A Single, Ascending Dose Evaluation of the Safety, Pharmacokinetics of Methylone in Healthy Subjects
NCT ID: NCT06303648
Last Updated: 2025-09-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
40 participants
INTERVENTIONAL
2024-03-20
2025-07-13
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Cohort 1
50 mg x 1 dose
Methylone
Oral dose of methylone
Cohort 2
100 mg x 1 dose
Methylone
Oral dose of methylone
Cohort 3
150 mg x 1 dose
Methylone
Oral dose of methylone
Cohort 4
200 mg x 1 dose
Methylone
Oral dose of methylone
Cohort 5
150 mg + 100 mg x 1
Methylone
Oral dose of methylone
Placebo
Placebo to match methylone
Interventions
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Methylone
Oral dose of methylone
Placebo
Placebo to match methylone
Eligibility Criteria
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Inclusion Criteria
* Normal resting ECG
* Normal hematologic and hepatic function
* Normal renal function
Exclusion Criteria
* Positive urine drug screen at screening and / or Day -1
* Current mental illness such as depression, anxiety disorder, schizophrenia or other psychotic disorders
25 Years
55 Years
ALL
Yes
Sponsors
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Transcend Therapeutics
INDUSTRY
Responsible Party
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Locations
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CMAX Clinical Research
Adelaide, South Australia, Australia
Countries
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Other Identifiers
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TSND201-PK-101
Identifier Type: -
Identifier Source: org_study_id
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