CompletedPhase 1ACTRN12620001292965

A Trial in Healthy Participants to Evaluate the Pharmacokinetics, Safety, Tolerability and Food Effects of PRAX-562

A Phase 1, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Doses and Food Effect of PRAX-562 in Healthy Volunteers

Sponsor

Praxis Precision Medicines

Enrollment

120 participants

Start Date

Jun 19, 2020

Study Type

Interventional

Conditions

Epilepsy

Summary

This clinical trial is to evaluate the PK, safety, tolerability and food effects of PRAX-562 in healthy participants aged 18 to 55 years inclusive.

Eligibility

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

Inclusion Criteria3

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 30 kg/m2 (inclusive).
Medically healthy (without significant medical issues, e.g. high blood pressure)

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 findings, laboratory value or physical examination findings
Positive ethanol, drug screen or 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 400 mL or more of blood within 8 weeks and/or donation of plasma within 7 days

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

Participants will be confined at the site during the dosing period where dosing will be done via direct supervision and they can only participate in one of the following parts: - Part A (oral capsule

Participants will be confined at the site during the dosing period where dosing will be done via direct supervision and they can only participate in one of the following parts: - Part A (oral capsule; screening/ baseline period of up to 28 days with total duration up to 39 days): single ascending doses of PRAX-562 between 2.5 mg and 90 mg (increases of no more than 3 times the previous dose will be based on safety and tolerability at each dose level) or placebo (Day 1) administered under fasting conditions - Part B (oral capsule; screening/ baseline period of up to 28 days with total duration up to 47 days): single daily doses of up to 90 mg PRAX-562* or placebo (Day 1-14) administered under fasting conditions - Part C (oral capsule; screening/ baseline period of up to 28 days with total duration up to 50 days): up to 90 mg PRAX-562* (Day 1 and 8) both fasted (no food or drink, except water, for at least 10 hours prior to dosing) and fed (30 minutes after a high-fat, high-calorie meal where approximately 50% of the calories will be from fat) in a randomized order *Exact dose of PRAX-562 for Parts B and C will be based on safety, tolerability and PK data from Part A