PK Study of Safety, Tolerability of COMP360 in Healthy Volunteers
Research type
Research Study
Full title
A Pharmacokinetic Study with an Integrated Food Effect Arm to Assess the Safety, Tolerability and QTcF Interval Following Different Strengths of COMP360 in Healthy Volunteers
IRAS ID
293827
Contact name
Pui Man Leung
Contact email
Sponsor organisation
Compass Pathfinder Limited
Eudract number
2021-000011-23
Duration of Study in the UK
0 years, 4 months, 26 days
Research summary
The purpose of this study is to test a drug called COMP360 (the ‘study drug’) that is being developed as a potential therapeutic treatment of depression.
Depression is a mood disorder that causes a persistent feeling of sadness and loss of interest, and the disease can lead to a variety of emotional and physical illnesses. If left untreated, depression may result in poor quality of life and even premature death from medical conditions or suicide. Many patients do not respond appropriately or suffer side-effects from drugs prescribed to treat depression, which results in patients not taking them.COMP360 is a synthetic (man-made) form of the psychedelic drug psilocybin. Psilocybin is a controlled drug and a chemical compound found in some species of mushrooms. Recent studies have suggested that psilocybin may help in treating depression. Psilocybin works on the serotonin system in the brain which is linked to the regulation of mood.
The study will be divided into two components, a pharmacokinetic component and a food effect component. The pharmacokinetic (PK) component will look at the safety and tolerability of increasing doses of the study drug on the body. It is planned to enrol up to 32 participants into 4 cohorts, comprising of 8 participants each, in the single dose PK component of the study. Each cohort will receive a single dose of either COMP360 or placebo under fasting conditions. The food effect component will examine if there are any differences in how the body absorbs the study drug when given on an empty stomach or when given shortly after a high fat breakfast. For the food effect component of this study, 12 participants will take part in two treatment periods.
The study will be run in a Phase I unit in the UK and will commence recruitment in May 2021.
REC name
Wales REC 1
REC reference
21/WA/0044
Date of REC Opinion
17 Mar 2021
REC opinion
Further Information Favourable Opinion