Single Ascending Oral Dose Study to Investigate the Effects of OCT461201 in Healthy Volunteers
April 30, 2024 updated by: Oxford Cannabinoid Technologies Holdings PLC
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
Intervention / Treatment
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
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Merthyr Tydfil, United Kingdom, CF48 4DR
- Simbec-Orion
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Sequential Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: OCT461201 Dose Level 1
Single ascending dose of OCT461201 10 mg
|
Placebo capsule
Oral capsule
|
|
Experimental: OCT461201 Dose Level 2
Single ascending dose of OCT461201 50 mg
|
Placebo capsule
Oral capsule
|
|
Experimental: OCT461201 Dose Level 3
Single ascending dose of OCT461201 150 mg
|
Placebo capsule
Oral capsule
|
|
Experimental: OCT461201 Dose Level 4
Single ascending dose of OCT461201 450 mg
|
Placebo capsule
Oral capsule
|
|
Placebo Comparator: Placebo
Single dose of matching 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
Time Frame: Day 1-9
|
Day 1-9
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pharmacokinetic parameter: Cmax
Time Frame: Day 1-3
|
Maximum observed concentration
|
Day 1-3
|
|
Pharmacokinetic parameter: AUC
Time Frame: Day 1-3
|
Overall exposure
|
Day 1-3
|
|
Pharmacokinetic parameter: t1/2
Time Frame: Day 1-3
|
Terminal elimination half life
|
Day 1-3
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.