This open-label trial will assess the bioavailability of COMP360 (psilocybin) in healthy volunteers (n=14). The trial will assess the effects of both 5 and 25 mg doses of COMP360.
The overall aim of the trial is to explore how different doses of COMP360 are taken up by the body, further establish pharmacokinetic profiles and compare the safe and tolerability of single doses of 5 and 25 mg COMP360.
This trial is sponsored by COMPASS Pathways.
Topic Neuroscience
Compound Psilocybin
Country United Kingdom
Visit trial
Status
Recruiting
Results Published
No
Start date
16 June 2022
End date
04 January 2022
Phase
Phase I
Design
Open
Type
Interventional
Generation
Second
Participants
14
Sex
All
Age
18- 55
Therapy
No
Trial Details
The Sponsor is developing the test medicine, COMP360, for the potential treatment of treatment-resistant depression. Depression is a common mental health problem that can cause people to experience low mood, loss of motivation or pleasure, feelings of guilt or low self-worth, disturbed sleep, changes in appetite, and low energy, and concentration. Patients with treatment-resistant depression see no improvement in their symptoms with standard depression medication.Trial Number
Sponsors & Collaborators
COMPASS PathwaysCOMPASS Pathways is a publicly listed company (NASDAQ) that is developing psilocybin for treatment-resistant depression (TRD) for which it has completed a successful Phase IIb trial. COMPASS is one of the largest psychedelic companies and has received substantial investment from atai.