NCT06854783

Safety and Pharmacokinetics of Cannabidiol in Healthy Volunteers

A Phase 1, Open-Label, Multiple Dose Study to Assess the Pharmacokinetics, Safety, Tolerability, and Food Effect of MRX1 in Healthy Adults

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Tiamat Australia Pty Ltd · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to assess the pharmacokinetics, safety, tolerability and food effect of investigational drug MRX1 in healthy adults.

Detailed description

MRX1 is an oral solution containing cannabidiol. The primary objective of this study is the assess the pharmacokinetic profile of MRX1 at two doses when administered twice daily in healthy adults. The secondary objectives are to assess the safety and tolerability of MRX1 and to characterise the effect of a high fat, high calorie meal on the pharmacokinetics of a single dose of MRX1. A total of 20 healthy volunteers (10 male and 10 female) will be sequentially enrolled into 2 treatment groups, with 5 males and 5 females in each group. The duration of the study is up to 52 days per participant for Group A and 37 days per participant for Group B, including screening and follow up.

Conditions

• Pharmacokinetics

Interventions

Type	Name	Description
DRUG	Cannabidiol	Cannabidiol

Timeline

• Start date: 2025-07-14
• Primary completion: 2025-10-01
• Completion: 2025-10-01
• First posted: 2025-03-03
• Last updated: 2026-02-04

Locations

1 site across 1 country: Australia