Effect of Repeat Administration of Eslicarbazepine Acetate on the Pharmacokinetics of a Combined Oral Contraceptive

NCT00898560 | Completed Phase 1 Results DMC

• 1 other identifier: BIA-2093-128
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to investigate whether multiple-dose administration of eslicarbazepine acetate (ESL, BIA 2-093) 800 mg once-daily (QD) affects the pharmacokinetics and tolerability of the components of a combined oral contraceptive (ethinyloestradiol and levonorgestrel).

Conditions

Partial Epilepsy

Keywords

Partial; Epilepsy; Eslicarbazepine acetate; Combined oral contraceptive; Pharmacokinetics; Tolerability

Outcome Measures

Primary Outcomes (1)

• Cmax - Maximum Observed Plasma Concentration

  To investigate whether multiple-dose administration of eslicarbazepine acetate (ESL, BIA 2-093) 800 mg once-daily (QD) affects the pharmacokinetics of the components of a combined oral contraceptive (ethinyloestradiol and levonorgestrel).

  15-day

Secondary Outcomes (2)

• AUC0-t - Area Under the Plasma Concentration Versus Time Curve From Time Zero to the Last Sampling Time at Which Concentrations Were at or Above the Limit of Quantification

  15-day

• AUC0-∞ - Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity

  15-day

Study Arms (2)

Microginon®

OTHER

A single oral dose of a combined oral contraceptive containing 30ug ethinyloestradiol and 150ug levonorgestrel (Microginon ®).

Drug: Microginon®

ESL and Microginon®

EXPERIMENTAL

15-day treatment with ESL 800 mg once daily, with co administration of a single oral dose of Microginin® on Day 14 of the relevant dosing period, to assess impact of ESL on pharmacokinetics of the combined oral contraceptive.

Drug: eslicarbazepine acetate and Microginon®

Interventions

eslicarbazepine acetate and Microginon® DRUG

eslicarbazepine acetate: once-daily oral dose of 800 mg on days 1- 15 of treatment period. Microginon®: single oral dose on day 14 of treatment period

Also known as: ESL, BIA 2-093

ESL and Microginon®

Microginon® DRUG

Single oral dose of Microginon® (30ug ethinyloestradiol and 150ug levonorgestrel)

Microginon®

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Pre-menopausal female subjects
• Age 18-40 years, inclusive
• Body mass index (BMI) 19-30 kg/m2, inclusive
• Healthy as determined by pre-study medical history, physical examination, vital signs, complete neurological examination and 12-lead ECG
• Negative tests for HBsAg, anti-HCVAb and HIV-1 and HIV-2 Ab at screening
• Negative urine pregnancy test at screening and admission to each treatment period.
• Using one of the following methods of contraception: double barrier or intrauterine device

You may not qualify if:

• Subjects who have any contra-indication to the use of oral contraceptives
• History or presence of clinically relevant diseases, disorders or surgical history
• History of alcoholism or drug abuse
• Have used medicines within two weeks of admission to first period that may affect the safety or other study assessments, in the investigator's opinion

Sponsors & Collaborators

• Bial - Portela C S.A.: lead

Study Sites (1)

Human Pharmacology Unit (UFH), Section of Clinical Research (SIC), Department of Research & Development (DID), BIAL - Portela & Cª, SA, S. Mamede do Coronado

Porto, 4745-457, Portugal

Location

MeSH Terms

Conditions

Epilepsies, Partial; Epilepsy

Interventions

eslicarbazepine acetate

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Results Point of Contact

• Title: Head of Clinical Research
• Organization: Bial - Portela & Cª, S.A.

jose.rocha@bial.com

+351 229 866 100

Study Officials

• Manuel Vaz-da-Silva

  Bial Portela

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2009
• First Posted: May 12, 2009
• Study Start: September 1, 2008
• Primary Completion: November 1, 2008
• Study Completion: November 1, 2008
• Last Updated: December 12, 2014
• Results First Posted: December 12, 2014

Record last verified: 2014-12

Locations

PT (1)