NCT06303648

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Mar 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 20, 2024

Completed
21 days until next milestone

First Posted

Study publicly available on registry

March 12, 2024

Completed
8 days until next milestone

Study Start

First participant enrolled

March 20, 2024

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 13, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 13, 2025

Completed
Last Updated

September 9, 2025

Status Verified

September 1, 2025

Enrollment Period

1.3 years

First QC Date

February 20, 2024

Last Update Submit

September 2, 2025

Conditions

Post Traumatic Stress Disorder

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (1)

  • Incidence and frequency of adverse events

    10 days after the dose

Study Arms (5)

Cohort 1

EXPERIMENTAL

50 mg x 1 dose

Drug: Methylone

Cohort 2

EXPERIMENTAL

100 mg x 1 dose

Drug: Methylone

Cohort 3

EXPERIMENTAL

150 mg x 1 dose

Drug: Methylone

Cohort 4

EXPERIMENTAL

200 mg x 1 dose

Drug: Methylone

Cohort 5

EXPERIMENTAL

150 mg + 100 mg x 1

Drug: MethyloneDrug: Placebo

Interventions

MethyloneDRUG

Oral dose of methylone

Cohort 1Cohort 2Cohort 3Cohort 4Cohort 5
PlaceboDRUG

Placebo to match methylone

Cohort 5

Eligibility Criteria

Age25 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CMAX Clinical Research

Adelaide, South Australia, 5000, Australia

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

methylone

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Model Details: Subjects will be enrolled into one of four cohorts. The study will begin enrolling Cohort 1.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 20, 2024

First Posted

March 12, 2024

Study Start

March 20, 2024

Primary Completion

July 13, 2025

Study Completion

July 13, 2025

Last Updated

September 9, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

AU(1)