Single Ascending Oral Dose Study to Investigate the Effects of OCT461201 in Healthy Volunteers

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

A study in healthy volunteers to evaluate the safety, tolerability and pharmacokinetics of OCT461201. The study included a screening period, a single dose of study treatment or placebo and a follow up period.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Placebo; Drug: OCT461201 50 mg; Drug: OCT461201 100 mg; Drug: OCT461201 150 mg; Drug: OCT461201 450 mg

Detailed Description

A phase 1, randomised, double-blind, placebo-controlled study to evaluate the safety, tolerability, and pharmacokinetics of OCT461201 in healthy participants following ascending single doses.

The study comprised a screening period (Day -35 to Day -2), a treatment period (Day -1 to Day 3) and a post-study follow-up visit 4 - 8 days following administration of OCT461201 or placebo (i.e., Day 5 - 9). A dose leader design was implemented with 2 participants being dosed on the first dosing day (1 randomised to placebo, 1 to active drug) and the remainder of the cohort dosed at least 24 hours later pending an acceptable safety profile in the dose leader group. Safety and Pharmacokinetic data was reviewed by the Dose Escalation Review Committee before escalation to the next cohort/dose level.

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • Merthyr Tydfil, United Kingdom, CF48 4DR
    • Simbec-Orion

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Healthy male and female participant, between 15 and 55 years of age inclusive at screening
• Body mass index (BMI) of 18-30 kg/m2
• No clinically significant history of previous allergy/sensitivity to compounds similar to experimental drug or any of its excipients
• No clinically significant results for serum biochemistry, haematology and/or urine analysis within 35 days before first dose of Investigational Medicinal Product (IMP)
• No clinically significant abnormalities in 12-lead ECG within 35 days before dose of IMP
• Available to complete the study including all follow up visits

Exclusion Criteria:

• Clinically significant history of gastrointestinal disorder likely to influence IMP absorption
• Evidence of renal, hepatic, central nervous system, respiratory, cardiovascular or metabolic dysfunction
• Participation in a new chemical entity clinical study within the previous 3 months or 5 half-lives, whichever was longer

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Quadruple

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: OCT461201 Dose Level 1; Single ascending dose of OCT461201 10 mg	Drug: Placebo; Placebo capsule; Drug: OCT461201 50 mg; Oral capsule
Experimental: OCT461201 Dose Level 2; Single ascending dose of OCT461201 50 mg	Drug: Placebo; Placebo capsule; Drug: OCT461201 100 mg; Oral capsule
Experimental: OCT461201 Dose Level 3; Single ascending dose of OCT461201 150 mg	Drug: Placebo; Placebo capsule; Drug: OCT461201 150 mg; Oral capsule
Experimental: OCT461201 Dose Level 4; Single ascending dose of OCT461201 450 mg	Drug: Placebo; Placebo capsule; Drug: OCT461201 450 mg; Oral capsule
Placebo Comparator: Placebo; Single dose of matching placebo	Drug: Placebo; Placebo capsule

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of Participants with Treatment Emergent Adverse Events during the study assessed as mild, moderate or severe	Day 1-9

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetic parameter: Cmax	Maximum observed concentration	Day 1-3
Pharmacokinetic parameter: AUC	Overall exposure	Day 1-3
Pharmacokinetic parameter: t1/2	Terminal elimination half life	Day 1-3

Collaborators and Investigators

• Sponsor: Oxford Cannabinoid Technologies Holdings PLC
• Collaborators: Simbec-Orion Group

Study record dates

Study Major Dates

• Study Start (Actual): July 26, 2023
• Primary Completion (Actual): September 25, 2023
• Study Completion (Actual): September 25, 2023

Study Registration Dates

• First Submitted: April 23, 2024
• First Submitted That Met QC Criteria: April 30, 2024
• First Posted (Actual): May 3, 2024

Study Record Updates

• Last Update Posted (Actual): May 3, 2024
• Last Update Submitted That Met QC Criteria: April 30, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Phase 1; Single Ascending Dose; Health volunteer
• Other Study ID Numbers: OCT-001-2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No