Pharmacokinetic Interaction Study Between Eslicarbazepine Acetate and Carbamazepine

NCT02284854 | Completed Phase 1 Results

• 1 other identifier: BIA-2093-129
• Study Type: interventional
• Target: 43
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Epilepsy

Outcome Measures

Primary Outcomes (6)

• 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

• 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

• 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

• 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

• 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

• 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

Study Arms (2)

Group A

EXPERIMENTAL

Day 1 to Day 8 - BIA 2-093 800 mg Day 9 to Day 14 - BIA 2-093 800 mg + CBZ 200 mg Day 15 to Day 22 - BIA 2-093 800 mg + CBZ 400 mg Day 23 to Day 35 - BIA 2-093 800 mg + CBZ 400 mg twice-daily

Drug: BIA 2-093; Drug: Carbamazepine

Group B

EXPERIMENTAL

Day 1 to Day 8 - CBZ 200 mg Day 9 to Day 14 - CBZ 400 mg Day 15 to Day 29 - CBZ 400 mg twice-daily Day 30 to Day 35 - BIA 2-093 800 mg + CBZ 400 mg twice-daily

Drug: BIA 2-093; Drug: Carbamazepine

Interventions

BIA 2-093 DRUG

Also known as: Eslicarbazepine acetate, ESL

Group A; Group B

Carbamazepine DRUG

Also known as: CBZ

Group A; Group B

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bial - Portela C S.A.: lead

MeSH Terms

Conditions

Epilepsy

Interventions

eslicarbazepine acetate; Carbamazepine

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Dibenzazepines; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

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: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2014
• First Posted: November 6, 2014
• Study Start: July 1, 2009
• Primary Completion: November 1, 2009
• Study Completion: November 1, 2009
• Last Updated: January 8, 2015
• Results First Posted: January 8, 2015

Record last verified: 2015-01