Phase I Death in France: An Update on ANSM’s Investigations

New information from the National France Agency for medicines and Health Products Agency (ANSM) was published this week on the Phase I clinical trial halt last month after the death of a healthy volunteer and hospitalizations five others.

ANSM said Thursday it "is continuing its investigations in order to identify the factors that led to the tragic accident that occurred three weeks ago." The agency said this work is intended to complement other surveys of the judicial authorities, the French General Inspectorate of Social Affairs (General Inspectorate of Social Affairs) and the Ministry of Health.

The trial was the first in-human trial of the inhibitor of fatty acid amide hydrolase Bial and involved 128 healthy volunteers, 90 of them have received different doses of the drug.

Nineteen days after the contract research organization (CRO) Biotrial volunteers dosed with 20 mg of the study drug, the CRO began treatment with a dose of 50 mg on eight volunteers. On the fifth day of administration, on January 10, a volunteer was hospitalized, but it was not until 14 January that Biotrial ANSM informed of serious adverse events.

On January 11, a day after hospitalization, seven volunteers received another dose of 50 mg. The voluntary hospitalized in a coma later, on 11 and Biotrial and Bial promoter agreed to discontinue the trial. Five others were hospitalized between 13 and 15 January.

"All five volunteers hospitalized following the Bial study went home and two are being treated at centers close to home," Biotrial said on Twitter Friday. The company also said "no critical comments were reported by ANSM and we responded to all comments. "

ANSM ongoing investigations include:

•  Continuation of the inspection work performed on ANSM Rennes research center site, France;
•  Search for the medical causes that led to the death of a willful and serious consequences for the other four. For this, the ANSM said it has appointed clinical experts in charge of analyzing the available medical data collected to date;
• The creation of a temporary committee scientist (known as Temporary Specialized Scientific Committee), which includes French and European toxicology, pharmacology and neurology experts and clinicians.

ANSM said the special committee, created on January 21 will explore all the pharmacological and toxicological assumptions that could have led to the accident, including all pre-clinical and clinical data. On February 15, the committee will meet and ANSM said the list of experts and the agenda will be published at least two days before the meeting. The report of this committee will also be made public