Food Effect and Dosage Form Proportionality Study of Eslicarbazepine Acetate

NCT02288312 | Completed Phase 1 Results

• 1 other identifier: BIA-2093-117
• Study Type: interventional
• Target: 18
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Epilepsy

Outcome Measures

Primary Outcomes (1)

• Cmax (BIA 2-005)

  Cmax (BIA 2-005) - maximum observed plasma drug concentration of BIA 2-005 (BIA 2-093 metabolite)

  pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours postdose.

Secondary Outcomes (3)

• AUC0-t (BIA 2-005)

  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)

  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)

  pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours postdose.

Study Arms (3)

BIA 2-093 800 mg fasting

EXPERIMENTAL

Tablets 800 mg. Administration:Oral.

Drug: BIA 2-093

BIA 2-093 800 mg fed

EXPERIMENTAL

Tablets 800 mg. Administration:Oral.

Drug: BIA 2-093

BIA 2-093 400 mg

EXPERIMENTAL

Tablets 2 x 400 mg. Administration:Oral.

Drug: BIA 2-093

Interventions

BIA 2-093 DRUG

Also known as: ESL, Eslicarbazepine acetate

BIA 2-093 400 mg; BIA 2-093 800 mg fasting; BIA 2-093 800 mg fed

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bial - Portela C S.A.: lead

MeSH Terms

Conditions

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

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

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: November 7, 2014
• First Posted: November 11, 2014
• Study Start: May 1, 2007
• Primary Completion: July 1, 2007
• Study Completion: July 1, 2007
• Last Updated: January 8, 2015
• Results First Posted: January 8, 2015

Record last verified: 2014-12