OverviewStudy detailsEligibilityThings to knowResearchStudy plan
info
Simplify with AI

A Clinical Trial to Evaluate the Relative Bioavailability of PRAX-628

PHASE1COMPLETED

A phase I clinical trial to evaluate the relative bioavailability of PRAX-628 tablet formulation compared to capsule formulation.

Study details:

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.

Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

Inclusion criteria

  1. Weight of at least 50 kg with body mass index (BMI) between 18 and 32 kg/m2
  2. 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
  3. All females have a negative pregnancy test and are not planning to get pregnant for the duration of the trial
  4. Female of non-childbearing potential by reason of surgery or at least 1 year post menopause
  5. Additional inclusion criteria apply and will be assessed by the study team

Exclusion criteria

  1. Any clinically significant abnormalities, medical, or psychiatric conditions identified by a detailed medical history, or physical examination
  2. 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):
  3. History of inflammatory bowel syndrome, gastritis, gastrointestinal or rectal bleeding
  4. History of major gastrointestinal tract surgery (ie, gastrectomy, bowel resection, cholecystectomy etc.)
  5. History or evidence of pancreatic injury or pancreatitis
  6. 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)
  7. History of cancer except for nonmelanoma skin cancer resected >2 years ago and that has been definitively treated and considered cured.
  8. 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
  9. 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.
  10. Abnormal standard 12-lead ECG after at least 5 minutes resting in the supine position
  11. Abnormal vital signs after at least 5 minutes resting in the supine position:
  12. 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
  13. Serology test positive for human immunodeficiency virus (HIV), or hepatitis B or C
  14. 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
  15. 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
  16. 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
  17. Donation of blood within 1 month prior to Screening, plasma within 1 week prior to Screening, or platelets within 6 weeks prior to Screening
  18. Any vaccination within 28 days of the first dose of study drug
  19. Additional exclusion criteria apply and will be assessed by the study team

Eligibility

Age eligible for study : NA

Healthy volunteers accepted : No

Gender eligible for study: FEMALE

Things to know

Study dates

Study start:

Primary completion:

Study completion finish:

study type

Study type

TREATMENT

phase

Phase

    PHASE1

trial

Study ID

NCT06840925

Intervention or treatment

DRUG: PRAX-628

Conditions

  • Healthy

  • Condition: Healthy

  • DRUG: PRAX-628

  • Melbourne, Victoria, Australia

  • Sponsor: Praxis Precision Medicines

Save

Share

You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.

Are you running this trial?

If you're a clinic or sponsor, you can claim this study

Research sites nearby

Closest Location:

Nucleus Network Melbourne

Select from list below to view details:

  • Nucleus Network Melbourne

    Melbourne, Victoria, Australia

Loading map...

Who is running the clinical trial?

PPM

Praxis Precision Medicines

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/ArmIntervention/Treatment
EXPERIMENTAL: Single Oral Dose 40mg PRAX-628 tablet then 4x10mg PRAX-628 capsules
  • 40 mg PRAX-628 tablet followed by 4×10 mg PRAX-628 capsules administered orally.
Drug: PRAX-628
    EXPERIMENTAL: Single Oral Dose 4x10mg PRAX-628 capsules then 40mg PRAX-628 tablet
    • 4×10 mg PRAX-628 capsules followed by 40 mg PRAX-628 tablet administered orally.
    Drug: PRAX-628

      What is the study measuring?

      Primary Outcome

      MeasureDescriptionTime Frame
      To assess the relative bioavailability of single 40 mg oral doses of PRAX-628 tablet as compared to PRAX-628 capsulesGeometric mean ratio (90% CI) for maximum observed plasma concentration (Cmax)28 days
      To assess the relative bioavailability of single 40 mg oral doses of PRAX-628 tablet as compared to PRAX-628 capsulesArea 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)28 days

      Secondary Outcome

      MeasureDescriptionTime Frame
      To evaluate the pharmacokinetics (PK) of single 40 mg oral doses of PRAX-628 tablet and PRAX-628 capsulesPlasma concentrations of PRAX-628 (Cmax)28 days
      To evaluate the pharmacokinetics (PK) of single 40 mg oral doses of PRAX-628 tablet and PRAX-628 capsulesTime to maximum plasma drug concentration (tmax)28 days
      To evaluate the pharmacokinetics (PK) of single 40 mg oral doses of PRAX-628 tablet and PRAX-628 capsulesArea under the plasma concentration versus time curve (AUC)28 days
      To evaluate the safety and tolerability of single 40 mg oral doses of PRAX-628 tablet and PRAX-628 capsulesIncidence and severity of adverse events (AEs)32 days
      To evaluate the safety and tolerability of single 40 mg oral doses of PRAX-628 tablet and PRAX-628 capsulesChange in tympanic temperature in Celsius32 days
      To evaluate the safety and tolerability of single 40 mg oral doses of PRAX-628 tablet and PRAX-628 capsulesChange in heart rate in beats per minute32 days
      To evaluate the safety and tolerability of single 40 mg oral doses of PRAX-628 tablet and PRAX-628 capsulesChange in blood pressure in mm/Hg32 days
      To evaluate the safety and tolerability of single 40 mg oral doses of PRAX-628 tablet and PRAX 628 capsulesChange in respiratory rate in breaths per minute32 days
      Number of Participants With Clinically Significant Changes in Chemistry parametersThe 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.32 days
      Number of Participants With Clinically Significant Changes in Hematology parametersThe 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.32 days
      Number of Participants With Clinically Significant Changes in UrinalysisThe 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.32 days
      Are you running this trial?If you're a clinic or sponsor, you can claim this study.
      Claim this trial

      References

      Clinical Trials Gov: A Clinical Trial to Evaluate the Relative Bioavailability of PRAX-628

      Other trials to consider

      Loading suggested trials...

      Top searched conditions

      Breast CancerLung CancerType 2 DiabetesDermatitisAlzheimersParkinsonsLupusCrohn’s DiseaseAsthmaHypertensionCOPDMultiple SclerosisOsteoarthritisHIV/AIDSPsoriasisStrokeObesityProstate CancerDepressionCardiovascular