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Trial record 42 of 89 for:    CARBAMAZEPINE AND Psychotropic

Pharmacokinetic Interaction Study Between Eslicarbazepine Acetate and Carbamazepine

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02284854
Recruitment Status : Completed
First Posted : November 6, 2014
Results First Posted : January 8, 2015
Last Update Posted : January 8, 2015
Sponsor:
Information provided by (Responsible Party):
Bial - Portela C S.A.

Tracking Information
First Submitted Date  ICMJE November 4, 2014
First Posted Date  ICMJE November 6, 2014
Results First Submitted Date  ICMJE December 9, 2014
Results First Posted Date  ICMJE January 8, 2015
Last Update Posted Date January 8, 2015
Study Start Date  ICMJE July 2009
Actual Primary Completion Date November 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 6, 2015)
  • Cmax (BIA 2-093) - the Maximum Plasma Concentration [ Time Frame: Day 7 to 35 ]
    Reference - Day 7 following once-daily oral administration of ESL 800 mg Test - Day 35 following once-daily oral administration of ESL 800 mg
  • Cmax (CBZ) - the Maximum Plasma Concentration [ Time Frame: Day 28 to 35 ]
    Reference - Day 28 following twice-daily oral administration of CBZ 400 mg Test - Day 35 following twice-daily oral administration of CBZ 400 mg
  • Cmax (CBZE) - the Maximum Plasma Concentration [ Time Frame: Day 28 to 35 ]
    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
  • AUC0-t (BIA 2-093) - Area Under the Curve to Last Measurable Concentration for BIA 2-093 [ Time Frame: Day 7 to 35 ]
    Reference - Day 7 following once-daily oral administration of ESL 800 mg Test - Day 35 following once-daily oral administration of ESL 800 mg
  • AUC0-t (CBZ) - Area Under the Curve to Last Measurable Concentration for CBZ [ Time Frame: Day 28 to 35 ]
    Reference - Day 28 following twice-daily oral administration of CBZ 400 mg Test - Day 35 following twice-daily oral administration of CBZ 400 mg
  • AUC0-t (CBZE) - Area Under the Curve to Last Measurable Concentration for CBZE [ Time Frame: Day 28 to 35 ]
    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
Original Primary Outcome Measures  ICMJE
 (submitted: November 4, 2014)
Cmax - the maximum plasma concentration [ Time Frame: Day 1 to 35 ]
Group A, Day 1, 5 and 6 before the ESL; Days 7 and 35: 5 minutes prior to dosing, and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 9, 12, 16 and 24 h after ESL administration; Days 8, 15, 21, 28 and 35: before the CBZ morning dose. Group B: before the CBZ dose on Day 1, 8, 15, 21 and 25, and at the following time-points on Days 28 and 35: within 5 minutes prior to dosing, and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 9 and 12 h after CBZ administration. Days 29, 33, 34 and 35 before the ESL dose
Change History Complete list of historical versions of study NCT02284854 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: November 4, 2014)
AUC0-t - the area under the plasma concentration-time curve from time zero to the last sampling time [ Time Frame: Day 1 to 35 ]
Group A, Day 1, 5 and 6 before the ESL; Days 7 and 35: 5 minutes prior to dosing, and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 9, 12, 16 and 24 h after ESL administration; Days 8, 15, 21, 28 and 35: before the CBZ morning dose. Group B: before the CBZ dose on Day 1, 8, 15, 21 and 25, and at the following time-points on Days 28 and 35: within 5 minutes prior to dosing, and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 9 and 12 h after CBZ administration. Days 29, 33, 34 and 35 before the ESL dose
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures
 (submitted: November 4, 2014)
tmax - the time of occurrence of Cmax [ Time Frame: Day 1 to 35 ]
Group A, Day 1, 5 and 6 before the ESL; Days 7 and 35: 5 minutes prior to dosing, and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 9, 12, 16 and 24 h after ESL administration; Days 8, 15, 21, 28 and 35: before the CBZ morning dose. Group B: before the CBZ dose on Day 1, 8, 15, 21 and 25, and at the following time-points on Days 28 and 35: within 5 minutes prior to dosing, and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 9 and 12 h after CBZ administration. Days 29, 33, 34 and 35 before the ESL dose
 
Descriptive Information
Brief Title  ICMJE Pharmacokinetic Interaction Study Between Eslicarbazepine Acetate and Carbamazepine
Official Title  ICMJE Pharmacokinetic Interaction Study Between Eslicarbazepine Acetate and Carbamazepine in Healthy Subject
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.
Detailed 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Epilepsy
Intervention  ICMJE
  • Drug: BIA 2-093
    Other Names:
    • Eslicarbazepine acetate
    • ESL
  • Drug: Carbamazepine
    Other Name: CBZ
Study Arms  ICMJE
  • Experimental: Group A
    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
    Interventions:
    • Drug: BIA 2-093
    • Drug: Carbamazepine
  • Experimental: Group B
    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
    Interventions:
    • Drug: BIA 2-093
    • Drug: Carbamazepine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 4, 2014)
43
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2009
Actual Primary Completion Date November 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02284854
Other Study ID Numbers  ICMJE BIA-2093-129
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bial - Portela C S.A.
Study Sponsor  ICMJE Bial - Portela C S.A.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Bial - Portela C S.A.
Verification Date January 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP