Trial Review

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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
6/05/2021
Date data sharing statement initially provided
28/04/2020
Date results information initially provided
6/05/2021
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
Sex
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
Completed
Date of first participant enrolment
Anticipated
Actual
5/02/2020
Date of last participant enrolment
Anticipated
Actual
8/07/2020
Date of last data collection
Anticipated
Actual
4/08/2020
Sample size
Target
100
Accrual to date
Final
85
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
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
[email protected]
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
[email protected]
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
[email protected]

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 Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.