drugset / Trial / NCT04283136

A Study to Test the Blood Concentration of 4 Padsevonil Product Variants and the Effect of Food on Padsevonil

NCT04283136

Phase 1 Withdrawn UCB Biopharma SRL
RandomizedCrossoverOpen-labelBasic science

Summary

The purpose of the study in Part 1, is to evaluate (under fasted conditions) the plasma pharmacokinetics (PK) of padsevonil (PSL) using 4 PSL product variants against a PSL reference tablet and in Part 2, to evaluate the PK of PSL using a PSL reference tablet under fed and fasted conditions at 200 mg and 400 mg.

Timeline

Start
2020-02-24
Primary completion
2020-05-22
Completion
2020-05-22

Drugs

EvaluationDrugModalityDoseRoute
Comparator Padsevonil Small molecule 200 mg Oral
Comparator Padsevonil Small molecule 400 mg Oral

Indications