Pharmacokinetic Interaction Study Between Eslicarbazepine Acetate and Carbamazepine

Epilepsy Clinical Trial

Official title:

Pharmacokinetic Interaction Study Between Eslicarbazepine Acetate and Carbamazepine in Healthy Subject

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02284854
• Other study ID #: BIA-2093-129
• Status: Completed
• Phase: Phase 1
• First received: November 4, 2014
• Last updated: January 6, 2015
• Start date: July 2009
• Est. completion date: November 2009

Study information

• Verified date: January 2015
• Source: Bial - Portela C S.A.
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial Summary

Open-label study in two parallel groups of 20 healthy subjects each. Group A assessed the effect of CBZ on ESL pharmacokinetics, and Group B assessed the effect of ESL on CBZ pharmacokinetics.

Description:

Open-label study in two parallel groups of 20 healthy subjects each. Group A assessed the effect of CBZ on ESL pharmacokinetics, and Group B assessed the effect of ESL on CBZ pharmacokinetics. Each patient participated in the study for approximately 9 weeks. The clinical portion of the study was completed in approximately 3 months. Subjects received the treatments during 35 days.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: November 2009
• Est. primary completion date: November 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Male and female subjects aged 18 to 45 years inclusive;

• Body mass index (BMI) between 18 and 30 kg/m2 inclusive;

• Healthy as determined by pre-study medical history, physical examination, vital signs, and 12-lead electrocardiogram (ECG); negative tests for Hepatitis B surface Antigen (HBsAg), anti-HCVAb and Human Immunodeficiency Virus (HIV)-1 and HIV-2 Ab at screening;

• Clinical laboratory test results clinically acceptable at screening and admission to each treatment period;

• Negative screen for alcohol and drugs of abuse at screening and admission to each treatment period;

• Non-smokers or ex-smokers;

• Able and willing to give written informed consent;

• If female, not of childbearing potential by reason of surgery or, if of childbearing potential, she used a double-barrier method of contraception: 1 male barrier method [male condom] plus 1 female barrier method (diaphragm, spermicide, or intrauterine device);

• If female, had a negative urine pregnancy test at screening and admission to each treatment period.

Exclusion Criteria:

• 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; have a clinically relevant surgical history;

• History of relevant atopy or any drug hypersensitivity (including known hypersensitivity to ESL or other carboxamide derivatives [e.g., carbamazepine, oxcarbazepine] or any of its excipients; known hypersensitivity to drugs structurally related to carbamazepine [e.g.: tricyclic antidepressants] or any of its excipients);

• Second or third-degree atrioventricular blockade not corrected with a pace-maker or any other clinically significant abnormality in the 12-lead ECG as determined by the investigator;

• History of alcoholism or drug abuse;

• Consumed more than 14 units1 of alcohol a week;

• Significant infection or known inflammatory process on screening or admission to each treatment period;

• Acute gastrointestinal symptoms (e.g., nausea, vomiting, diarrhoea, heartburn) at the time of screening or admission to each treatment period;

• Use of medicines within two weeks of admission to first period that may affect the safety or other study assessments, in the investigator's opinion;

• Had donated or received any blood or blood products within the 3 months prior to screening;

• Vegetarians, vegans or have other medical dietary restrictions;

• Could not communicate reliably with the investigator; was unlikely to co-operate with the requirements of the study;

• Unwilling or unable to give written informed consent;

• If female, was pregnant or breast-feeding;

• If female, was of childbearing potential and did not use an accepted effective contraceptive method or used hormonal contraceptives;

• Had received an investigational drug within 3 months of screening or was currently participating in another study.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Epilepsy

Intervention

Drug:
• BIA 2-093

• Carbamazepine

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bial - Portela C S.A.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cmax (BIA 2-093) - the Maximum Plasma Concentration	Reference - Day 7 following once-daily oral administration of ESL 800 mg Test - Day 35 following once-daily oral administration of ESL 800 mg	Day 7 to 35	No
Primary	Cmax (CBZ) - the Maximum Plasma Concentration	Reference - Day 28 following twice-daily oral administration of CBZ 400 mg Test - Day 35 following twice-daily oral administration of CBZ 400 mg	Day 28 to 35	No
Primary	Cmax (CBZE) - the Maximum Plasma Concentration	Reference - Day 28 following twice-daily oral administration of CBZ 400 mg twice-daily Test - Day 35 following twice-daily oral administration of CBZ 400 mg twice-daily; CBZE - carbamazepine-epoxide is the active metabolite of CBZ	Day 28 to 35	No
Primary	AUC0-t (BIA 2-093) - Area Under the Curve to Last Measurable Concentration for BIA 2-093	Reference - Day 7 following once-daily oral administration of ESL 800 mg Test - Day 35 following once-daily oral administration of ESL 800 mg	Day 7 to 35	No
Primary	AUC0-t (CBZ) - Area Under the Curve to Last Measurable Concentration for CBZ	Reference - Day 28 following twice-daily oral administration of CBZ 400 mg Test - Day 35 following twice-daily oral administration of CBZ 400 mg	Day 28 to 35	No
Primary	AUC0-t (CBZE) - Area Under the Curve to Last Measurable Concentration for CBZE	Reference - Day 28 following twice-daily oral administration of CBZ 400 mg Test - Day 35 following twice-daily oral administration of CBZ 400 mg; CBZE - carbamazepine-epoxide is the active metabolite of CBZ	Day 28 to 35	No