Ignite Creation Date:
2024-05-06 @ 1:49 PM
Last Modification Date:
2024-10-26 @ 1:20 PM
Study NCT ID:
NCT04131517
Status:
TERMINATED
Last Update Posted:
2021-06-24
First Post:
2019-10-16
Brief Title:
A Study to Test the Interaction of Padsevonil With Oral Contraceptives in Healthy Female Participants
Sponsor:
UCB Biopharma SRL
Organization:
UCB Pharma
Study Overview
Official Title:
An Open-Label Randomized Two-Way Crossover Study to Investigate the Potential Pharmacokinetic Interaction of Padsevonil With Oral Contraceptives in Healthy Female Participants
Status:
TERMINATED
Status Verified Date:
2021-06
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 is to investigate the effect of steady-state padsevonil on the pharmacokinetic of a single dose oral contraceptive
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?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2019-002194-54 | EUDRACT_NUMBER | None | None |