Incannex Healthcare Ltd, a clinical-stage pharmaceutical company developing medicinal cannabinoid pharmaceutical products and psychedelic medicine therapies, has received approval from Bellberry Human Research Ethics Committee to commence a bioavailability/bioequivalence clinical trial on IHL-42X, the company’s proprietary drug product for the treatment of obstructive sleep apnea.
The clinical trial will assess the pharmacokinetics and tolerability of the two active pharmaceutical ingredients in IHL-42X, dronabinol (THC) and acetazolamide, compared to the respective US Food and Drug Administration (FDA) reference listed drugs, as well as the effect of food on pharmacokinetics of the two active pharmaceutical ingredients.
The study will include 116 participants who will each complete four single-dose treatment periods, being dosed with IHL-42X, dronabinol and acetazolamide under fasted conditions, as well as IHL-42X under fed conditions. Blood samples will be collected over 48 hours, and the concentrations of the active pharmaceutical ingredients and their major metabolites in the samples will be analysed.
The clinical trial will be conducted at CMAX Clinical Research in Adelaide, South Australia, and managed by Novotech. The design of the trial is consistent with FDA recommendations and specific advice received by Incannex in its pre-Investigative New Drug (IND) application with the FDA regarding the development of IHL-42X for the treatment of OSA.
The results of the trial will form a critical component of a future new drug application, providing the necessary bridge to the reference listed drugs, thereby facilitating the use of historic safety data via the FDA505(b)2 regulatory pathway. Importantly, the study will run in parallel to the pivotal phase 2/3 trial that will commence after the company opens an IND with the FDA.
“The [bioavailability/bioequivalence] trial is a very important component of the IHL-42X pipeline. Being able to bridge to historic safety data on the reference listed drugs for dronabinol and acetazolamide accelerates the development of the drug product and reduces cost and timelines,” says Incannex chief scientific officer Mark Bleackley in a release. “Approval of the study by Bellberry HREC for the [bioavailability/bioequivalence] study allows us to move towards patient recruitment and data collection with CMAX and Novotech.”
