Module 5 Presentations

05/07/2024

France clinical trial - BIA 10-2474 (1)

• BIA 10-2474 is an experimental fatty acid amide hydrolase inhibitor developed by the Portuguese pharmaceutical company BIAL.

• It interacts with the human endocannabinoid system.

• The drug was in development for the treatment of a range of different medical conditions from anxiety disorder to Parkinson’s disease, also for the treatment of chronic pain of multiple sclerosis, cancer, or treatment of obesity. • The study was approved by the French regulatory authority on 26 June 2015, and by the Brest regional ethics committee on 3 July 2015.

Kerbrat; et al. (3 November 2016). "Acute Neurologic Disorder from an Inhibitor of Fatty Acid Amide Hydrolase". New England Journal of Medicine. 375 (18): 1717–1725. doi:10.1056/NEJMoa1604221. PMID 27806235.

The Organisation for Professionals in Regulatory Affairs

BIA 10-2474

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France clinical trial - BIA 10-2474 (2)

• “Phase I double-blind, randomised, placebo-controlled, combined single and multiple ascending dose study including food interaction, to investigate the safety, tolerability, pharmacokinetic and pharmacodynamic profile of BIA 10-2474, in healthy volunteers". • The trial commenced on 9 July 2015 at a single centre, and commenced recruitment of 128 healthy volunteers, both men and women aged 18 to 55, out of which 90 people were to receive the investigational drug, and the remainder a placebo. • Participants of the study were to receive €1,900 and, in turn, asked to stay at Biotrial's facility for two weeks during which time they would take the drug for ten days and undergo tests.

According to the protocol, dose levels and numbers of groups could be increased, or were not yet defined, and would depend on what was observed with initial dosing, (an approach known as adaptive trial design).

The Organisation for Professionals in Regulatory Affairs

BIA 10-2474

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