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NCT06303648 Clinical Trial

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

Post Traumatic Stress Disorder Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06303648
Other study ID # TSND201-PK-101
Secondary ID
Status Recruiting
Phase Phase 1
First received
Last updated
Start date March 20, 2024
Est. completion date May 11, 2024

Study information
Verified date April 2024
Source Transcend Therapeutics
Contact Ashley Lauritsch
Phone +1 (952) 250-7788
Email ashley@transcendtherapeutics.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Recruiting
Enrollment 24
Est. completion date May 11, 2024
Est. primary completion date May 4, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 25 Years to 55 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• Methylone
Oral dose of methylone

Locations
Country Name City State
Australia CMAX Clinical Research Adelaide South Australia

Sponsors (1)
Lead Sponsor Collaborator
Transcend Therapeutics

Country where clinical trial is conducted

Australia, 

Outcome
Type Measure Description Time frame Safety issue
Primary Cmax: Maximum Observed Plasma Concentration for methylone 48 hours following the dose
Primary AUC: Area under the plasma concentration-time curve for methylone 48 hours following the dose
Secondary Incidence and frequency of adverse events 10 days after the dose
Secondary Change overtime in Visual Analog Scales 12 hours after the dose
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