drugset / Trial / NCT01209858

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

NCT01209858

Phase 1 Completed 48 enrolled Eisai Inc.
Non-randomizedSingle-groupOpen-labelTreatment

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.

Timeline

Start
2010-03
Primary completion
2010-10
Completion
2010-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Microgynon 30® Unknown Oral
Subject Perampanel Small molecule 4 mg Oral
Subject Perampanel Small molecule 6 mg Oral