Food Effect and Dosage Form Proportionality Study of Eslicarbazepine Acetate

• ClinicalTrials.gov Identifier: NCT02288312
• Recruitment Status: Completed
• First Posted: November 11, 2014
• Results First Posted: January 8, 2015
• Last Update Posted: January 8, 2015
• Sponsor: Bial - Portela C S.A.
• Information provided by (Responsible Party): Bial - Portela C S.A.

Study Description

Brief Summary:

Single-centre, open-label, randomised, gender-balanced, 3-way crossover, 3-period, 3-sequence study in 18 healthy male and female subjects.

Condition or disease	Intervention/treatment	Phase
Epilepsy	Drug: BIA 2-093	Phase 1

Detailed Description:

Single-centre, open-label, randomised, gender-balanced, 3-way crossover, 3-period, 3-sequence study in 18 healthy male and female subjects. The study consisted of 3 periods separated by a washout of 7 days or more between doses. Subjects received a single oral 800 mg dose of eslicarbazepine acetate following a standard meal in one period, and following at least 10 hours of fasting in two periods.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 18 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Food Effect and Dosage Form Proportionality Study of Eslicarbazepine Acetate Market Formulation in Healthy Volunteers
• Study Start Date: May 2007
• Actual Primary Completion Date: July 2007
• Actual Study Completion Date: July 2007

Arms and Interventions

Arm	Intervention/treatment
Experimental: BIA 2-093 800 mg fasting; Tablets 800 mg. Administration:Oral.	Drug: BIA 2-093; Other Name: ESL, Eslicarbazepine acetate
Experimental: BIA 2-093 800 mg fed; Tablets 800 mg. Administration:Oral.	Drug: BIA 2-093; Other Name: ESL, Eslicarbazepine acetate
Experimental: BIA 2-093 400 mg; Tablets 2 x 400 mg. Administration:Oral.	Drug: BIA 2-093; Other Name: ESL, Eslicarbazepine acetate

Outcome Measures

Primary Outcome Measures :

1. Cmax (BIA 2-005) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours postdose. ]
   Cmax (BIA 2-005) - maximum observed plasma drug concentration of BIA 2-005 (BIA 2-093 metabolite)

Secondary Outcome Measures :

1. AUC0-t (BIA 2-005) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours postdose. ]
   AUC0-t (BIA 2-005) - the area under the plasma concentration-time curve from time zero to the last sampling time at which BIA 2-005 concentrations are at or above the limit of quantification, calculated by the linear trapezoidal rule (BIA 2-005 is a BIA 2-093 metabolite)
2. Tmax (BIA 2-005) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours postdose. ]
   tmax (BIA 2-005) - the time of occurrence of Cmax of BIA 2-005 (BIA 2-005 is a BIA 2-093 metabolite)
3. AUC0-∞ (BIA 2-005) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours postdose. ]
   AUC0-∞ (BIA 2-005) - the area under the plasma BIA 2-005 concentration versus time curve from time zero to infinity, calculated from AUC0-t + (Clast/λz), where Clast is the last quantifiable concentration and λz the apparent terminal rate constant; (BIA 2-005 is a BIA 2-093 metabolite)

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 55 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

• Male or female subjects aged between 18 and 55 years, inclusive.
• Subjects of body mass index (BMI, kg/m2) within the normal range [4], i.e., between 18.50 and 24.99, inclusive.
• Subjects who were healthy as determined by pre-study medical history, physical examination, vital signs, and 12-lead ECG.
• Subjects who had clinical laboratory test results clinically acceptable at screening and admission to first treatment period.
• Subjects who had negative tests for HBsAg, anti-HCVAb and anti- HIV-1 and HIV-2 Ab at screening.
• Subjects who had a negative screen for alcohol and drugs of abuse at screening.
• Subjects who were non-smokers or ex-smokers who discontinued smoking at least 3 months prior to admission.
• Subjects who were able and willing to give written informed consent.
• (If female) She was not of childbearing potential by reason of surgery (hysterectomy or tubal ligation) or, if of childbearing potential, she used one of the following methods of contraception: intrauterine device (by the study subject) + condom (by the partner), diaphragm (by the study subject) + condom (by the partner), or spermicide (by the study subject) + condom (by the partner).
• (If female) She had a negative urine pregnancy test at screening and admission to each treatment period.

Exclusion Criteria:

• Subjects who did not conform to the above inclusion criteria, or
• Subjects who had a clinically relevant history or presence of respiratory, gastrointestinal, renal, hepatic, haematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, endocrine, connective tissue diseases or disorders.
• Subjects who had a clinically relevant surgical history.
• Subjects who had a clinically relevant family history.
• Subjects who had a history of relevant drug hypersensitivity.
• Subjects who had a history of alcoholism or drug abuse.
• Subjects who consumed more than 14 units of alcohol a week.
• Subjects who used medicines within 2 weeks of first admission that, in the opinion of the investigator, may affect the safety or other study assessments.
• Subjects who used any investigational drug or participated in any clinical trial within 2 months of their first admission.
• Subjects who had previously received eslicarbazepine acetate (ESL, BIA 2-093).
• Subjects who donated or received any blood or blood products within the previous 2 months prior to screening.
• Subjects who were vegetarians, vegans or have medical dietary restrictions.
• Subjects who could not 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 give written informed consent.
• (If female) She was pregnant or breast-feeding.
• (If female) She was of childbearing potential and she did not used and approved effective contraceptive method or she used oral contraceptives.

Contacts and Locations

No Contacts or Locations Provided

More Information

• Responsible Party: Bial - Portela C S.A.
• ClinicalTrials.gov Identifier: NCT02288312
• Other Study ID Numbers: BIA-2093-117
• First Posted: November 11, 2014
• Results First Posted: January 8, 2015
• Last Update Posted: January 8, 2015
• Last Verified: December 2014

Additional relevant MeSH terms:

Epilepsy; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Eslicarbazepine acetate; Anticonvulsants; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action