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

Oxford Cannabinoid Technologies Holdings PLC

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Placebo; Drug: OCT461201 450 mg; Drug: OCT461201 150 mg; Drug: OCT461201 50 mg; Drug: OCT461201 100 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT06398925

OCT-001-2023

Details and patient eligibility

About

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.

Full 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.

Enrollment: 32 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

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32 participants in 5 patient groups, including a placebo group

OCT461201 Dose Level 1

Experimental group

Description:

Single ascending dose of OCT461201 10 mg

Treatment:

Drug: OCT461201 50 mg

Drug: Placebo

OCT461201 Dose Level 2

Experimental group

Description:

Single ascending dose of OCT461201 50 mg

Treatment:

Drug: OCT461201 100 mg

Drug: Placebo

OCT461201 Dose Level 3

Experimental group

Description:

Single ascending dose of OCT461201 150 mg

Treatment:

Drug: OCT461201 150 mg

Drug: Placebo

OCT461201 Dose Level 4

Experimental group

Description:

Single ascending dose of OCT461201 450 mg

Treatment:

Drug: OCT461201 450 mg

Drug: Placebo

Placebo

Placebo Comparator group

Description:

Single dose of matching placebo

Treatment:

Drug: Placebo