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Dosing completed in 115 participant bioavailability/bioequivalence clinical trial for proprietary sleep apnea drug candidate IHL-42X
IHL-42X is a fixed dose combination drug targeting obstructive sleep apnea (OSA), a medical condition with no available registered pharmaceutical treatment
About this update from Incannex Healthcare Inc.
[{"type":"text","content":"IHL-42X is a fixed dose combination drug targeting obstructive sleep apnea (OSA), a medical condition with no available registered pharmaceutical treatment for millions of sufferers in the USA alone.bioavailability/bioequivalence (‘BA/BE’) clinical trial assessed the pharmacokinetics and tolerability of IHL-42X consistent with FDA development plan.Analysis of data underway, however, no serious adverse events were reported.Phase 2/3 FDA IND-enabling RePOSA clinical trial continues after dosing commenced in May 2024.\n NEW YORK and MELBOURNE, Australia, July 30, 2024 (GLOBE NEWSWIRE) -- Incannex Healthcare Inc. (Nasdaq: IXHL), (‘Incannex’ or the ‘Company’), a clinical-stage pharmaceutical company developing proprietary medicinal cannabinoid products and psychedelic-assisted psychotherapies, is pleased to announce that it has completed participant dosing in the IHL-42X Bioavailability/Bioequivalence (BA/BE) clinical trial.\n IHL-42X comprises two drugs, dronabinol (synthetic delta-9-tetrahydrocannabinol (THC)), and acetazolamide. The 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. 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 analysed 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.\n Data collected during the study will be processed and analysed 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. 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 ...