way Crossover Clinical Trial in Healthy Participants to Evaluate the Relative Bioavailability of PRAX-628 Tablet Formulation Compared to Capsule Formulation
- ClinicalTrials.gov ID
- NCT06840925
- Acronym / sponsor ID
- PRAX-628-104
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Praxis Precision MedicinesIndustry (pharma, biotech, devices)
- Study start
- 28 Apr 2025 (actual)
- Primary completion
- 5 Jun 2025 (actual)
- Study completion
- 5 Jun 2025 (actual)
- First posted
- 21 Feb 2025 (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.
A phase I clinical trial to evaluate the relative bioavailability of PRAX-628 tablet formulation compared to capsule formulation
Detailed description
This Phase 1, randomized, open-label, 2-way crossover clinical trial is designed to investigate the relative bioavailability, pharmacokinetics (PK), safety, and tolerability of PRAX628 tablet formulation and PRAX-628 capsule formulation in healthy male or female participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single Oral Dose 40mg PRAX-628 tablet then 4x10mg PRAX-628 capsules | Experimental | Drug: PRAX-62840 mg PRAX-628 tablet followed by 4×10 mg PRAX-628 capsules administered orally. |
| Single Oral Dose 4x10mg PRAX-628 capsules then 40mg PRAX-628 tablet | Experimental | Drug: PRAX-6284×10 mg PRAX-628 capsules followed by 40 mg PRAX-628 tablet administered orally. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Weight of at least 50 kg with body mass index (BMI) between 18 and 32 kg/m2
- Is in good health, determined by no clinically significant findings from medical history, physical examination, 12-lead ECG, vital signs measurements, and clinical laboratory evaluations
- All females have a negative pregnancy test and are not planning to get pregnant for the duration of the trial
- Female of non-childbearing potential by reason of surgery or at least 1 year post menopause
- Additional inclusion criteria apply and will be assessed by the study team
Key exclusion criteria (19 listed)
- Any clinically significant abnormalities, medical, or psychiatric conditions identified by a detailed medical history, or physical examination
- Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of drugs. Examples of such conditions include (but are not limited to):
- History or presence of impaired renal function supported by estimated glomerular filtration rate [eGFR]<60 mL/min/1.73m2 or clinically significant abnormal urinary constituents (eg, protein)
- History of cancer except for nonmelanoma skin cancer resected >2 years ago and that has been definitively treated and considered cured.
- History of any lifetime suicide attempt or active suicidal ideation with intent as indicated by a "Yes" response to either Question 4 or 5 on the C-SSRS "Baseline/ Screening" version
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 |
|---|---|---|
| PRAX-628Once daily oral | Drug | Single Oral Dose 40mg PRAX-628 tablet then 4x10mg PRAX-628 capsules, Single Oral Dose 4x10mg PRAX-628 capsules then 40mg PRAX-628 tablet |
Primary outcome
To assess the relative bioavailability of single 40 mg oral doses of PRAX-628 tablet as compared to PRAX-628 capsules
Time frame: 28 days
Geometric mean ratio (90% CI) for maximum observed plasma concentration (Cmax)
To assess the relative bioavailability of single 40 mg oral doses of PRAX-628 tablet as compared to PRAX-628 capsules
Time frame: 28 days
Area under the plasma concentration time curve from time zero to infinity (AUCinf) of a single dose of PRAX-628 40 mg tablet (test), and the same dose delivered with PRAX-628 10 mg capsules (reference)
11 secondary outcomes
To evaluate the pharmacokinetics (PK) of single 40 mg oral doses of PRAX-628 tablet and PRAX-628 capsules
Time frame: 28 days
To evaluate the pharmacokinetics (PK) of single 40 mg oral doses of PRAX-628 tablet and PRAX-628 capsules
Time frame: 28 days
To evaluate the pharmacokinetics (PK) of single 40 mg oral doses of PRAX-628 tablet and PRAX-628 capsules
Time frame: 28 days
To evaluate the safety and tolerability of single 40 mg oral doses of PRAX-628 tablet and PRAX-628 capsules
Time frame: 32 days
To evaluate the safety and tolerability of single 40 mg oral doses of PRAX-628 tablet and PRAX-628 capsules
Time frame: 32 days
To evaluate the safety and tolerability of single 40 mg oral doses of PRAX-628 tablet and PRAX-628 capsules
Time frame: 32 days
To evaluate the safety and tolerability of single 40 mg oral doses of PRAX-628 tablet and PRAX-628 capsules
Time frame: 32 days
To evaluate the safety and tolerability of single 40 mg oral doses of PRAX-628 tablet and PRAX 628 capsules
Time frame: 32 days
Number of Participants With Clinically Significant Changes in Chemistry parameters
Time frame: 32 days
Number of Participants With Clinically Significant Changes in Hematology parameters
Time frame: 32 days
Number of Participants With Clinically Significant Changes in Urinalysis
Time frame: 32 days
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 3 Aug 2026.
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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.
Director, Clinical Development study director
Praxis Precision Medicines
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PRAX-628 in people with Healthy, run by Praxis Precision Medicines at 1 site in Australia.
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 5 inclusion and 19 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 3 Aug 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 Australia. 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?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
To assess the relative bioavailability of single 40 mg oral doses of PRAX-628 tablet as compared to PRAX-628 capsules (time frame: 28 days). The study lists 2 primary outcomes in all. 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 3 Aug 2026.