MedTrace Logo

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

NCT01209858 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2013-05-17

No results posted yet for this study

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.

Conditions

  • Partial Onset Epilepsy

Interventions

DRUG

Perampanel and Microgynon-30

Part A: Microgynon-30 single oral dose on Day 1 Period 1 and Day 35 Period 2; perampanel oral daily dose starting at 4 mg per day Period 2 from Days 1 through 35 and titrated weekly.

DRUG

Perampanel and Microgynon-30

Part B: Perampanel single oral dose of 6 mg on Day 1 Period 1 and Day 21 Period 2; Microgynon-30 orally from Day 1 through Day 21 of Period 2.

Sponsors & Collaborators

  • Eisai Inc.

    lead INDUSTRY

Principal Investigators

  • Prof Tim Mant · Quintiles, Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-03-31
Primary Completion
2010-10-31
Completion
2010-10-31

Countries

  • United Kingdom

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01209858 on ClinicalTrials.gov