A Trial in Healthy Participants to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of PRAX-944

Phase 1

Completed

• Conditions: Essential Tremor; Neurological - Other neurological disorders

• Registration Number: ACTRN12620000675921
• Lead Sponsor: Praxis Precision Medicines

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-06-12
• Study Completion: 2020-09-06
• Last Update Posted: 7 March 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

Female or male and between the ages of 18 and 55 years, inclusive.
- Weight of at least 50 kg with body mass index (BMI) between 18 and 32 kg/m2 (inclusive).

Exclusion Criteria

- Ongoing or history of any psychiatric, medical or surgical condition that might jeopardize the participant’s safety or interfere with the absorption, distribution, metabolism or excretion of the study drug.
- Any abnormal ECG, laboratory value or physical examination
- Positive breath test for ethanol, urine drug screen, urine cotinine test
- Use of systemic prescription medications or over-the-counter (OTC) medication, including multivitamins, and dietary and herbal supplement within 2 weeks
- Use of any experimental or investigational drug or device within 30 days
- Donation or loss of greater than or equal to 400 mL blood within 8 weeks and/or donation of plasma within 7 days

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Part A: Evaluate the pharmacodynamic effects of PRAX-944 as assessed by changes in EEG.[Part A: Baseline, Day 1, Day 4, Day 5, Day 8, Day 9 Day 12 and Day 13];Part B: Safety and tolerability of PRAX-944 as assessed through an integrated analysis of the following endpoints: patient and clinician-reported adverse events, physical exams, vital signs, clinical laboratory results, electrocardiogram (ECG) and Columbia-Suicide Severity Rating Scale (C-SSRS)[Part B: Baseline, Day 1 to Day 33, Day 36]

Secondary Outcome Measures

Name	Time	Method
Part A and Part B: Pharmacokinetics will be performed by LC/MS quantification of PRAX-944 levels in plasma. Parameters include plasma concentrations (Cmax, tmax, t1/2) and accumulation ratios (AUC).[Part A and Part B: pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours post-dose];Part A: Safety and tolerability of PRAX-944 as assessed through an integrated analysis of the following endpoints: patient and clinician-reported adverse events, physical exams, vital signs, clinical laboratory results, electrocardiogram (ECG) and Columbia-Suicide Severity Rating Scale (C-SSRS),[Part A: Baseline, Day 1 to Day 13, Day 17]