The Effect of BIA 2-093 on the Steady-state Pharmacokinetic Profile of Phenytoin in Patients

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01878578
• Date of registration: 12/06/2013
• Prospective Registration: No
• Primary sponsor: Bial - Portela C S.A.
• Public title: The Effect of BIA 2-093 on the Steady-state Pharmacokinetic Profile of Phenytoin in Patients
• Date of first enrolment: November 2002
• Target sample size: 4
• Recruitment status: Terminated
• URL: http://clinicaltrials.gov/show/NCT01878578
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
• Phase: Phase 1

Countries of recruitment

Portugal

Key inclusion & exclusion criteria

Inclusion Criteria:

- Male or female subjects aged between 18 and 65 years, inclusive.

- Subjects who were on an established regimen of phenytoin monotherapy, which had been
stable for at least 3 months.

- Subjects who had clinical laboratory tests acceptable to the Investigator.

- Subjects who were negative for hepatitis B surface antigen (HBsAg), hepatitis C virus
(HCV) antibody (Ab) and human immunodeficiency viruses (HIV-1 and HIV-2) Ab tests at
screening.

- Subjects who were negative for alcohol and drugs of abuse at screening.

- Subjects who were non-smokers or who smoked less than 10 cigarettes or equivalent per
day.

- Subjects who were able and willing to gave written informed consent.

- (If female) She was not of childbearing potential by reason of surgery or, if of
childbearing potential, she used one of the following methods of contraception:
double barrier or intrauterine device.

- (If female) She had a negative pregnancy test at screening.

Exclusion Criteria:

- Subjects who did not conform to the above inclusion criteria.

- Subjects who had a clinically relevant history or presence of any disease that may
interfere with the pharmacokinetics or pharmacodynamics of the Investigational
Products, or may affect its safety.

- Subjects who had a history of relevant drug hypersensitivity.

- Subjects who had a history of alcoholism or drug abuse in the last 2 years.

- Subjects who consumed more than 21 units of alcohol a week.

- Subjects who had one of the following findings on the electrocardiogram (ECG): sinus
bradycardia, sinoatrial block, atrioventricular block of any degree.

- Subjects who had a significant infection or known inflammatory process on screening
and/or admission.

- Subjects who had acute gastrointestinal symptoms at the time of screening and/or
admission (e.g., nausea, vomiting, diarrhoea, heartburn).

- Subjects who had used any drugs (other than phenytoin) that may affect the
pharmacokinetic profile of the investigational products within 2 weeks of first
dosing.

- Subjects who had used any investigational drug and/or participated in any clinical
trial within 3 months of their first admission to this study.

- Subjects who had previously received ESL.

- Subjects who had donated and/or received any blood or blood products within the
previous 3 months prior to screening.

- Subjects who were vegetarians, vegans and/or have medical dietary restrictions.

- Subjects who cannot communicate reliably with the investigator.

- Subjects who were unlikely to co-operate with the requirements of the study.

- Subjects who were unwilling or unable to gave written informed consent.

- (If female) She was pregnant or breast-feeding.

- (If female) She was of childbearing potential and she did not use an approved
effective contraceptive method.



Age minimum: 18 Years
Age maximum: 65 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Epilepsy

Intervention(s)

Drug: Eslicarbazepine acetate

Drug: phenytoin

Drug: Placebo

Primary Outcome(s)

Number of Adverse Events reported [Time Frame: 3 weeks]

Secondary ID(s)

BIA-2093-106

Source(s) of Monetary Support

Please refer to primary and secondary sponsors