Back to resultsA Single Centre, Phase I, Double-blind, Randomised, Placebo-controlled Study to Investigate the Safety, Tolerability, Pharmacokinetic Profile and Effects on EEG of Single Rising Oral Doses of BIA 2-093
Primary Purpose
Epilepsy
Status
Completed
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
BIA 2-093
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Epilepsy focused on measuring Eslicarbazepine acetate, BIA 2-093, Epilepsy
Eligibility Criteria
Inclusion Criteria:
Adult males aged 18-35 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 who 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.
- 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 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.
Sites / Locations
- Guy's Drug Research Unit
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Arm Label
Group 1 (20 mg)
Group 2 (50 mg)
Group 3 (100 mg)
Group 4 (200 mg)
Group 5 (400 mg)
Group 6 (600 mg)
Group 7 (900 mg)
Group 8 (1200 mg)
Arm Description
Outcomes
Primary Outcome Measures
Total Number of Adverse Events
An adverse event was defined as any undesirable event occurring to a subject during the study, whether or not related to the investigational product
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02171195
Brief Title
A Single Centre, Phase I, Double-blind, Randomised, Placebo-controlled Study to Investigate the Safety, Tolerability, Pharmacokinetic Profile and Effects on EEG of Single Rising Oral Doses of BIA 2-093
Official Title
A Single Centre, Phase I, Double-blind, Randomised, Placebo-controlled Study to Investigate the Safety, Tolerability, Pharmacokinetic Profile and Effects on EEG of Single Rising Oral Doses of BIA 2-093 When Given to Healthy Male Adult Volunteers.
Study Type
Interventional
2. Study Status
Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
July 2000 (undefined)
Primary Completion Date
October 2000 (Actual)
Study Completion Date
October 2000 (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 determine the safety and tolerability of single rising oral doses of BIA 2-093 (proposed doses 20mg, 50mg, 100mg, 200mg, 400mg, 600mg, 900mg and 1200mg) in groups of 8 healthy male adult volunteers.
Detailed Description
Single centre, Phase I, double-blind, randomised, placebo-controlled study to investigate single rising oral doses of BIA 2-093 up to 1200 mg in sequential groups of eight healthy male adult subjects. Within each group of eight subjects two subjects were randomised to receive placebo and the remaining six subjects were randomised to receive BIA 2-093. No subject was a member of more than one treatment group. Doses of 20mg, 50mg, 100mg, 200mg, 400mg, 600mg, 900mg and 1200mg were investigated in ascending order. Progression to each dose occurred only after the previous dose level was deemed to be safe and well tolerated by the investigator and the sponsor.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy
Keywords
Eslicarbazepine acetate, BIA 2-093, Epilepsy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
64 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group 1 (20 mg)
Arm Type
Experimental
Arm Title
Group 2 (50 mg)
Arm Type
Experimental
Arm Title
Group 3 (100 mg)
Arm Type
Experimental
Arm Title
Group 4 (200 mg)
Arm Type
Experimental
Arm Title
Group 5 (400 mg)
Arm Type
Experimental
Arm Title
Group 6 (600 mg)
Arm Type
Experimental
Arm Title
Group 7 (900 mg)
Arm Type
Experimental
Arm Title
Group 8 (1200 mg)
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
BIA 2-093
Other Intervention Name(s)
ESL, Eslicarbazepine acetate
Intervention Description
BIA 2-093 20mg, 50 mg, 100 mg, 200 mg, 400 mg, 600 mg, 900 mg, 1200 mg
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
PLC
Intervention Description
Identical placebo administered as oral tablets with 200 ml potable water.
Primary Outcome Measure Information:
Title
Total Number of Adverse Events
Description
An adverse event was defined as any undesirable event occurring to a subject during the study, whether or not related to the investigational product
Time Frame
up to 20 weeks
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Adult males aged 18-35 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 who 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.
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 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.
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 Single Centre, Phase I, Double-blind, Randomised, Placebo-controlled Study to Investigate the Safety, Tolerability, Pharmacokinetic Profile and Effects on EEG of Single Rising Oral Doses of BIA 2-093
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