A Clinical Phase I Study on GIC-1001 in Healthy Volunteers

Summary

The objectives of this single center, randomized, double-blinded, placebo-controlled Phase I clinical study are to evaluate the safety and tolerability of five (5) single and four (4) multiple increasing oral doses of GIC-1001 compared to placebo, and to evaluate the pharmacokinetics of GIC-1001 following single and multiple-dose administration in 80 healthy, 18-50 years old male and female subjects. Moreover, the effect of food on the pharmacokinetics of GIC-1001 in healthy subjects will be assessed. This study is designed with an integrated, adaptive approach which allows the evaluation of single and multiples doses of GIC-1001 in a progressive, overlapped fashion.

Timeline

Start

2012-11

Primary completion

2013-04

Completion

2013-05

Publications

• Paquette JM, Rufiange M, Iovu Niculita M, Massicotte J, Lefebvre M, Colin P, Telmat A, Ranger M. Safety, tolerability and pharmacokinetics of trimebutine 3-thiocarbamoylbenzenesulfonate (GIC-1001) in a randomized phase I integrated design study: single and multiple ascending doses and effect of food in healthy volunteers. Clin Ther. 2014 Nov 1;36(11):1650-64. doi: 10.1016/j.clinthera.2014.08.005. Epub 2014 Sep 15.

Drugs

Indications