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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 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.

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06398925
Study type Interventional
Source Oxford Cannabinoid Technologies Holdings PLC
Contact
Status Completed
Phase Phase 1
Start date July 26, 2023
Completion date September 25, 2023
View Details
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