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: NA
Last verified: August 2012
History: No changes posted
  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:
  • maximum observed plasma drug concentration (Cmax) [ 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 ]
    Pharmacokinetic parameters were derived from the concentration versus time profiles after each dose in each subject:time at which the Cmax occurred (tmax)


Secondary Outcome Measures:
  • area under the plasma concentration versus time curve (AUC) [ 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 ]
    Pharmacokinetic parameters were derived from the concentration versus time profiles after each dose in each subject: area under the plasma concentration versus time curve (AUC) to last measurable time point (AUC0-t)


Other Outcome Measures:
  • Number of adverse events reported per patient [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
    Monitoring of Adverse Events throughout the study: Safety was evaluated from the number of reported adverse events (AEs) by patient


Enrollment: 11
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: BIA 2-093
According to randomisation, subjects were to receive BIA 2-093 450 mg bid, BIA 2-093 900 mg od, or Trileptal® 450 mg bid on each of the 3 periods
Drug: BIA 2-093
Tablets containing BIA 2-093 450 mg
Other Name: Eslicarbazepine acetate
Active Comparator: Oxcarbazepine
According to randomisation, subjects were to receive BIA 2-093 450 mg bid, BIA 2-093 900 mg od, or Trileptal® 450 mg bid on each of the 3 periods
Drug: Oxcarbazepine
Trileptal® tablets containing 150 mg and 300 mg of Oxcarbazepine
Other Name: 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
Last Updated: August 31, 2012
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:
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Eslicarbazepine acetate
Oxcarbazepine
Carbamazepine
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Anticonvulsants
Central Nervous System Agents
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on September 18, 2014