Healthy
Conditions
Brief summary
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.
Interventions
DRUGPRAX-628
Once daily oral
Sponsors
Praxis Precision Medicines
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To assess the relative bioavailability of single 40 mg oral doses of PRAX-628 tablet as compared to PRAX-628 capsules | 28 days | Geometric mean ratio (90% CI) for maximum observed plasma concentration (Cmax) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To evaluate the pharmacokinetics (PK) of single 40 mg oral doses of PRAX-628 tablet and PRAX-628 capsules | 28 days | Plasma concentrations of PRAX-628 (Cmax) |
| To evaluate the safety and tolerability of single 40 mg oral doses of PRAX-628 tablet and PRAX-628 capsules | 32 days | Incidence and severity of adverse events (AEs) |
| To evaluate the safety and tolerability of single 40 mg oral doses of PRAX-628 tablet and PRAX 628 capsules | 32 days | Change in respiratory rate in breaths per minute |
| Number of Participants With Clinically Significant Changes in Chemistry parameters | 32 days | 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. |
| Number of Participants With Clinically Significant Changes in Hematology parameters | 32 days | 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. |
| Number of Participants With Clinically Significant Changes in Urinalysis | 32 days | 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. |
Countries
Australia
Contacts
STUDY_DIRECTORDirector, Clinical Development
Praxis Precision Medicines
Outcome results
None listed