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

April 14, 2024 updated by: Transcend Therapeutics
This is an open-label, single, ascending dose study evaluating the PK and safety of methylone in healthy subjects.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

24

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Australia
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Recruiting
        • CMAX Clinical Research
        • Contact:
          • Research Team

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cohort 1
50 mg x 1 dose
Drug: Methylone
Oral dose of methylone
Experimental: Cohort 2
100 mg x 1 dose
Drug: Methylone
Oral dose of methylone
Experimental: Cohort 3
150 mg x 1 dose
Drug: Methylone
Oral dose of methylone
Experimental: Cohort 4
200 mg x 1 dose
Drug: Methylone
Oral dose of methylone

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence and frequency of adverse events
Time Frame: 10 days after the dose
10 days after the dose
Change overtime in Visual Analog Scales
Time Frame: 12 hours after the dose
12 hours after the dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Transcend Therapeutics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 20, 2024

Primary Completion (Estimated)

May 4, 2024

Study Completion (Estimated)

May 11, 2024

Study Registration Dates

First Submitted

February 20, 2024

First Submitted That Met QC Criteria

March 4, 2024

First Posted (Actual)

March 12, 2024

Study Record Updates

Last Update Posted (Actual)

April 16, 2024

Last Update Submitted That Met QC Criteria

April 14, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TSND201-PK-101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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