Relative Bioavailability Study of COMP360 in Healthy Volunteers (QSC207869)
Research type
Research Study
Full title
A phase I, open-label, randomised-sequence, two-way crossover study to assess the relative oral bioavailability of 25 mg and 5 mg strength capsules of COMP360 in healthy volunteers
IRAS ID
1005916
Contact name
Guy Goodwin
Contact email
Sponsor organisation
COMPASS Pathfinder Limited
ISRCTN Number
ISRCTN16636661
Research summary
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, low energy and concentration. Patients with treatment-resistant depression see no improvement of their symptoms with standard depression medication.
This two period healthy volunteer study will try to identify how the test medicine is taken up by the body when given at the same dose in different strengths, as well as the safety and tolerability of the test medicine.
This study will take place at one non-NHS site, enrolling at least 14 male/female volunteers aged between 18 to 55 years.
Volunteers will receive both of the following treatments, one at each of the study visits in a random order (either test then reference or reference then test): 25 mg COMP360 given as 1 x 25 mg capsule (test regimen) or 25 mg COMP360 given as 5 x 5 mg capsules (reference regimen).
In Treatment Period 1, at least 14 volunteers will receive an oral dose of COMP360 25 mg, either as a single capsule or as multiple capsules in a fed state. Volunteers will be discharged on Day 2 and have a washout period of 14 days before returning for the next study period.
In Treatment Period 2, at least 14 volunteers will receive an oral dose of COMP360 25 mg, either as a single capsule or as multiple capsules in a fed state. Volunteers will be discharged on Day 2 and will receive a follow-up call 5-11 days post final dose.
Volunteer’s blood and urine will be taken throughout the study for analysis of the test medicine and for their safety.
Volunteers are expected to be involved in this study for up to 8 weeks from screening to the follow-up call.
REC name
North East - York Research Ethics Committee
REC reference
22/NE/0106
Date of REC Opinion
2 Aug 2022
REC opinion
Further Information Favourable Opinion