Document : le protocole de l’essai clinique de Rennes

BIAL – Portela & Cª, S.A. Avenida da Siderurgia Nacional 4745-457 Coronado (S. Romão e S. Mamede) Portugal EudraCT N°: 2015-001799-24 Clinical Study Protocol N° BIA-102474-101 Biotrial Code: 1BIAL35 A 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 Investigational Medicinal Product Code: Development Phase: Principal Investigator: Didier Chassard, MD Biotrial 7-9 rue Jean-Louis Bertrand, CS 34246 35042 Rennes Cedex France Version 2.0 BIA 10-2474 I Sponsor: José Francisco Rocha, BSc. BIAL – Portela & Cª, S.A. R&D Department Avenida da Siderurgia Nacional 4745-457 Coronado (S. Romão e S. Mamede) Portugal Tel.: +351 22 9866100 Fax.: +351 22 9866192 Email: francisco.rocha@bial.com Date: 16 October 2015 This information may not be used,published or otherwise disclosed without prior written authorisation from the sponsor Study Protocol BIA-102474-101 1BIAL35 / Version 2.0 / 16 October 2015 1. SYNOPSIS -CONFIDENTIAL- Page 3 Name of Company: BIAL-Portela & Cª, S.A. À Avenida da Siderurgia Nacional, 4745-457 Coronado (S. Romão e S.