A Single, Ascending Dose Evaluation of the Safety, Pharmacokinetics of Methylone in Healthy Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06303648

Enrollment

Registered

2024-03-12

Start date

2024-03-20

Completion date

2025-07-13

Last updated

2025-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post Traumatic Stress Disorder

Brief summary

This is an open-label, single, ascending dose study evaluating the PK and safety of methylone in healthy subjects.

Interventions

DRUGMethylone

Oral dose of methylone

DRUGPlacebo

Placebo to match methylone

Study design

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

Subjects will be enrolled into one of four cohorts. The study will begin enrolling Cohort 1.

Eligibility

Sex/Gender

ALL

Age

25 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Cmax: Maximum Observed Plasma Concentration for methylone	48 hours following the dose
AUC: Area under the plasma concentration-time curve for methylone	48 hours following the dose

Secondary

Measure	Time frame
Incidence and frequency of adverse events	10 days after the dose

Countries

Australia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026