Ignite Creation Date:
2025-12-25 @ 12:13 AM
Ignite Modification Date:
2025-12-25 @ 10:14 PM
Study NCT ID:
NCT01209858
Status:
COMPLETED
Last Update Posted:
2013-05-17
First Post:
2010-09-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study to Investigate the Potential Pharmacokinetic Interaction of Perampanel With Oral Contraceptives in Healthy Female Subjects
Sponsor:
Eisai Inc.
Organization:
Study Overview
Official Title:
A Open-label Study to Investigate the Potential Pharmacokinetic Interaction of Perampanel With Oral Contraceptives in Healthy Female Subjects
Status:
COMPLETED
Status Verified Date:
2013-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to investigate the effects of perampanel on the pharmacokinetics (PK) of a single-dose oral contraceptive (OC)containing ethinylestradiol (EE) and levonorgestrel (LN) (Microgynon-30) and to investigate the effects of repeated dosing of OC containing EE and LN (Microgynon-30) on the PK of a single dose of perampanel.
Detailed Description:
This will be an open-label, non-randomized, fixed sequence study in healthy female subjects. The study has 2 parts: Part A investigating the effects of steady state perampanel on the pharmacokinetics (PK) of a single-dose oral contraceptive (OC) containing ethinylestradiol (EE) and levonorgestrel (LN) (Microgynon-30) and Part B investigating the effects of repeated dosing of an OC containing EE and LN (Microgynon-30) on the PK of a single dose of perampanel.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: