A study to investigate the safety & PK of OCT461201 in healthy volunteers
Research type
Research Study
Full title
A Phase I, First-in-Human, Randomised, Double-Blind, Placebo-Controlled, Single Ascending Oral Dose, Safety, Tolerability and Pharmacokinetic Study to investigate the effects of OCT461201 in Healthy Volunteers
IRAS ID
1006789
Contact name
Gabrielle Brill
Contact email
Sponsor organisation
Oxford Cannabinoid Technologies Ltd.
Eudract number
2022-003422-41
ISRCTN Number
ISRCTN39003837
Research summary
Summary of Research\nThe purpose of this study is to investigate the study drug OCT461201. The main objectives of the study are:\n\n- To determine the safety and tolerability (degree to which side effects of a drug can be tolerated) of OCT461201 when it is administered once (in the form of oral capsules) at different dose strengths.\n\n- To investigate the concentration of OCT461201 in the blood and urine, how this changes over a period of time and to evaluate whether there are differences in the concentrations when different dose strengths are given. The study will consist of 4 planned groups of up to 8 participants (with the option to include a maximum of 4 additional groups with up to 8 participants per group): each group will evaluate a different dose of OCT461201 starting at the lowest dose and gradually increasing in each group. In this study, participants will either be given OCT461201 or a placebo (which contains no active drug). Both OCT461201 and the placebo will be administered in the form of an oral capsule (or multiple capsules dependent on dose strength) which participants will swallow with water. Blood and urine samples will be taken at set time points throughout the study in order to measure the concentration of OCT461201 in the blood and urine. We will compare the results from each of the dose groups to determine if there are any significant differences in the safety profile of OCT461201 and the concentration of OCT461201 in the blood and urine. The study will consist of a screening visit (between 35 and 2 days prior to the dose of OCT461201 on Day 1), 1 treatment period (consisting of 3 days with 2 overnight stays) , a return visit on Day 3 and a post-study follow-up visit 4-8 days following the dose of OCT461201 (Days 5-9).\n\nSummary of Results \nThe purpose of this study was to investigate the study drug OCT461201. The main objectives of the study were as follows:\n\nTo determine the safety and tolerability (degree to which side effects of a drug can be tolerated) of OCT461201 when it was administered once (in the form of oral capsules) at different dose strengths.\n\nTo investigate the concentration of OCT461201 in the blood and urine, how this changed over a period of time and to evaluate whether there were differences in the concentrations when different dose strengths were given.\n\nThe study consisted of 4 planned groups of up to 8 participants and included a screening visit (between 35 and 2 days prior to dose), one treatment period (consisting of 3 days with 2 overnight stays), a single return visit on Day 3 and a post-study follow-up visit 4-8 days after the dose of OCT461201 on Day 1. Blood and urine samples were taken at set time points throughout the study in order to measure the concentration of OCT461201 in the blood and urine. The results from each of the dose groups have been compared to determine if there were any significant differences in the safety profile of OCT461201 and the concentration of OCT461201 in the blood and urine. The below section outlines the key outcomes based on the study data generated.\n\nWith respect to the safety objectives of the study, it was determined that OCT461201 was considered to be safe and well tolerated across all dose strengths evaluated during the study (single doses of 10 mg, 50 mg, 150 mg & 450 mg. As it relates to side effects reported across the study, all of the reported side effects were considered to be mild in severity (with the exception of one moderate event) and resolved fully prior to completion of the study Further to this, all reported events were considered as not related to the study drug and resolved without treatment.\n\nAs it relates to the other objectives of the study, the following outcomes were reported:\n\nThe maximum concentration of OCT461201 in the blood was reached within 1 hour of administration, and the maximum levels in the blood increased as the dose strengths increased.\n\nThe time taken for the levels of the drug in the blood to half in value varied across the different dose strengths administered (ranging between 6 h – 17 h).\n\nThe levels of the study drug measured in the urine were low, suggesting that the study drug may be eliminated from the body via other routes.\n\nIn summary, the data gathered during the study was considered sufficient to meet the objectives of the study and warrant further studies and investigations of OCT461201.\n
REC name
Wales REC 2
REC reference
23/WA/0001
Date of REC Opinion
29 Mar 2023
REC opinion
Further Information Favourable Opinion