Clinical-stage pharmaceutical company Incannex Healthcare (ASX: IHL) has received approval from Bellberry Human Research Ethics Committee to commence a bioavailability/bioequivalence (BA/BE) clinical trial to assess the pharmacokinetics and tolerability of lead candidate IHL-42X in the treatment of obstructive sleep apnoea (OSA).
The trial will be managed by clinical contract research organisation Novotech and conducted at CMAX Clinical Research in South Australia.
It is designed to assess active pharmaceutical ingredients (APIs) dronabinol (tetrahydrocannabinol, or THC) and acetazolamide compared to their respective US Food and Drug Administration reference listed drugs.
It will also test the effect of food on the pharmacokinetics of the two APIs.
Over the course of the trial, 116 participants will each complete four single dose treatments of IHL-42X, dronabinol and acetazolamide under fasted conditions, plus IHL-42X under fed conditions.
Blood samples will be collected from all participants over 48 hours and the concentrations of APIs and major metabolites in the samples will be analysed.
Trial design
Incannex said the trial’s design is consistent with FDA recommendations and specific advice received from the pre-investigational new drug (IND) process regarding the drug’s development.
Results of the trial are expected to form a critical component of a future new drug application, providing the necessary bridge to the reference listed drugs and facilitating the use of historic safety data.
The company said the trial would run in parallel to a pivotal Phase 2/3 study due to commence after it opens an IND submission with the FDA.
Moving forward
Incannex chief scientific officer Dr Mark was pleased to be moving forward with the trial.
“Approval of this study by Bellberry allows us to move towards patient recruitment and data collection with CMAX and Novotech,” he said.
“We expect that being able to bridge to historic safety data on the reference listed drugs for dronabinol and acetazolamide will accelerate the development of this drug and reduce our cost and timelines.”
Obstructive sleep apnoea
Obstructive sleep apnoea is one of the world’s most common sleep-related breathing disorders.
It involves a narrowing of the upper airway during sleep which then interferes with a person’s breathing, decreasing their oxygen uptake and resulting in poor-quality sleep.
Untreated OSA can lead to long-term adverse health outcomes including hypertension, cardiovascular disease, heart attack, cognitive impairments, anxiety and depression, irritability and daytime fatigue.
There are currently no drugs available to treat people with OSA.
