CompletedPhase 1ACTRN12620000675921

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

A Phase 1 Clinical Trial in Healthy Participants to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of PRAX-944 Administered in a Within-Participant Escalating Dose Paradigm

Sponsor

Praxis Precision Medicines

Enrollment

24 participants

Start Date

May 29, 2020

Study Type

Interventional

Conditions

Essential Tremor

Summary

This single-center, two-part, Phase 1 clinical trial will assess the safety, tolerability, pharmacokinetics (PK) and PD of multiple-ascending doses of PRAX-944 in healthy male and female participants aged 18 to 55 years, inclusive.

Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 55 Yearss

Inclusion Criteria2

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 Criteria6

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

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Interventions

Participants will be confined at the site during the dosing period and all dosing will be witnessed by study staff. Part B will only commence once the safety of PRAX-944 low doses is established in P

Participants will be confined at the site during the dosing period and all dosing will be witnessed by study staff. Part B will only commence once the safety of PRAX-944 low doses is established in Part A. Participants can only take part in either Part A or Part B of the study: - Part A (PRAX-944 oral tablet): 5mg (Day 1-4); 10mg (Day 5-8); 20mg (Day 9-12) - Part B (PRAX-944 oral tablet): 20mg (Day 1-3); 40mg (Day 4-6); 60mg (Day 7-13); 80mg (Day 14-20); 100mg (Day 21-27); 120mg (Day 28-31) or placebo (Day 1-31)