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

Phase 1

Recruiting

• Conditions: Post Traumatic Stress Disorder
• Interventions: Drug: Methylone

• Registration Number: NCT06303648
• Lead Sponsor: Transcend Therapeutics

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-02-20
• Study First Submitted QC: 2024-03-04
• Study First Posted: 2024-03-12
• Study Start: 2024-03-20
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-14
• Last Update Posted: 2024-04-16
• Primary Completion: 2024-05-04
• Study Completion: 2024-05-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 24

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

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Cohort 2	Methylone	100 mg x 1 dose
Cohort 3	Methylone	150 mg x 1 dose
Cohort 1	Methylone	50 mg x 1 dose
Cohort 4	Methylone	200 mg x 1 dose

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Incidence and frequency of adverse events	10 days after the dose
Change overtime in Visual Analog Scales	12 hours after the dose

Trial Locations

Locations (1)

CMAX Clinical Research; 🇦🇺 Adelaide, South Australia, Australia