Ignite Creation Date:
2024-05-06 @ 2:19 PM
Last Modification Date:
2024-10-26 @ 1:29 PM
Study NCT ID:
NCT04283136
Status:
WITHDRAWN
Last Update Posted:
2020-06-22
First Post:
2020-02-21
Brief Title:
A Study to Test the Blood Concentration of 4 Padsevonil Product Variants and the Effect of Food on Padsevonil
Sponsor:
UCB Biopharma SRL
Organization:
UCB Pharma
Study Overview
Official Title:
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WITHDRAWN
Status Verified Date:
2020-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Based on available data UCB has decided to stop development of padsevonil as adjunctive treatment of focal-onset seizures
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None