A study carried out on healthy volunteers to understand how COMP360 can be taken in a safe and well-tolerated way

This interventional trial (n=44) studied the safety, tolerability, pharmacokinetics, and QT interval effects of different doses of COMP360 (psilocybin) in healthy volunteers, including an assessment of food effects.

The study consists of two parts:

  1. A single-dose pharmacokinetic (PK) component (n=32): This is a double-blind, placebo-controlled trial testing four doses of COMP360 (1 mg, 10 mg, 25 mg, 50 mg) or placebo in fasting conditions.
  2. A food effect (FE) component (n=12): This is an open-label, randomised crossover trial testing 25 mg of COMP360 in both fasting and fed conditions.

The study aims to investigate the safety and tolerability of COMP360, its pharmacokinetics at different doses and with/without food, and the relationship between drug concentration and QT interval changes.

Participants are healthy volunteers aged 18-55. The study involves dosing sessions with therapist support, overnight stays for monitoring, and various assessments including heart monitoring, blood sampling, and psychological evaluations.

The trial is being conducted at MAC Clinical Research Centre in the UK from November 2020 to October 2022, funded by COMPASS Pathfinder Limited. This Phase I study in healthy volunteers is an important step in developing COMP360 as a potential treatment for depression.

Topic Healthy Subjects
Compound Psilocybin
Country United Kingdom
Visit trial
Status Completed
Results Published No
Start date 01 November 2020
End date 31 October 2022
Phase Phase I
Design Open
Type Interventional
Generation Second
Participants 32
Sex All
Age 18- 55
Therapy No

Trial Details

COMP360 is being investigated as a drug for depression. This study aims to investigate how safe and well tolerated is the administration of four different doses of COMP360 in healthy volunteers. Also, it aims to investigate whether food intake or or different dosing have an impact on the way the body absorbs, distributes, and gets rid of COM360 as well as on how safe and well tolerated it is. Lastly, this study also wants to look into how the relationship between the concentration of the drug and a heart-related measurement called the QT interval changes as the dose of COMP360 changes.

NCT Number ISRCTN17905443

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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