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Incannex Receives Ethics Approval for Bioequivalence/Bioavailability Clinical Trial for IHL-42X, the Company’s Proprietary Drug for Treatment of Obstructive Sleep Apnoea (‘OSA’)
Highlights: Incannex has received approval from Bellberry Human Research Ethics Committee (‘HREC’) to commence the bioavailability/bioequivalence (‘BA/BE’)
About this update from Incannex Healthcare Inc.
[{"type":"text","content":"Highlights: Incannex has received approval from Bellberry Human Research Ethics Committee (‘HREC’) to commence the bioavailability/bioequivalence (‘BA/BE’) clinical trial to assess the pharmacokinetics and tolerability of IHL-42XThe trial will include 116 participants at CMAX Clinical Research in South Australia and will be managed by NovotechData from the clinical trial will be a critical component of future marketing submissions for IHL-42X for treatment of OSAThe trial will be conducted in parallel to the IND opening and pivotal Phase 2/3 clinical trialOSA is highly prevalent, affecting approximately 30 million adults in the United States alone and there are no registered prescription drugs available to patients for the treatment of OSAThe design of the BA/BE trial is consistent with FDA recommendations as part of the required research required to undertake a new drug application. MELBOURNE, Australia, July 06, 2023 (GLOBE NEWSWIRE) -- Incannex Healthcare Limited (Nasdaq: IXHL) (ASX: IHL), (‘Incannex’ or the ‘Company’) a clinical-stage pharmaceutical company developing unique medicinal cannabinoid pharmaceutical products and psychedelic medicine therapies for unmet medical needs, is pleased to announce that Incannex has received approval from Bellberry Human Research Ethics Committee to commence a bioavailability/bioequivalence (‘BA/BE’) clinical trial on IHL-42X, the Company’s proprietary drug product for treatment of obstructive sleep apnoea. The BA/BE clinical trial will assess the pharmacokinetics and tolerability of the two active pharmaceutical ingredients (‘APIs’) in IHL-42X, dronabinol (‘THC’) and acetazolamide, compared to the respective FDA reference listed drugs, as well as the effect of food on pharmacokinetics of the two APIs. The study will include 116 participants who will each complete four (4) 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 APIs 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 BA/BE trial is consistent with US Food and Drug Administration (‘FDA’) recommendations and specif...