Ignite Creation Date:
2024-05-06 @ 8:28 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06398925
Status:
COMPLETED
Last Update Posted:
2024-05-03
First Post:
2024-04-23
Brief Title:
Single Ascending Oral Dose Study to Investigate the Effects of OCT461201 in Healthy Volunteers
Sponsor:
Oxford Cannabinoid Technologies Holdings PLC
Organization:
Oxford Cannabinoid Technologies Holdings PLC
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 ie 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 cohortdose level
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 ie 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 cohortdose level
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None