French group outlines first-in-man trial precautions

A special committee created by the French National Agency for Medicines and Health Products Safety (ANSM) made initial recommendations for first-in-man trials following a death and several hospitalizations of healthy volunteers in a Phase I study of oral analgesic BIA 10-2474, a fatty acid amide hydrolase ( FAAH) inhibitor from Bial-Portela & Ca. S.A. (S. Mamede do Coronado, Portugal).

In minutes from a meeting held last month and released this week, the Temporary Specialist Scientific Committee (TSSC) recommended that a therapy show preclinical pharmacological activity that is "comparative whenever possible" and "reasonably predictive of real-life, future therapeutic efficacy" before human testing begins. It also said "more reasonable and careful practices" should be established by consensus for dose escalation in Phase I trials. ...