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

ConditionHealthy
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-55
SponsorPraxis Precision Medicines

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

Any clinically significant abnormalities, medical, or psychiatric conditions identified by a detailed medical history, or physical examination

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

Trial design

Design model

Crossover

Treatments tested in this trial

  • PRAX-628

    Drug

    Once daily oral

Treatment groups

16 Participants
are divided into 2 treatment groups
Group A: Single Oral Dose 40mg PRAX-628 tablet then 4x10mg PRAX-628 capsulesExperimental treatment 1 intervention
Group B: Single Oral Dose 4x10mg PRAX-628 capsules then 40mg PRAX-628 tabletExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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)

Time frame
28 days
2

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)

Time frame
28 days

Secondary outcomes

1

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)

Time frame
28 days
2

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)

Time frame
28 days
3

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)

Time frame
28 days
4

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)

Time frame
32 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Praxis Precision Medicines

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: