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Clinical trial

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

ID
Name
TSND201-PK-101
Description
This is an open-label, single, ascending dose study evaluating the PK and safety of methylone in healthy subjects.
Trial arms
Trial start
2024-03-20
Estimated PCD
2024-05-04
Trial end
2024-05-11
Status
Recruiting
Phase
Early phase I
Treatment
Methylone
Oral dose of methylone
Arms:
Cohort 1, Cohort 2, Cohort 3, Cohort 4
Size
24
Primary endpoint
Cmax: Maximum Observed Plasma Concentration for methylone
48 hours following the dose
AUC: Area under the plasma concentration-time curve for methylone
48 hours following the dose
Eligibility criteria
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'Subjects will be enrolled into one of four cohorts. The study will begin enrolling Cohort 1.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 24, 'type': 'ESTIMATED'}}
Updated at
2024-04-16

1 organization

1 product

1 indication

Organization
Transcend Therapeutics
Product
Methylone
Indication
Post-Traumatic Stress Disorder