Back to resultsA 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
Primary Purpose
Epilepsy
Status
Completed
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
Placebo
BIA 2-093
Sponsored by
About this trial
This is an interventional treatment trial for Epilepsy focused on measuring Epilepsy, BIA 2-093, Eslicarbazepine acetate
Eligibility 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.
Sites / Locations
- Guy's Drug Research Unit
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
Group 1- 200 mg b.i.d. (twice daily)
Group 2 - 400 mg b.i.d.
Group 3- 800 mg o.d. (once daily)
Group 4 - either 800 mg b.i.d or 1200 mg o.d.
Arm Description
BIA 2-093 200mg with 200 ml potable water. Identical placebo administered as oral tablets.
BIA 2-093 200mg with 200 ml potable water. Identical placebo administered as oral tablets.
BIA 2-093 200mg with 200 ml potable water. Identical placebo administered as oral tablets.
BIA 2-093 200mg with 200 ml potable water. Identical placebo administered as oral tablets.
Outcomes
Primary Outcome Measures
Total Number of Adverse Events
Total Number of Adverse Events.
Secondary Outcome Measures
Cmax
Cmax - Maximum observed plasma concentration
AUC0-τ
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02171234
Brief 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
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 Type
Interventional
2. Study Status
Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
February 2001 (undefined)
Primary Completion Date
June 2001 (Actual)
Study Completion Date
June 2001 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bial - Portela C S.A.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy
Keywords
Epilepsy, BIA 2-093, Eslicarbazepine acetate
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group 1- 200 mg b.i.d. (twice daily)
Arm Type
Experimental
Arm Description
BIA 2-093 200mg with 200 ml potable water. Identical placebo administered as oral tablets.
Arm Title
Group 2 - 400 mg b.i.d.
Arm Type
Experimental
Arm Description
BIA 2-093 200mg with 200 ml potable water. Identical placebo administered as oral tablets.
Arm Title
Group 3- 800 mg o.d. (once daily)
Arm Type
Experimental
Arm Description
BIA 2-093 200mg with 200 ml potable water. Identical placebo administered as oral tablets.
Arm Title
Group 4 - either 800 mg b.i.d or 1200 mg o.d.
Arm Type
Experimental
Arm Description
BIA 2-093 200mg with 200 ml potable water. Identical placebo administered as oral tablets.
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
PLC, Placebo
Intervention Type
Drug
Intervention Name(s)
BIA 2-093
Other Intervention Name(s)
ESL, Eslicarbazepine acetate
Primary Outcome Measure Information:
Title
Total Number of Adverse Events
Description
Total Number of Adverse Events.
Time Frame
up to 20 weeks
Secondary Outcome Measure Information:
Title
Cmax
Description
Cmax - Maximum observed plasma concentration
Time Frame
Day 1 and Day 8
Title
AUC0-τ
Description
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
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
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Facility Information:
Facility Name
Guy's Drug Research Unit
City
London
ZIP/Postal Code
SE1 1YR
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
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
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