This Phase I trial (n=44) aims to assess the safety, tolerability, and pharmacokinetics (how the drug is absorbed, distributed, and eliminated by the body) of COMP360 (psilocybin) in healthy volunteers. The study also investigates how food intake affects the body’s response to a 25 mg dose and examines the relationship between COMP360 dosage and heart function, specifically the QT interval (a measure of electrical activity in the heart).
The study consists of two parts. The first part is a single-dose, double-blind, placebo-controlled trial involving 32 participants who receive one of four doses of COMP360 (1 mg, 10 mg, 25 mg, or 50 mg) or a placebo under fasting conditions. The second part is an open-label, randomised crossover trial with 12 participants receiving a 25 mg dose of COMP360 twice—once after fasting and once after a high-fat meal—to evaluate the effects of food intake. Participants are closely monitored for 24 hours post-dose, with assessments of heart function, blood pressure, and overall well-being.
The study was conducted at MAC Clinical Research Centre (UK) and funded by Compass.
Trial Details
Background and study aims 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. Who can participate? People who join the study must be healthy men or women between 18 and 55 years old What does the study involve? The single dose part of the study involves giving either a single dose of the drug or a placebo (a harmless pill) to 32 healthy volunteers to find out what happens to the drug or placebo to your body after you take just one dose of it. They won't know if they're getting the real drug or the placebo, and they'll take it on an empty stomach. The food effect part of the study is an experiment where 12 participants will be randomly assigned to two different sequences of treatments where both the researchers and the participants know which treatment is being given. Each participant will take part in two treatment periods. They'll receive COMP360 (a specific dose of 25 mg) in both periods, once after not eating for a while and once after having a high-fat meal. Everyone will start with an overnight fast. Those in the fasting group will keep fasting, while those in the fed group will eat a meal 30 minutes before taking the dose. Before participants take the drug on the first day, measurements will be taken and then they'll take the drug. There will be a therapist there to help. Even if they're given a placebo, they'll still have support from the therapist. There will be monitoring of their heart, blood pressure, and blood samples taken through a needle. The session may be recorded on video for training purposes. They'll continue to be monitored for 24 hours after taking the drug, and any assessments will be recorded during this time. They'll also stay overnight at the site. The day after taking the drug, they'll undergo a safety check, talk about how they're feeling, and have assessments with the Study Clinician and therapist. After this, they'll be allowed to leave. Participants can contact the research team anytime if they have any problems or need help.Trial Number ISRCTN17905443
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.