Clinical trial NCT06398925: Single Ascending Oral Dose Study to Investigate the Effects of OCT461201 in Healthy Volunteers
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Phase 1
Single Ascending Dose
Health volunteer
Lead sponsor: Oxford Cannabinoid Technologies Holdings PLC
Sponsor class: INDUSTRY
Collaborators: name: Simbec-Orion Group
First posted: 2024-05-03
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Single ascending dose
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants with Treatment Emergent Adverse Events during the study assessed as mild, moderate or severe
timeFrame: Day 1-9
Secondary outcomes:
measure: Pharmacokinetic parameter: Cmax
timeFrame: Day 1-3
measure: Pharmacokinetic parameter: AUC
timeFrame: Day 1-3
measure: Pharmacokinetic parameter: t1/2
timeFrame: Day 1-3
Other outcomes:
Locations:
city: Merthyr Tydfil
country: United Kingdom
facility: Simbec-Orion
Study officials:
References: