The topic at hand is Padsevonil (PSL), a drug in development that shows promise for treating patients with epilepsy and drug-resistant focal seizures. It is currently in Phase 2b / Phase 3 in clinical trials. Chanteaux explained how he and his team validated a method for the collection of PK samples in clinical studies of PSL using Mitra® blood microsampling devices.
The advantages of using Mitra devices in clinical trials are many. This method of precise, low-volume specimen collection reduces the burden both on clinical trial participants and on clinical operations, as well as allowing for more flexibility in recruitment and participation by introducing more convenient at-home and remote sampling.
In his presentation, Chanteux walks through his team’s methodology and delivers its results.
Bioanalytical Validation: The bioanalytical method was demonstrated to be accurate, precise, and selective for quantification of PSL over a clinically relevant concentration range (2-2000 ng/mL).
Bridging of Clinical Data: Blood PSL exposure was ~34% lower than plasma exposure This is in close agreement with the measured in vitro blood to plasma ratio of PSL (0.7).
With the bioanalytical method for quantification of PSL using microsampling successfully validated and PK data obtained with microsampling bridged with that from plasma, both in healthy study participants and patients with epilepsy, UCB Pharma has implemented the use of Mitra blood collection systems for collection of PK samples in global development studies.