Summary: Incannex Healthcare has completed dosing in a clinical trial evaluating the bioavailability and bioequivalence of IHL-42X, a combination drug candidate for treating obstructive sleep apnea. The trial compared the bioavailability of IHL-42X’s components, dronabinol and acetazolamide, to FDA reference drugs and assessed the impact of food on drug absorption. No serious adverse events were reported among the 115 participants.
Key Takeaways:
- Completion of Dosing: Incannex completed dosing for 115 participants in a trial assessing the bioavailability and bioequivalence of IHL-42X.
- Comparison and Analysis: The trial compared IHL-42X to FDA reference drugs Marinol and Taro acetazolamide, examining the pharmacokinetics under both fed and fasted conditions.
- Safety and Future Development: No serious adverse events were reported, and the data will aid future regulatory submissions by leveraging safety and toxicology data from reference drugs.
Incannex Healthcare announced the completion of participant dosing in a clinical trial assessing the bioavailability and bioequivalence of IHL-42X, a drug candidate aimed at treating obstructive sleep apnea.
IHL-42X comprises two drugs, dronabinol (synthetic delta-9-tetrahydrocannabinol [THC]), and acetazolamide. The bioavailability/bioequivalence (BA/BE) clinical trial was designed to compare the bioavailability of dronabinol and acetazolamide in IHL-42X as a fixed dose combination drug to the FDA reference listed drugs Marinol and Taro acetazolamide administered in isolation.
Study Design and Methodology
The BA/BE study also assessed the effect of food on the bioavailability of the drug substances in IHL-42X. All participants in the study completed four treatment periods, each consisting of a single dose each of IHL-42X, Marinol or acetazolamide under fasted conditions, or IHL-42X under fed conditions.
Blood samples were then collected at predefined intervals and analyzed for levels of acetazolamide, THC, and major THC metabolites. Participants were also monitored for adverse events throughout the study. 115 participants completed all four treatment periods, and no serious adverse events were reported during the study.
Data collected during the study will be processed and analyzed over the coming months. This will generate information on the pharmacokinetics of each of the active pharmaceutical ingredients in IHL-42X compared to the relevant reference-listed drugs.
Future Implications
These comparative pharmacokinetic profiles will facilitate the Company’s ability to rely on safety and toxicology data for the reference listed drugs in future regulatory submissions. The adverse event data from the BA/BE study will also contribute to the safety profile of IHL-42X as a combination product.
“Completion of dosing in the BA/BE study is an important milestone in the IHL-42X research program. The pharmacokinetics of cannabinoids are highly variable, so having data across the four treatment periods from this many subjects will provide incredibly valuable data for Incannex in the continued development of IHL-42X,” says Incannex chief scientific officer Mark Bleackley, PhD, says in a release. “The ability to rely on safety and toxicology data for the reference-listed drugs reduces the burden on Incannex and allows us to focus on safety and efficacy of the drug product in OSA patients.”
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