Back to results

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

Primary Purpose

Epilepsy

Status

Completed

Phase

Phase 1

Locations

Portugal

Study Type

Interventional

Intervention

BIA 2-093 - 1800 mg (Group 1)

BIA 2-093 - 2400 mg (Group 2)

Placebo

About this trial

This is an interventional treatment trial for Epilepsy focused on measuring Anticonvulsant

Eligibility Criteria

18 Years - 45 Years (Adult)MaleAccepts Healthy Volunteers

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.

Sites / Locations

Human Pharmacology Unit - BIAL - Portela & Ca, S.A.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

BIA 2-093 - 1800 mg (Group 1)

BIA 2-093 - 2400 mg (Group 2)

Placebo

Arm Description

3 tablets of BIA 2-093 600 mg

4 tablets of BIA 2-093 600 mg

placebo tablets

Outcomes

Primary Outcome Measures

Number of Adverse Events Reported

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

Cmax - Maximum Observed Plasma Drug Concentration

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

Tmax - the Time of Occurrence of Cmax

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

AUC0-τ

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

Full Information

NCT ID

NCT01879345

First Posted

June 13, 2013

Last Updated

December 17, 2014

Sponsor

Bial - Portela C S.A.

1. Study Identification

Unique Protocol Identification Number

NCT01879345

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

December 2014

Overall Recruitment Status

Completed

Study Start Date

October 2004 (undefined)

Primary Completion Date

December 2004 (Actual)

Study Completion Date

December 2004 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Bial - Portela C S.A.

4. Oversight

Data Monitoring Committee

5. Study Description

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Epilepsy

Keywords

Anticonvulsant

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

18 (Actual)

8. Arms, Groups, and Interventions

Arm Title

BIA 2-093 - 1800 mg (Group 1)

Arm Type

Experimental

Arm Description

3 tablets of BIA 2-093 600 mg

Arm Title

BIA 2-093 - 2400 mg (Group 2)

Arm Type

Experimental

Arm Description

4 tablets of BIA 2-093 600 mg

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

placebo tablets

Intervention Type

Drug

Intervention Name(s)

BIA 2-093 - 1800 mg (Group 1)

Other Intervention Name(s)

Eslicarbazepine acetate

Intervention Description

3 tablets of BIA 2-093

Intervention Type

Drug

Intervention Name(s)

BIA 2-093 - 2400 mg (Group 2)

Other Intervention Name(s)

Eslicarbazepine acetate

Intervention Description

4 tablets of BIA 2-093 600 mg

Intervention Type

Drug

Intervention Name(s)

Placebo

Other Intervention Name(s)

sugar pills

Intervention Description

placebo tablets

Primary Outcome Measure Information:

Title

Number of Adverse Events Reported

Description

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

Time Frame

3 weeks

Secondary Outcome Measure Information:

Title

Cmax - Maximum Observed Plasma Drug Concentration

Description

Time Frame

Day 1 and Day 7

Title

Tmax - the Time of Occurrence of Cmax

Description

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

Time Frame

Day 1 and Day 7

Title

AUC0-τ

Description

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

Time Frame

Day 1 and Day 7

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility 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.

Facility Information:

Facility Name

Human Pharmacology Unit - BIAL - Portela & Ca, S.A.

City

S. Mamede do Coronado

ZIP/Postal Code

4745-457

Country

Portugal

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs