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

Transcend Therapeutics

Status and phase: Completed; Phase 1

Conditions: Post Traumatic Stress Disorder

Treatments: Drug: Placebo; Drug: Methylone

Study type: Interventional

Funder types: Industry

Identifiers

NCT06303648

TSND201-PK-101

Details and patient eligibility

About

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

Enrollment: 40 patients

Sex: All

Ages: 25 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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40 participants in 5 patient groups

Cohort 1

Experimental group

Description:

50 mg x 1 dose

Treatment:

Drug: Methylone

Cohort 2

Experimental group

Description:

100 mg x 1 dose

Treatment:

Drug: Methylone

Cohort 3

Experimental group

Description:

150 mg x 1 dose

Treatment:

Drug: Methylone

Cohort 4

Experimental group

Description:

200 mg x 1 dose

Treatment:

Drug: Methylone

Cohort 5

Experimental group

Description:

150 mg + 100 mg x 1

Treatment:

Drug: Methylone

Drug: Placebo