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Will a tablet deliver the same dose as a capsule? a bioavailability showdown

NCT ID NCT06840925

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 03, 2026 · Last updated Aug 04, 2026 · Updated 1 time

Summary

This trial is testing whether a new tablet form of the experimental drug PRAX-628 is absorbed by the body as well as the existing capsule form. Healthy volunteers will receive a single 40 mg dose of each version on separate occasions, and researchers will compare drug levels in the blood. The goal is to see if the tablet can be used interchangeably with the capsule in future studies.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
PRAX-628
What this could lead to
If the tablet is absorbed as well as the capsule, it could offer a more convenient or cost-effective way to take this drug in future studies or treatments.
What could go wrong
This is an early-stage trial with only 16 healthy people, so results may not predict effects in patients. The tablet might not be absorbed as well as the capsule, and side effects are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

16 people

The number who actually took part.

Started

Apr 2025

Finished

Jun 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 55 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 Exclusion Criteria: * 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): 1. History of inflammatory bowel syndrome, gastritis, gastrointestinal or rectal bleeding 2. History of major gastrointestinal tract surgery (ie, gastrectomy, bowel resection, cholecystectomy etc.) 3. 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) * 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

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Nucleus Network Melbourne

    Melbourne, Victoria, 3004, Australia

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