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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06398925
• Other study ID #: OCT-001-2023
• Status: Completed
• Phase: Phase 1
• Start date: July 26, 2023
• Est. completion date: September 25, 2023

Study information

• Verified date: April 2024
• Source: Oxford Cannabinoid Technologies Holdings PLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: September 25, 2023
• Est. primary completion date: September 25, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• OCT461201 50 mg
Oral capsule
• OCT461201 100 mg
Oral capsule
• OCT461201 150 mg
Oral capsule
• OCT461201 450 mg
Oral capsule
• Placebo
Placebo capsule

Locations

Country	Name	City	State
United Kingdom	Simbec-Orion	Merthyr Tydfil

Sponsors (2)

Lead Sponsor	Collaborator
Oxford Cannabinoid Technologies Holdings PLC	Simbec-Orion Group

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with Treatment Emergent Adverse Events during the study assessed as mild, moderate or severe		Day 1-9
Secondary	Pharmacokinetic parameter: Cmax	Maximum observed concentration	Day 1-3
Secondary	Pharmacokinetic parameter: AUC	Overall exposure	Day 1-3
Secondary	Pharmacokinetic parameter: t1/2	Terminal elimination half life	Day 1-3