A study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple ascending doses of PRAX-628 in healthy participants
- Conditions
- PRAX-628 is a new investigational drug that is being developed as part of the treatment of epilepsy.Not Applicable
- Registration Number
- ISRCTN95162082
- Lead Sponsor
- Praxis Precision Medicines
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 112
1. Willing and able to provide informed consent indicating that they understand the purpose of the clinical trial and the procedures that are required for the clinical trial, and that they are willing to comply with scheduled visits, and all study related procedures.
2. Male or female between the ages of 18 and 55 years, inclusive.
3. Body mass index (BMI) of 18.0 to 32.0 kg/m², inclusive, and a total body weight of at least 50 kg.
4. Females of childbearing potential are not pregnant or breast-feeding, have a negative serum pregnancy test at Screening and a negative urine pregnancy test at Baseline and are not planning to get pregnant for the duration of the trial.
5.1. Female of nonchildbearing potential by reason of surgery or at least 1 year postmenopausal (ie, 12 months since last menses) with confirmation by follicle stimulating hormone (FSH) at Screening only, or
5.2. Female of childbearing potential who is willing to use a highly effective method or methods of contraception as defined in this protocol and for the duration prescribed in this protocol, or
5.3. Male who is willing and able to use a highly effective method or methods of contraception as defined in this protocol and for the duration prescribed in this protocol.
1. Any clinically significant abnormalities, medical, or psychiatric conditions identified by a detailed medical history,or physical examination, that in the opinion of the investigator would pose an additional safety risk to theparticipant or compromise the objectives of the study.
2. A history or cardiac disease(s)/cardiac conduction disorders/or cardiac structural abnormality(ies) (e.g., atrial orventricular septal defects, valvular heart disease, coarctation of the aorta, or hypertrophic obstructivecardiomyopathy).
3. Has a history of any lifetime suicide attempt or active suicidal ideation as confirmed by C-SSRS BaselineVersion.
4. Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, orexcretion of drugs or which may jeopardize the participant in case of participation in the study.
5. Abnormal vital signs after at least 5 minutes resting in the supine position.
6. Abnormal standard 12-lead ECG after at least 5 minutes resting in the supine position.
7. Any finding that, in the judgement of the investigator, is a clinically significant abnormality, including serumchemistry, hematology, coagulation, and urinalysis test values (abnormal test results may be repeated forconfirmation).
8. An elevation of =1.5× ULN for AST or ALT/ serum glutamic pyruvic transaminase (SGPT) or =2×ULN for totalbilirubin.
9. Positive test for HIV, hepatitis B (HBsAg), or hepatitis C.
10. History of drug or alcohol abuse.
11. Positive drug or alcohol test at Screening or Baseline. (Abnormal test results may be repeated forconfirmation).
12. Smoker (use of tobacco or nicotine-containing products in the previous 3 months) or evidence of such use asindicated by cotinine testing at Screening and Baseline.
13. Use of an investigational drug or device within 90 days or 5 half-lives preceding the first dose of study drug,whichever is longer.
14. Use of prescription or nonprescription drugs or dietary or herbal supplements of clinical concern within 7 daysor within 5 times the elimination half-life (whichever is longer) prior to the first dose of study drug. Refer to therelevant section(s) of the protocol for potential exceptions which must be approved by the sponsor/designee.
15. Inability to abstain from eating or drinking grapefruit or grapefruit-related citrus fruits (eg, Seville oranges,pomelos) from 7 days prior to the first dose of study drug until collection of the final PK blood sample.
16. Any vaccination within 14 days of the first dose of study drug.
17. Blood donation (excluding plasma donations) or significant blood loss of approximately 500 mL or more within 90 days (male) or 120 days (female) prior to first dose of study drug.
18. Presence or history of any allergy or hypersensitivity to any component of the study drug product , or history of severe allergy or anaphylaxis to a drug, food, or other exposure.
19. Unwilling or unable to comply with the lifestyle considerations described in this protocol.
20. An employee or family member of an employee of the sponsor, or an employee or family member of the study site staff.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method