Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.

A Double-blind, Randomised, Placebo-controlled, Rising Multiple Dose Study to Investigate the Safety, Tolerability, Steady State Pharmacokinetic Profile and CNS Effects of BIA 2-093

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: NCT02171234
Recruitment Status : Completed
First Posted : June 24, 2014
Results First Posted : January 7, 2015
Last Update Posted : January 7, 2015
Sponsor:
Information provided by (Responsible Party):
Bial - Portela C S.A.

Brief Summary:
The purpose of this study is to investigate the safety and tolerability of multiple dose regimens of BIA 2-093 in healthy young male volunteers

Condition or disease Intervention/treatment Phase
Epilepsy Drug: Placebo Drug: BIA 2-093 Phase 1

Detailed Description:
Single centre, Phase I, double-blind, randomised, placebo-controlled study investigating 4 multiple rising oral doses of BIA 2-093 in 4 groups of 8 young healthy male subjects. Within each group, 2 subjects were randomised to receive placebo and the remaining 6 subjects to receive BIA 2-093. No subject was a member of more than one group. The dose regimens investigated were: 200 mg b.i.d.(twice daily), 400 mg o.d.(once daily; this was changed from 400 mg b.i.d. in protocol amendment 1, on the basis of interim pharmacokinetic analysis of Group 1 data), 800 mg o.d, and 1200 mg o.d. BIA 2-093/placebo was administered orally once daily on Days 1-8, or twice a day (at 12-hour intervals) on Days 1-7 with a final dose in the morning of Day 8. The multiple dose regimens were to be investigated in ascending order. Progression to each higher dose level was only to occur if the previous dose level was deemed by the investigator and the sponsor to be safe and well tolerated.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-blind, Randomised, Placebo-controlled, Rising Multiple Dose Study to Investigate the Safety, Tolerability, Steady State Pharmacokinetic Profile and CNS Effects of BIA 2-093, in Young Healthy Male Volunteers.
Study Start Date : February 2001
Actual Primary Completion Date : June 2001
Actual Study Completion Date : June 2001

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy

Arm Intervention/treatment
Experimental: Group 1- 200 mg b.i.d. (twice daily)
BIA 2-093 200mg with 200 ml potable water. Identical placebo administered as oral tablets.
Drug: Placebo
Other Name: PLC, Placebo

Drug: BIA 2-093
Other Name: ESL, Eslicarbazepine acetate

Experimental: Group 2 - 400 mg b.i.d.
BIA 2-093 200mg with 200 ml potable water. Identical placebo administered as oral tablets.
Drug: Placebo
Other Name: PLC, Placebo

Drug: BIA 2-093
Other Name: ESL, Eslicarbazepine acetate

Experimental: Group 3- 800 mg o.d. (once daily)
BIA 2-093 200mg with 200 ml potable water. Identical placebo administered as oral tablets.
Drug: Placebo
Other Name: PLC, Placebo

Drug: BIA 2-093
Other Name: ESL, Eslicarbazepine acetate

Experimental: Group 4 - either 800 mg b.i.d or 1200 mg o.d.
BIA 2-093 200mg with 200 ml potable water. Identical placebo administered as oral tablets.
Drug: Placebo
Other Name: PLC, Placebo

Drug: BIA 2-093
Other Name: ESL, Eslicarbazepine acetate




Primary Outcome Measures :
  1. Total Number of Adverse Events [ Time Frame: up to 20 weeks ]
    Total Number of Adverse Events.


Secondary Outcome Measures :
  1. Cmax [ Time Frame: Day 1 and Day 8 ]
    Cmax - Maximum observed plasma concentration

  2. AUC0-τ [ Time Frame: Day 1 - pre-dose, 30, 60, 90, 120, 180 minutes, 4, 6, 7, 8, 12, hours post final dose Day 8 - pre-dose, 30, 60, 90, 120, 180 minutes, 4, 6, 7, 8, 12, 24, 36, 48 and 72 hours post final dose ]

    AUC0-τ - Area under the plasma concentration time curve to last measurable time point

    Day 1 - pre-dose, 30, 60, 90, 120, 180 minutes, 4, 6, 7, 8, 12, hours post final dose Day 8 - pre-dose, 30, 60, 90, 120, 180 minutes, 4, 6, 7, 8, 12, 24, 36, 48 and 72 hours post final dose




Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria
  • Inclusion Criteria:
  • Adult males aged 18-45 years, with a body mass index (BMI) of 19-28 kg/m2.
  • Subjects who were healthy as determined by pre-study medical history, physical examination, 12-lead ECG and EEG.
  • Subjects who had clinical laboratory tests acceptable to the investigator.
  • Subjects who were negative for HbsAg, anti-HCV and HIV I and II tests at screening.
  • Subjects who were negative for drugs of abuse and alcohol tests at screening and admission.
  • Subjects who were non-smokers or previous smokers who had not smoked for at least 6 months.
  • Subjects who were able and willing to give written informed consent.
  • 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, 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 (carbamazepine and
  • related compounds).
  • Subjects who had a history of alcoholism.
  • Subjects who had a history of drug abuse.
  • Subjects who consumed more than 28 units of alcohol a week.
  • Subjects who had a significant infection or known inflammatory process on screening and/or admission.
  • Subjects who had acute gastrointestinal symptoms at the time of screening and/or admission (e.g. nausea, vomiting, diarrhoea, heartburn).
  • Subjects who had an acute infection such as influenza at the time of screening and/or admission.
  • Subjects who had used prescription drugs within 4 weeks of first dosing.
  • Subjects who had used over the counter medication, excluding routine vitamins but including mega dose vitamin therapy, within one week of dosing.
  • Subjects who had used any investigational drug and/or participated in any clinical trial within 3 months of admission to this study.
  • Subjects who had donated and/or received any blood or blood products within 3 months prior to screening.
  • Subjects who were vegetarians, vegans and/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.
  • Subjects who were unwilling or unable to give written informed consent.
  • Subjects who had previously received BIA 2-093.

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): NCT02171234


Locations
Layout table for location information
United Kingdom
Guy's Drug Research Unit
London, United Kingdom, SE1 1YR
Sponsors and Collaborators
Bial - Portela C S.A.

Layout table for additonal information
Responsible Party: Bial - Portela C S.A.
ClinicalTrials.gov Identifier: NCT02171234    
Other Study ID Numbers: BIA-2093-102
First Posted: June 24, 2014    Key Record Dates
Results First Posted: January 7, 2015
Last Update Posted: January 7, 2015
Last Verified: December 2014
Keywords provided by Bial - Portela C S.A.:
Epilepsy
BIA 2-093
Eslicarbazepine acetate
Additional relevant MeSH terms:
Layout table for MeSH terms
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