None listed
Conditions
Brief summary
This clinical trial is to evaluate the PK, safety, tolerability and food effects of oral suspension and solid dosage formulations of PRAX-114 in healthy participants aged 18 to 55 years inclusive.
Interventions
Participants will be confined at the site during the dosing period and can only participate in one of the following parts:
Part A-1 (oral suspension): 45 mg PRAX-114 (Day 1 and 6); 60 mg PRAX-114 (Day 11 and 16)
Part A-2 (oral tablet): up to 80 mg PRAX-114 (Day 1 and 6) and up to 120 mg (Day 11 and 16).
Part B (oral tablet): up to 80 mg PRAX-114 (Day 1 and 6) 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 mea
Participants will be confined at the site during the dosing period and can only participate in one of the following parts: Part A-1 (oral suspension): 45 mg PRAX-114 (Day 1 and 6); 60 mg PRAX-114 (Day 11 and 16) Part A-2 (oral tablet): up to 80 mg PRAX-114 (Day 1 and 6) and up to 120 mg (Day 11 and 16). Part B (oral tablet): up to 80 mg PRAX-114 (Day 1 and 6) 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) in a randomized order Part C (oral tablet): up to 40 mg PRAX-114 or placebo (Day 1), up to 80 mg PRAX-114 or placebo (Day 9), up to 100 mg PRAX-114 or placebo (Day 17), up to 120 mg PRAX-114 or placebo (Day 25 and 33) Part D (oral tablet): up to 120 mg PRAX-114 or placebo (Day 1-14) *Exact dose of PRAX-114 for Parts A-2, B, C and D will be based on data from previous parts and/ or dosing periods
Sponsors
Praxis Precision Medicines Australia, Pty Ltd
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Healthy volunteers
Yes
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 30 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 findings, laboratory value or physical examination findings - 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 =400 mL blood within 8 weeks and/or donation of plasma within 7 days
Outcome results
None listed