A study to investigate the safety and concentration in the blood and urine of different dose strengths of OCT461201 in healthy volunteers

Phase 1

Completed

• Conditions: Healthy volunteers; Not Applicable

• Registration Number: ISRCTN39003837
• Lead Sponsor: Oxford Cannabinoids Technologies Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-05-31
• Study Completion: 2023-08-31
• Last Update Posted: 3 June 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 32

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

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).

Study & Design

• Study Type: Interventional
• Study Design: Not specified