NCT04283136

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

An Open-Label, Randomized, Single-Dose, 2-Part Crossover Study in Healthy Study Participants to Evaluate the Relative Bioavailability of 4 Padsevonil Product Variants and the Effect of Food on Padsevonil

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: UCB Biopharma SRL · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy Participants
• Epilepsy

Interventions

Type	Name	Description
DRUG	Padsevonil type 1 Tablet 200 mg	* Pharmaceutical form: Film-coated tablet * Route of administration: Oral use Subjects will receive a padsevonil type 1 tablet in a pre-specified sequence during the Treatment Period.
DRUG	Padsevonil type 2 Tablet	* Pharmaceutical form: Film-coated tablet * Route of administration: Oral use Subjects will receive a padsevonil type 2 tablet in a pre-specified sequence during the Treatment Period
DRUG	Padsevonil type 3 Tablet	* Pharmaceutical form: Film-coated tablet * Route of administration: Oral use Subjects will receive a padsevonil type 3 tablet in a pre-specified sequence during the Treatment Period.
DRUG	Padsevonil type 4 Tablet	* Pharmaceutical form: Film-coated tablet * Route of administration: Oral use Subjects will receive a padsevonil type 4 tablet in a pre-specified sequence during the Treatment Period.
DRUG	Padsevonil type 5 Tablet	* Pharmaceutical form: Film-coated tablet * Route of administration: Oral use Subjects will receive a padsevonil type 5 tablet in a pre-specified sequence during the Treatment Period.

Timeline

• Start date: 2020-02-24
• Primary completion: 2020-05-22
• Completion: 2020-05-22
• First posted: 2020-02-25
• Last updated: 2020-06-22

Regulatory

• FDA-regulated drug study