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

Phase 1CompletedNCT06303648

Transcend Therapeutics40 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Post Traumatic Stress Disorder

Interventions

MethyloneDRUG

Oral dose of methylone

PlaceboDRUG

Placebo to match methylone

Eligibility

Sex: ALLMin age: 25 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

CMAX Clinical Research

Adelaide, South Australia, Australia

Outcomes

Primary Outcomes

Cmax: Maximum Observed Plasma Concentration for methylone

Time frame: 48 hours following the dose

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

Time frame: 48 hours following the dose

Secondary Outcomes

Incidence and frequency of adverse events

Time frame: 10 days after the dose

Data from ClinicalTrials.gov

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