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Trial registered on ANZCTR


Registration number
ACTRN12620000522910
Ethics application status
Approved
Date submitted
31/01/2020
Date registered
28/04/2020
Date last updated
7/08/2020
Date data sharing statement initially provided
28/04/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
A Trial in Healthy Participants to Evaluate the Pharmacokinetics, Safety, Tolerability and Food Effects of Multiple Forms of PRAX-114.
Scientific title
A Phase 1 Trial in Healthy Participants to Evaluate the Pharmacokinetics, Safety, Tolerability and Food Effects of Multiple Formulations of PRAX-114
Secondary ID [1] 300163 0
PRAX-114-102
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 315710 0
Condition category
Condition code
Mental Health 313995 313995 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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
Intervention code [1] 316440 0
Treatment: Drugs
Comparator / control treatment
Placebo tablets (same as PRAX-114 without the active ingredient) in Part C only
Control group
Placebo

Outcomes
Primary outcome [1] 322402 0
Pharmacokinetics will be performed by LC/MS quantification of PRAX-114 levels in plasma. Parameters include plasma concentrations and accumulation ratios.
Timepoint [1] 322402 0
Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48 and 72 hours post-dose for each dose administered
Secondary outcome [1] 378369 0
Safety and tolerability of PRAX-114 will be assessed through an integrated analysis of the following endpoints: patient and clinician-reported adverse events, physical exams, vital signs, clinical laboratory results, electrocardiogram (ECG), Columbia-Suicide Severity Rating Scale (C-SSRS), and Modified Observer's Assessment of Alertness/Sedation Scale (MOAA/S)
Timepoint [1] 378369 0
Part A: Baseline, Day 1 to Day 20, Day 26
Part B: Baseline, Day 1 to Day 20, Day 27
Part C: Baseline, Day 1 to Day 36, Day 40, Day 43, Day 47
Part D: Baseline, Day 1 to Day 17, Day 21, Day 24, Day 28

Eligibility
Key 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).
Minimum age
18 Years
Maximum age
55 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 1
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 304603 0
Commercial sector/Industry
Name [1] 304603 0
Praxis Precision Medicines Australia, Pty Ltd
Address [1] 304603 0
One Broadway, 16th Floor
Cambridge, MA 02142
Country [1] 304603 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Praxis Precision Medicines Australia, Pty Ltd
Address
Tower Two Collins Square, Level 36
727 Collins Street Docklands Vic 3008
Country
Australia
Secondary sponsor category [1] 304894 0
None
Name [1] 304894 0
Address [1] 304894 0
Country [1] 304894 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305023 0
Bellberry Human Research Ethics Committees
Ethics committee address [1] 305023 0
123 Glen Osmond Rd
Eastwood SA 5063
Ethics committee country [1] 305023 0
Australia
Date submitted for ethics approval [1] 305023 0
Approval date [1] 305023 0
08/10/2019
Ethics approval number [1] 305023 0

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 99006 0
Dr Tom Polasek
Address 99006 0
CMAX Clinical Research Pty Ltd
Level 5, 18a North Terrace,
Adelaide 5000, SA
Country 99006 0
Australia
Phone 99006 0
+61 0870887900
Fax 99006 0
Email 99006 0
Tom.polasek@cetara.com
Contact person for public queries
Name 99007 0
Dr Bernard Ravina
Address 99007 0
Praxis Precision Medicines
One Broadway, 16th Floor
Cambridge, MA 02142
Country 99007 0
United States of America
Phone 99007 0
+1 617 300 8460
Fax 99007 0
Email 99007 0
clinicaltrials@praxismedicines.com
Contact person for scientific queries
Name 99008 0
Dr Bernard Ravina
Address 99008 0
Praxis Precision Medicines
One Broadway, 16th Floor
Cambridge, MA 02142
Country 99008 0
United States of America
Phone 99008 0
+1 617 300 8460
Fax 99008 0
Email 99008 0
clinicaltrials@praxismedicines.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Individual participant data will not be shared
What supporting documents are/will be available?
No other documents available
Summary results
No Results