Register a trial

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06303648




Registration number
NCT06303648
Ethics application status
Date submitted
20/02/2024
Date registered
12/03/2024

Titles & IDs
Public title
A Single, Ascending Dose Evaluation of the Safety, Pharmacokinetics of Methylone in Healthy Subjects
Scientific title
A Single, Ascending Dose Evaluation of the Safety, Pharmacokinetics of Methylone in Healthy Subjects
Secondary ID [1] 0 0
TSND201-PK-101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Post Traumatic Stress Disorder 0 0
Condition category
Condition code
Mental Health 0 0 0 0
Anxiety
Mental Health 0 0 0 0
Other mental health disorders
Mental Health 0 0 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Methylone

Experimental: Cohort 1 - 50 mg x 1 dose

Experimental: Cohort 2 - 100 mg x 1 dose

Experimental: Cohort 3 - 150 mg x 1 dose

Experimental: Cohort 4 - 200 mg x 1 dose


Treatment: Drugs: Methylone
Oral dose of methylone
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Cmax: Maximum Observed Plasma Concentration for methylone
Timepoint [1] 0 0
48 hours following the dose
Primary outcome [2] 0 0
AUC: Area under the plasma concentration-time curve for methylone
Timepoint [2] 0 0
48 hours following the dose
Secondary outcome [1] 0 0
Incidence and frequency of adverse events
Timepoint [1] 0 0
10 days after the dose
Secondary outcome [2] 0 0
Change overtime in Visual Analog Scales
Timepoint [2] 0 0
12 hours after the dose

Eligibility
Key inclusion criteria
Key

* Healthy adult male or female aged 25 to 55 inclusive
* Normal resting ECG
* Normal hematologic and hepatic function
* Normal renal function

Key
Minimum age
25 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* Vital sign abnormalities
* Positive urine drug screen at screening and / or Day -1
* Current mental illness such as depression, anxiety disorder, schizophrenia or other psychotic disorders

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
20/03/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
11/05/2024
Actual
Sample size
Target
24
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
CMAX Clinical Research - Adelaide
Recruitment postcode(s) [1] 0 0
5000 - Adelaide

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Transcend Therapeutics
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Ashley Lauritsch
Address 0 0
Country 0 0
Phone 0 0
+1 (952) 250-7788
Fax 0 0
Email 0 0
ashley@transcendtherapeutics.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06303648