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OpenTrials
Completed

NCT Number: NCT06303648

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

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

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Key information

Conditions

Post Traumatic Stress Disorder Mental Disorders Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

25 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

CMAX Clinical Research

Adelaide, South Australia, 5000, Australia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Methylone

Drug

Oral dose of methylone

Placebo

Drug

Placebo to match methylone

Primary outcomes

  1. Cmax: Maximum Observed Plasma Concentration for methylone

    Time frame: 48 hours following the dose

  2. AUC: Area under the plasma concentration-time curve for methylone

    Time frame: 48 hours following the dose

Secondary outcomes

  1. Incidence and frequency of adverse events

    Time frame: 10 days after the dose

Sponsors and collaborators

Lead sponsor

Transcend Therapeutics

Industry

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Mar 12, 2024
Registry last updated
Sep 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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