Back to resultsSingle-dose and Steady-state Pharmacokinetics of BIA 2-093 and Its Metabolites
Primary Purpose
Epilepsy
Status
Completed
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
BIA 2-093
Sponsored by
About this trial
This is an interventional treatment trial for Epilepsy focused on measuring Eslicarbazepine acetate, BIA 2-093
Eligibility Criteria
Inclusion Criteria:
- Male or female subjects aged between 18 and 40 years, inclusive OR male or female subjects aged 65 years or more.
- If young, subjects who were within 15% of ideal body weight OR, if elderly, subjects who were within 20% of ideal body weight according to the Metropolitan Life Insurance Table.
- 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 acceptable to the Investigator.
- Subjects who were negative for HBsAg, HCVAb and HIV-1 and HIV-2 Ab tests at screening.
- Subjects who were negative for alcohol and drugs of abuse at screening.
- 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 female) She was not of childbearing potential by reason of surgery or menopause or, if of childbearing potential, she used one of the following methods of contraception: double barrier or intrauterine.
- (If female and with less than 40 years old) She had a negative pregnancy test at screening.
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.
- 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 admission.
- Subjects who had acute gastrointestinal symptoms at the time of screening and/or admission (e.g., nausea, vomiting, diarrhoea, heartburn).
- Subjects who had used drugs within 2 weeks of first dosing.
- Subjects who had used any investigational drug and/or participated in any clinical trial within 3 months of their first admission to this study.
- Subjects who had previously received BIA 2-093.
- Subjects who had donated and/or received any blood or blood products within the previous 2 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.
- (If female) She was pregnant or breast-feeding
- (If female) She was of childbearing potential and she did not use an authorised effective contraceptive method.
Sites / Locations
- Scope International Life Sciences AG,
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Elderly subjects
Young subjects
Arm Description
14 Elderly subjects aged 65 years or more; During the whole study, subjects were to receive a single 600 mg dose of BIA 2-093 (Phase A) followed by 600 mg BIA 2-093 once daily for 8 days in Phase B. Phase B was to begun 96 hours post-Phase A dose.
16 young subjects aged between 18 and 40 years During the whole study, subjects were to receive a single 600 mg dose of BIA 2-093 (Phase A) followed by 600 mg BIA 2-093 once daily for 8 days in Phase B. Phase B was to begun 96 hours post-Phase A dose.
Outcomes
Primary Outcome Measures
Maximum Drug Concentration (Cmax)
Single-dose period: Day 1 at pre-dose, and ½, 1, 1½, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours post-dose.
Multiple-dose period: from Day 5 to Day 11 inclusive, early in the morning, before the daily dose (for trough levels).
Day 12: pre-dose, and ½, 1, 1½, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 120 hours post-last dose.
BIA 2-194, BIA 2-195, and oxcarbazepine are metabolites of BIA 2-093
Secondary Outcome Measures
Tmax - Time of Maximum Observed Concentration
Single-dose period: Day 1 at pre-dose, and ½, 1, 1½, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours post-dose.
Multiple-dose period: from Day 5 to Day 11 inclusive, early in the morning, before the daily dose (for trough levels).
Day 12: pre-dose, and ½, 1, 1½, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 120 hours post-last dose.
BIA 2-194, BIA 2-195, and oxcarbazepine are metabolites of BIA 2-093
AUC0-t - Area Under the Plasma Concentration-time Curve to Last Measurable Time Point
Single-dose period: Day 1 at pre-dose, and ½, 1, 1½, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours post-dose.
Multiple-dose period: from Day 5 to Day 11 inclusive, early in the morning, before the daily dose (for trough levels).
Day 12: pre-dose, and ½, 1, 1½, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 120 hours post-last dose.
BIA 2-194, BIA 2-195, and oxcarbazepine are metabolites of BIA 2-093
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02172755
Brief Title
Single-dose and Steady-state Pharmacokinetics of BIA 2-093 and Its Metabolites
Official Title
Single-dose and Steady-state Pharmacokinetics of BIA 2-093 and Its Metabolites in Healthy Elderly Subjects Compared With Those in Healthy Young Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
June 2002 (undefined)
Primary Completion Date
August 2002 (Actual)
Study Completion Date
August 2002 (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 effects of age on the pharmacokinetic profile of BIA 2-093 and its active metabolites.
Detailed Description
This was a single-centre, open-label, parallel group, non-randomised study with a single-dose phase (Phase A) followed by a multiple-dose phase (Phase B), in 12 healthy elderly and 12 healthy young subjects. During the whole study, subjects were to receive a single 600 mg dose of BIA 2-093 (Phase A) followed by 600 mg BIA 2-093 once daily for 8 days in Phase B. Phase B was to begun 96 hours post-Phase A dose.
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Elderly subjects
Arm Type
Experimental
Arm Description
14 Elderly subjects aged 65 years or more; During the whole study, subjects were to receive a single 600 mg dose of BIA 2-093 (Phase A) followed by 600 mg BIA 2-093 once daily for 8 days in Phase B. Phase B was to begun 96 hours post-Phase A dose.
Arm Title
Young subjects
Arm Type
Experimental
Arm Description
16 young subjects aged between 18 and 40 years During the whole study, subjects were to receive a single 600 mg dose of BIA 2-093 (Phase A) followed by 600 mg BIA 2-093 once daily for 8 days in Phase B. Phase B was to begun 96 hours post-Phase A dose.
Intervention Type
Drug
Intervention Name(s)
BIA 2-093
Other Intervention Name(s)
Eslicarbazepine acetate
Intervention Description
During the whole study, subjects were to receive a single 600 mg dose of BIA 2-093 (Phase A) followed by 600 mg BIA 2-093 once daily for 8 days in Phase B. Phase B was to begun 96 hours post-Phase A dose.
Primary Outcome Measure Information:
Title
Maximum Drug Concentration (Cmax)
Description
Single-dose period: Day 1 at pre-dose, and ½, 1, 1½, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours post-dose.
Multiple-dose period: from Day 5 to Day 11 inclusive, early in the morning, before the daily dose (for trough levels).
Day 12: pre-dose, and ½, 1, 1½, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 120 hours post-last dose.
BIA 2-194, BIA 2-195, and oxcarbazepine are metabolites of BIA 2-093
Time Frame
Day 1 at pre-dose, and ½, 1, 1½, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours post-dose From Day 5 to Day 11 inclusive, before the daily dose (for trough levels). On Day 12, pre-dose, and ½, 1, 1½, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 120 hours p
Secondary Outcome Measure Information:
Title
Tmax - Time of Maximum Observed Concentration
Description
Single-dose period: Day 1 at pre-dose, and ½, 1, 1½, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours post-dose.
Multiple-dose period: from Day 5 to Day 11 inclusive, early in the morning, before the daily dose (for trough levels).
Day 12: pre-dose, and ½, 1, 1½, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 120 hours post-last dose.
BIA 2-194, BIA 2-195, and oxcarbazepine are metabolites of BIA 2-093
Time Frame
Day 1 at pre-dose, and ½, 1, 1½, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours post-dose From Day 5 to Day 11 inclusive, before the daily dose (for trough levels). On Day 12, pre-dose, and ½, 1, 1½, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 120 hours p
Title
AUC0-t - Area Under the Plasma Concentration-time Curve to Last Measurable Time Point
Description
Single-dose period: Day 1 at pre-dose, and ½, 1, 1½, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours post-dose.
Multiple-dose period: from Day 5 to Day 11 inclusive, early in the morning, before the daily dose (for trough levels).
Day 12: pre-dose, and ½, 1, 1½, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 120 hours post-last dose.
BIA 2-194, BIA 2-195, and oxcarbazepine are metabolites of BIA 2-093
Time Frame
Day 1 at pre-dose, and ½, 1, 1½, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours post-dose From Day 5 to Day 11 inclusive, before the daily dose (for trough levels). On Day 12, pre-dose, and ½, 1, 1½, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 120 hours p
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Male or female subjects aged between 18 and 40 years, inclusive OR male or female subjects aged 65 years or more.
If young, subjects who were within 15% of ideal body weight OR, if elderly, subjects who were within 20% of ideal body weight according to the Metropolitan Life Insurance Table.
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 acceptable to the Investigator.
Subjects who were negative for HBsAg, HCVAb and HIV-1 and HIV-2 Ab tests at screening.
Subjects who were negative for alcohol and drugs of abuse at screening.
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 female) She was not of childbearing potential by reason of surgery or menopause or, if of childbearing potential, she used one of the following methods of contraception: double barrier or intrauterine.
(If female and with less than 40 years old) She had a negative pregnancy test at screening.
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.
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 admission.
Subjects who had acute gastrointestinal symptoms at the time of screening and/or admission (e.g., nausea, vomiting, diarrhoea, heartburn).
Subjects who had used drugs within 2 weeks of first dosing.
Subjects who had used any investigational drug and/or participated in any clinical trial within 3 months of their first admission to this study.
Subjects who had previously received BIA 2-093.
Subjects who had donated and/or received any blood or blood products within the previous 2 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.
(If female) She was pregnant or breast-feeding
(If female) She was of childbearing potential and she did not use an authorised effective contraceptive method.
Facility Information:
Facility Name
Scope International Life Sciences AG,
City
Hamburg
ZIP/Postal Code
D-22525
Country
Germany
12. IPD Sharing Statement
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Single-dose and Steady-state Pharmacokinetics of BIA 2-093 and Its Metabolites
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