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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: OCT461201 100 mg; Drug: OCT461201 150 mg; Drug: OCT461201 450 mg; Drug: OCT461201 50 mg; Drug: Placebo

• Registration Number: NCT06398925
• Lead Sponsor: Oxford Cannabinoid Technologies Holdings PLC

Brief Summary

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.

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 Timeline

• Study Start: 2023-07-26
• Primary Completion: 2023-09-25
• Study Completion: 2023-09-25
• Status Verified: 2024-04
• Study First Submitted: 2024-04-23
• Study First Submitted QC: 2024-04-30
• Last Update Submitted: 2024-04-30
• Study First Posted: 2024-05-03
• Last Update Posted: 2024-05-03

Recruitment & Eligibility

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

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
OCT461201 Dose Level 4	Placebo	Single ascending dose of OCT461201 450 mg
Placebo	Placebo	Single dose of matching placebo
OCT461201 Dose Level 1	Placebo	Single ascending dose of OCT461201 10 mg
OCT461201 Dose Level 2	OCT461201 100 mg	Single ascending dose of OCT461201 50 mg
OCT461201 Dose Level 2	Placebo	Single ascending dose of OCT461201 50 mg
OCT461201 Dose Level 3	OCT461201 150 mg	Single ascending dose of OCT461201 150 mg
OCT461201 Dose Level 3	Placebo	Single ascending dose of OCT461201 150 mg
OCT461201 Dose Level 4	OCT461201 450 mg	Single ascending dose of OCT461201 450 mg
OCT461201 Dose Level 1	OCT461201 50 mg	Single ascending dose of OCT461201 10 mg

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetic parameter: t1/2	Day 1-3	Terminal elimination half life
Pharmacokinetic parameter: Cmax	Day 1-3	Maximum observed concentration
Pharmacokinetic parameter: AUC	Day 1-3	Overall exposure

Trial Locations

Locations (1)

Simbec-Orion; 🇬🇧 Merthyr Tydfil, United Kingdom