HealthyPhase 1NCT06398925
Single Ascending Oral Dose Study to Investigate the Effects of OCT461201 in Healthy Volunteers
A Phase 1 study testing OCT461201 50 mg, OCT461201 100 mg and OCT461201 150 mg in people with Healthy, run by Oxford Cannabinoid Technologies Holdings PLC at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- OCT461201 50 mg, OCT461201 100 mg and OCT461201 150 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 26 Jul 2023to 25 Sep 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Healthy
- Being tested
- OCT461201 50 mg, OCT461201 100 mg, OCT461201 150 mg, OCT461201 450 mg, Placebo
- Keywords
- Phase 1, Single Ascending Dose, Health volunteer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OCT461201 50 mgDrug
Oral capsule
OCT461201 100 mgDrug
Oral capsule
OCT461201 150 mgDrug
Oral capsule
OCT461201 450 mgDrug
Oral capsule
PlaceboDrug
Placebo capsule
| Study group | Role | What they receive |
|---|---|---|
| OCT461201 Dose Level 1 | Experimental | Single ascending dose of OCT461201 10 mg Receives: Drug: OCT461201 50 mg; Drug: Placebo |
| OCT461201 Dose Level 2 | Experimental | Single ascending dose of OCT461201 50 mg Receives: Drug: OCT461201 100 mg; Drug: Placebo |
| OCT461201 Dose Level 3 | Experimental | Single ascending dose of OCT461201 150 mg Receives: Drug: OCT461201 150 mg; Drug: Placebo |
| OCT461201 Dose Level 4 | Experimental | Single ascending dose of OCT461201 450 mg Receives: Drug: OCT461201 450 mg; Drug: Placebo |
| Placebo | Placebo comparator | Single dose of matching placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Treatment Emergent Adverse Events during the study assessed as mild, moderate or severe
Measured: Day 1-9
Secondary outcomes (3)
Pharmacokinetic parameter: Cmax
Maximum observed concentration
Measured: Day 1-3
Pharmacokinetic parameter: AUC
Overall exposure
Measured: Day 1-3
Pharmacokinetic parameter: t1/2
Terminal elimination half life
Measured: Day 1-3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2024
- Study start26 Jul 2023
- Primary completion25 Sep 2023
- Study completion25 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Single ascending dose
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oxford Cannabinoid Technologies Holdings PLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Simbec-Orion Group
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06398925
- Sponsor's protocol ID
- OCT-001-2023
- Status last verified
- Apr 2024
- First submitted
- 23 Apr 2024
- Last updated
- 3 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06398925
- Acronym / sponsor ID
- OCT-001-2023
- Conditions
- Healthy
- Keywords
- Phase 1, Single Ascending Dose, Health volunteer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Oxford Cannabinoid Technologies Holdings PLCIndustry (pharma, biotech, devices)
- Collaborators
- Simbec-Orion Group
- Study start
- 26 Jul 2023 (actual)
- Primary completion
- 25 Sep 2023 (actual)
- Study completion
- 25 Sep 2023 (actual)
- First posted
- 3 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
- Model description
- Single ascending dose
| Arm | Type | Receives |
|---|---|---|
| OCT461201 Dose Level 1 | Experimental | Drug: OCT461201 50 mg, Drug: PlaceboSingle ascending dose of OCT461201 10 mg |
| OCT461201 Dose Level 2 | Experimental | Drug: OCT461201 100 mg, Drug: PlaceboSingle ascending dose of OCT461201 50 mg |
| OCT461201 Dose Level 3 | Experimental | Drug: OCT461201 150 mg, Drug: PlaceboSingle ascending dose of OCT461201 150 mg |
| OCT461201 Dose Level 4 | Experimental | Drug: OCT461201 450 mg, Drug: PlaceboSingle ascending dose of OCT461201 450 mg |
| Placebo | Placebo comparator | Drug: PlaceboSingle dose of matching placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OCT461201 50 mgOral capsule | Drug | OCT461201 Dose Level 1 |
| OCT461201 100 mgOral capsule | Drug | OCT461201 Dose Level 2 |
| OCT461201 150 mgOral capsule | Drug | OCT461201 Dose Level 3 |
| OCT461201 450 mgOral capsule | Drug | OCT461201 Dose Level 4 |
| PlaceboPlacebo capsule | Drug | OCT461201 Dose Level 1, OCT461201 Dose Level 2, OCT461201 Dose Level 3, OCT461201 Dose Level 4, Placebo |
Primary outcome
Number of Participants with Treatment Emergent Adverse Events during the study assessed as mild, moderate or severe
Time frame: Day 1-9
3 secondary outcomes
Pharmacokinetic parameter: Cmax
Time frame: Day 1-3
Pharmacokinetic parameter: AUC
Time frame: Day 1-3
Pharmacokinetic parameter: t1/2
Time frame: Day 1-3
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing OCT461201 50 mg, OCT461201 100 mg and OCT461201 150 mg in people with Healthy, run by Oxford Cannabinoid Technologies Holdings PLC at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Treatment Emergent Adverse Events during the study assessed as mild, moderate or severe (time frame: Day 1-9). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2024.