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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT06303648




Registration number
NCT06303648
Ethics application status
Date submitted
20/02/2024
Date registered
12/03/2024
Date last updated
16/04/2024

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
This is an open-label, single, ascending dose study evaluating the PK and safety of methylone
in healthy subjects.
Trial website
https://clinicaltrials.gov/ct2/show/NCT06303648
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT06303648