A study in healthy volunteers to look at how COMP360 is taken up by the body when given as two different strength capsules

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.

Status Recruiting
Results Published No
Start date 16 June 2022
End date 04 January 2022
Chance of happening 100%
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.

NCT Number

Sponsors & Collaborators

COMPASS Pathways
COMPASS 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.

Data attribution

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