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A Study to Evaluate the Tolerability and Pharmacokinetics of Two Single and Multiple High Dose Regimens of BIA 2-093 In Healthy Volunteers

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: NCT01879345
Recruitment Status : Completed
First Posted : June 17, 2013
Results First Posted : December 30, 2014
Last Update Posted : December 30, 2014
Sponsor:
Information provided by (Responsible Party):
Bial - Portela C S.A.

Brief Summary:
Single centre, double-blind, randomised, placebo-controlled study of two dosage regimens of BIA 2-093 - 1800 mg (Group 1) and 2400 mg (Group 2) - in two groups of healthy male volunteers

Condition or disease Intervention/treatment Phase
Epilepsy Drug: BIA 2-093 - 1800 mg (Group 1) Drug: BIA 2-093 - 2400 mg (Group 2) Drug: Placebo Phase 1

Detailed Description:

Within each group (n=9) 3 volunteers were randomised to receive placebo and the remaining 6 volunteers to receive BIA 2-093. No volunteer was a member of more than one treatment group. In each group, the study consisted of a single-dose period (Phase A) followed by a 7-day multiple-dose period (Phase B). The multiple-dose phase started 96 h post single-dose. Progression to the 2400 mg dose (Group 2) only occurred if the 1800 mg dose (Group 1) was considered to be safe and well tolerated. An appropriate interval separated the investigation of the two groups in order to permit a timely review and evaluation of safety data.

Treatment consisted of a single-dose (Phase A) followed by a once-daily dose for 7 days (Phase B). Doses were prepared as follows: Group 1 = 3 tablets of BIA 2-093 600 mg plus 1 placebo tablet, or 4 placebo tablets; Group 2 = 4 tablets of BIA 2-093 600 mg, or 4 placebo tablets.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A DOUBLE-BLIND, RANDOMISED, PLACEBO-CONTROLLED STUDY TO EVALUATE THE TOLERABILITY AND PHARMACOKINETICS OF TWO SINGLE AND MULTIPLE HIGH DOSE REGIMENS OF BIA 2-093 IN HEALTHY VOLUNTEERS
Study Start Date : October 2004
Actual Primary Completion Date : December 2004
Actual Study Completion Date : December 2004

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: BIA 2-093 - 1800 mg (Group 1)
3 tablets of BIA 2-093 600 mg
Drug: BIA 2-093 - 1800 mg (Group 1)
3 tablets of BIA 2-093
Other Name: Eslicarbazepine acetate

Experimental: BIA 2-093 - 2400 mg (Group 2)
4 tablets of BIA 2-093 600 mg
Drug: BIA 2-093 - 2400 mg (Group 2)
4 tablets of BIA 2-093 600 mg
Other Name: Eslicarbazepine acetate

Placebo Comparator: Placebo
placebo tablets
Drug: Placebo
placebo tablets
Other Name: sugar pills




Primary Outcome Measures :
  1. Number of Adverse Events Reported [ Time Frame: 3 weeks ]
    investigate the tolerability of two single- and multiple-dose regimens of BIA 2-093 (1800 mg and 2400 mg)considering the Number of adverse events reported by patient


Secondary Outcome Measures :
  1. Cmax - Maximum Observed Plasma Drug Concentration [ Time Frame: Day 1 and Day 7 ]

    Single dose: pharmacokinetic parameters following an oral single-dose of BIA 2-093 Multiple dose: pharmacokinetic parameters following the last dose of an oral 7- day once-daily regimen of BIA 2-093

    Oxcarbazepine is a BIA 2-093 metabolite


  2. Tmax - the Time of Occurrence of Cmax [ Time Frame: Day 1 and Day 7 ]
    Single dose: pharmacokinetic parameters following an oral single-dose of BIA 2-093 Multiple dose: pharmacokinetic parameters following the last dose of an oral 7- day once-daily regimen of BIA 2-093

  3. AUC0-τ [ Time Frame: Day 1 and Day 7 ]
    Single dose: pharmacokinetic parameters following an oral single-dose of BIA 2-093 Multiple dose: pharmacokinetic parameters following the last dose of an oral 7- day once-daily regimen of BIA 2-093



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male subjects aged between 18 and 45 years, inclusive.
  • Subjects of body mass index (BMI) between 19 and 30 kg/m2, inclusive.
  • Subjects who were healthy as determined by pre-study medical history, physical examination, vital signs, neurological examination, and 12-lead ECG.
  • Subjects who had clinical laboratory tests within normal ranges at screening and admission.
  • Subjects who had negative tests for HBsAg, anti-HCV Ab and HIV-1 and HIV-2 Ab at screening.
  • Subjects who were negative for drugs of abuse and alcohol at screening and admission.
  • Subjects who were non-smokers or smoked less than 10 cigarettes or equivalent per day.
  • Subjects who were able and willing to give written informed consent.

Exclusion Criteria:

  • Subjects who did not conform to the above inclusion criteria, OR
  • 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 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 or admission.
  • Subjects who had acute gastrointestinal symptoms at the time of screening or admission (e.g., nausea, vomiting, diarrhoea, heartburn).
  • Subjects who had used prescription or over-the-counter medication within 2 weeks of admission.
  • Subjects who had used any investigational drug or participated in any clinical trial within 3 months of admission.
  • Subjects who had previously received BIA 2-093.
  • Subjects who had donated or received any blood or blood products within the previous 3 months prior to screening.
  • Subjects who were vegetarians, vegans or had 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01879345


Locations
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Portugal
Human Pharmacology Unit - BIAL - Portela & Ca, S.A.
S. Mamede do Coronado, Portugal, 4745-457
Sponsors and Collaborators
Bial - Portela C S.A.

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Responsible Party: Bial - Portela C S.A.
ClinicalTrials.gov Identifier: NCT01879345    
Other Study ID Numbers: BIA-2093-113
First Posted: June 17, 2013    Key Record Dates
Results First Posted: December 30, 2014
Last Update Posted: December 30, 2014
Last Verified: December 2014
Keywords provided by Bial - Portela C S.A.:
Anticonvulsant
Additional relevant MeSH terms:
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Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Eslicarbazepine acetate
Anticonvulsants
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action