Steady-state Pharmacokinetics of BIA 2-093 and Oxcarbazepine in Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bial - Portela C S.A.
ClinicalTrials.gov Identifier:
NCT01679002
First received: August 31, 2012
Last updated: December 31, 2014
Last verified: December 2014
  Purpose

To investigate the steady-state pharmacokinetics of once-daily and twice-daily regimens of BIA 2-093 and twice-daily regimen of Oxcarbazepine (Trileptal®) in healthy subjects and to assess the tolerability of such regimens in healthy subjects.


Condition Intervention Phase
Epilepsy
Drug: BIA 2-093
Drug: Oxcarbazepine
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Steady-state Pharmacokinetics of BIA 2-093 and Oxcarbazepine in Healthy Volunteers

Resource links provided by NLM:


Further study details as provided by Bial - Portela C S.A.:

Primary Outcome Measures:
  • Cmax - Maximum Observed Plasma Drug Concentration [ Time Frame: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48, 72 and 96 h post-dose ] [ Designated as safety issue: No ]

    Cmax - maximum observed plasma drug concentration for BIA 2-093 metabolites:

    BIA 2-194 BIA 2-195 Oxcarbazepine



Secondary Outcome Measures:
  • AUC - Area Under the Plasma Concentration Versus Time Curve [ Time Frame: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48, 72 and 96 h post-dose ] [ Designated as safety issue: No ]

    AUC - Area Under the Plasma Concentration Versus Time Curve for BIA 2-093 metabolites:

    BIA 2-194 BIA 2-195 Oxcarbazepine


  • Number of of Subjects Reporting at Least One Adverse Event [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
    Number of of subjects reporting at least one adverse event.


Enrollment: 12
Study Start Date: October 2003
Study Completion Date: December 2003
Primary Completion Date: December 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A

BIA 2-093 900 mg once-daily period followed by BIA 2-093 450 mg twice-daily period followed by oxcarbazepine 450 mg twice-daily period

BIA 2-093 450 mg od - BIA 2-093 450 mg bid - OXC 900 mg bid

Drug: BIA 2-093
Other Name: ESL, Eslicarbazepine acetate
Drug: Oxcarbazepine
Other Name: OXC, Trileptal®
Experimental: Group B

BIA 2-093 450 mg twice-daily period followed by oxcarbazepine 450 mg twice-daily period followed by BIA 2-093 900 mg once-daily period

BIA 2-093 450 mg bid - OXC 450 mg bid - BIA 2-093 900 mg od

Drug: BIA 2-093
Other Name: ESL, Eslicarbazepine acetate
Drug: Oxcarbazepine
Other Name: OXC, Trileptal®
Experimental: Group C

oxcarbazepine 450 mg twice-daily period followed by BIA 2-093 900 mg once-daily period followed by BIA 2-093 450 mg twice-daily period

OXC 450 mg bid - BIA 2-093 900 mg od - BIA 2-093 450 mg bid

Drug: BIA 2-093
Other Name: ESL, Eslicarbazepine acetate
Drug: Oxcarbazepine
Other Name: OXC, Trileptal®

Detailed Description:

Single centre, open-label, randomised, three-way crossover study in 12 healthy volunteers. The study consisted of three 8-day treatment periods separated by washout periods of 10-15 days. On each of the treatment periods the volunteers received either a daily oral dose of BIA 2-093 900 mg once-daily (od), BIA 2-093 450 mg twice-daily (bid), or Oxcarbazepine (Trileptal®) 450 mg bid.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subjects were eligible for entry into the study if they fulfilled the following inclusion criteria:
  • Male or female subjects aged between 18 and 45 years, inclusive.
  • Subjects of body mass index (BMI) between 19 and 28 kg/m2, inclusive.
  • Subjects who were healthy as determined by pre-study medical history, physical examination, neurological examination, and 12-lead ECG.
  • Subjects who had clinical laboratory tests clinically acceptable.
  • Subjects who were negative for HBsAg, anti-HCV Ab and HIV-1 and HIV-2 Ab tests at screening.
  • Subjects who were negative for alcohol and drugs of abuse at screening and first admission.
  • Subjects who were non-smokers or who smoked less than 10 cigarettes or equivalent per day.
  • Subjects who were able and willing to give written informed consent.
  • If case of female subjects, subjects who were not of childbearing potential by reason of surgery or, if of childbearing potential, who used one of the following methods of contraception: double-barrier, intrauterine device or abstinence.
  • If case of female subjects, subjects who had a negative pregnancy test at screening and first admission.

Exclusion Criteria:

  • Subjects who did not conform to the above inclusion criteria.
  • 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 atopy.
  • Subjects who had a history of hypersensitivity to carbamazepine or oxcarbazepine or any other 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 had a significant infection or known inflammatory process on screening and/or first admission.
  • Subjects who had acute gastrointestinal symptoms at the time of screening and/or first admission (e.g., nausea, vomiting, diarrhoea, heartburn).
  • Subjects who had used prescription or over-the-counter medication within two weeks of first admission.
  • Subjects who had used any investigational drug and/or participated in any clinical trial within four months of their first admission.
  • Subjects who had previously received BIA 2-093.
  • Subjects who had donated and/or received any blood or blood products within the previous 4 months prior to screening.
  • Subjects who were vegetarians, vegans and/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.
  • In case of female subjects, subjects who were pregnant or breast-feeding.
  • In case of female subjects, subjects who were of childbearing potential and did not use an approved effective contraceptive method or used oral contraceptives.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01679002

Locations
Portugal
BIAL - Portela & Cª S.A. - Human Pharmacology Unit (UFH)
S. Mamede do Coronado, Trofa, Portugal, 4745-457
Sponsors and Collaborators
Bial - Portela C S.A.
Investigators
Principal Investigator: Manuel Vaz-da-Silva, MD, PhD BIAL - Portela & Cª S.A.
  More Information

No publications provided

Responsible Party: Bial - Portela C S.A.
ClinicalTrials.gov Identifier: NCT01679002     History of Changes
Other Study ID Numbers: BIA-2093-110
Study First Received: August 31, 2012
Results First Received: November 28, 2014
Last Updated: December 31, 2014
Health Authority: Portugal: National Pharmacy and Medicines Institute

Keywords provided by Bial - Portela C S.A.:
Epilepsy
Oxcarbazepine
Eslicarbazepine Acetate
BIA 2-093

Additional relevant MeSH terms:
Carbamazepine
Eslicarbazepine acetate
Oxcarbazepine
Analgesics
Analgesics, Non-Narcotic
Anticonvulsants
Antimanic Agents
Cardiovascular Agents
Central Nervous System Agents
Central Nervous System Depressants
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Sensory System Agents
Sodium Channel Blockers
Therapeutic Uses
Tranquilizing Agents
Voltage-Gated Sodium Channel Blockers

ClinicalTrials.gov processed this record on April 19, 2015