Who is sponsoring NCT01209858?

NCT01209858 is sponsored by Eisai Inc..

What condition does NCT01209858 study?

NCT01209858 studies Partial Onset Epilepsy.

What drugs are being tested in NCT01209858?

Interventions: Perampanel and Microgynon-30, Perampanel and Microgynon-30.

What is the status of NCT01209858?

NCT01209858 is currently COMPLETED.

Last reviewed 2013-05-15 · How we verify

A Open-label Study to Investigate the Potential Pharmacokinetic Interaction of Perampanel With Oral Contraceptives in Healthy Female Subjects

NCT01209858 Phase 1 COMPLETED

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.

Details

Lead sponsor	Eisai Inc.
Phase	Phase 1
Status	COMPLETED
Enrolment	48
Start date	2010-03
Completion	2010-10

Conditions

Partial Onset Epilepsy

Interventions

Perampanel and Microgynon-30
Perampanel and Microgynon-30

Primary outcomes

Part A: Pharmacokinetics (PK) of ethinylestradiol (EE) and levonorgestrel (LN) — Up to 24 hours postdose on Days 1 (Tr Pd 1) and 35 (Tr Pd 2).
Part B: Pharmacokinetics (PK) of perampanel — Up to 72 hours postdose on Days 1 (Tr Pd 1) and 21 (Tr Pd 2).

Countries

United Kingdom