Healthy volunteers Not Applicable
Conditions
Interventions
The study will consist of up to 32 participants split into 4 planned cohorts: each cohort investigating a different dose strength of OCT461201 starting at the lowest dose and gradually increasing in e
Sponsors
Oxford Cannabinoids Technologies Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Healthy male and female participants, between 18 and 55 years of age, inclusive, at the time of screening 2. Participant with a body mass index (BMI) of 18-30 kg/m2
Exclusion criteria
Exclusion criteria: 1. History of clinically significant neurological illnesses, head traumas or metabolic disorders. 2. Reports having experienced suicidal ideation (Type 4 or 5 on the Columbia-Suicide Severity Rating Scale [C-SSRS]) within 35 days prior to Screening, any suicidal behaviour within 2 years prior to Screening (Any “Yes” answers on the Suicidal Behaviour section of C-SSRS), and/or the Investigator assesses the participant to be a safety risk to him/herself or others; in the last 2 years. 3. Participation in a New Chemical Entity (NCE) clinical study within the previous 3 months or five half-lives, whichever is longer, or a marketed drug clinical study within 30 days or five half-lives, whichever is longer, or exposure to more than four new chemical entities within 12 months before the first dose of IMP. (The washout period between studies is defined as the period of time elapsed between the last dose of the previous study and the first dose of the next study).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoints for this study are safety endpoints and are defined as follows: 1. Adverse events (AEs) will be recorded from the point of informed consent up to the final post-study follow-up visit 2. Laboratory safety (biochemistry, haematology and urinalysis) at Screening, Day -1, Day 2, and post-study follow-up visit on Days 5-9 3. Vital signs (systolic/diastolic blood pressure, heart rate, respiratory rate, oral body temperature) at Screening, Day -1, Day 1 (pre-dose, 1 h, 2 h, 4 h, 8 h, 12 h post-dose), Day 2 (24 h post-dose) and post-study follow-up visit on Day 5-9 4. 12-lead ECG (heart rate, PR interval, QRS duration, QT interval and QTcF interval) at Screening, Day -1, Day 1 (pre-dose, 1 h, 2 h, 4 h, 8 h, 12 h post-dose), Day 2 (24 h post-dose) and post-study follow-up visit on Day 5-9 | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary endpoints for this study are PK parameters derived from the analysis of plasma and urine samples for concentrations of OCT461201. PK endpoints are defined as follows: Plasma: 1. Cmax - Maximum concentration. 2. Tmax - The time to maximum observed concentration 3. ?z - Elimination rate constant 4. t1/2 - Terminal elimination half-life 5. AUClast - Area under the concentration-time curve (AUC) from the time of dosing to the time of the last measurable concentration 6. AUC0-t - AUC from the time of dosing to the last time of the measurable concentration 7. AUC0-inf - AUC extrapolated to infinity 8. AUC% extrapolated - Residual area 9. CL/F - Apparent total body clearance following extravascular administration 10. Vz/F - Apparent volume of distribution following extravascular administration Measured using blood samples taken on Day 1: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24 and 48 hours post-dose For urine: 1. Ae - Amount and cumulative amount of dose excreted in urine over each collection interval 2. Ae% - % and cumulative % of dose excreted in urine over each collection interval 3. CLR - Renal clearance Measured using urine samples taken on Day 1: Pre-dose, 0-12 hours post-dose and 12-24 hours post-dose | — |
Countries
United Kingdom, Wales
Contacts
Public ContactValentino Parravicini
Outcome results
None listed