Evaluating the safety and pharmacokinetics of methylone in healthy adults
A Single, Ascending Dose Evaluation of the Safety, Pharmacokinetics of Methylone in Healthy Subjects
This study tests how safe methylone is and how the body processes it in healthy adults aged 25 to 55.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 25 Years to 55 Years |
| Sex | All |
| Sponsor | Transcend Therapeutics Industry-sponsored |
| Locations | 1 site (Adelaide, South Australia) |
| Trial ID | NCT06303648 on ClinicalTrials.gov |
What this trial studies
This study is an open-label, single ascending dose evaluation aimed at assessing the safety and pharmacokinetics of methylone in healthy subjects. Participants will receive varying doses of methylone to determine how the drug is processed in the body and to monitor any potential side effects. The study focuses on healthy adults aged 25 to 55, ensuring that participants have normal health parameters. The findings could provide insights into the drug's effects and safety profile for future applications.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy adults aged 25 to 55 with normal health parameters.
Not a fit: Patients with current mental illnesses or those with abnormal vital signs will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help establish a safe dosage and pharmacokinetic profile for methylone, potentially paving the way for its use in treating conditions like PTSD.
How similar studies have performed: While this approach is novel in evaluating methylone specifically, similar studies on other psychoactive substances have shown varying degrees of success.
Eligibility criteria
Show full inclusion / 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
Where this trial is running
Adelaide, South Australia
- CMAX Clinical Research — Adelaide, South Australia, Australia (Recruiting)
Study contacts
- Study coordinator: Ashley Lauritsch
- Email: ashley@transcendtherapeutics.com
- Phone: +1 (952) 250-7788
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.