NL-OMON51482
Recruiting
Not Applicable
A Phase 1, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Ascending Doses of PRAX-628 in Healthy Participants. - PRAX-628 in HV
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Focal epilepsy
- Sponsor
- Praxis Precision Medicines
- Enrollment
- 112
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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 studyrelated 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.
Exclusion Criteria
- •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 the
- •participant or compromise the objectives of the study.
- •2\. A history of cardiac disease(s)/cardiac conduction disorders/or cardiac
- •structural abnormality(ies) (e.g., atrial or ventricular septal defects,
- •valvular heart disease, coarctation of the aorta, or hypertrophic obstructive
- •cardiomyopathy).
- •3\. Has a history of any lifetime suicide attempt or active suicidal ideation as
- •confirmed by C\-SSRS Baseline Version (Part B only).
Outcomes
Primary Outcomes
Not specified
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