Back to results

Disposition of Eslicarbazepine Acetate and Its Metabolites S-licarbazepine and R-licarbazepine

Primary Purpose

Epilepsy

Status

Completed

Phase

Phase 1

Locations

Germany

Study Type

Interventional

Intervention

BIA 2-093

S-licarbazepine

R-licarbazepine

About this trial

This is an interventional treatment trial for Epilepsy

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria

Male or female 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 clinically acceptable 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 who smoke < 10 cigarettes or equivalent per day.
Subjects who are able and willing to give written informed consent.
(If female) She was not of childbearing potential by reason of surgery or, if of childbearing potential, she used one of the following methods of contraception: double barrier, intrauterine device or abstinence.
(If female) She had a negative pregnancy test at screening and admission to Phase A.

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 (especially carbamazepine or oxcarbazepine).
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.

Sites / Locations

Scope International Life Sciences AG,

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Arm Label

eslicarbazepine acetate

S-licarbazepine R-licarbazepine

S-licarbazepine

R-licarbazepine

Arm Description

900mg of eslicarbazepine acetate (ESL, BIA 2-093)

450 mg of S-licarbazepine plus 450 mg of R-licarbazepine

450 mg of S-licarbazepine

450 mg of Rlicarbazepine

Outcomes

Primary Outcome Measures

Cmax - the Maximum Plasma Concentration

Tmax - the Time of Occurrence of Cmax

AUC0-∞ - the Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity

Secondary Outcome Measures

AUC0-t - the Area Under the Plasma Concentration-time Curve to Last Measurable Time Point

Full Information

NCT ID

NCT02281591

First Posted

October 30, 2014

Last Updated

November 28, 2014

Sponsor

Bial - Portela C S.A.

1. Study Identification

Unique Protocol Identification Number

NCT02281591

Brief Title

Disposition of Eslicarbazepine Acetate and Its Metabolites S-licarbazepine and R-licarbazepine

Official Title

Disposition of Eslicarbazepine Acetate and Its Metabolites S-licarbazepine and R-licarbazepine Following Oral Administration in Healthy Volunteers

Study Type

Interventional

2. Study Status

Record Verification Date

November 2014

Overall Recruitment Status

Completed

Study Start Date

June 2006 (undefined)

Primary Completion Date

July 2006 (Actual)

Study Completion Date

July 2006 (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, open-label, randomised study in four parallel groups of healthy volunteers

Detailed Description

Single centre, open-label, randomised study in four parallel groups of healthy volunteers: Group 1 = 900 mg of eslicarbazepine acetate (ESL, BIA 2-093); Group 2 = 450 mg of S-licarbazepine plus 450 mg of R-licarbazepine; Group 3 = 450 mg of S-licarbazepine; Group 4 = 450 mg of Rlicarbazepine. In each group, the study consisted of a single-dose period (Phase A) followed by a repeateddose period of 7 days of duration in which the investigational product was administered once daily (Phase B). The repeated-dose phase started 96 h post single-dose.

6. Conditions and Keywords

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

Epilepsy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

32 (Actual)

8. Arms, Groups, and Interventions

Arm Title

eslicarbazepine acetate

Arm Type

Experimental

Arm Description

900mg of eslicarbazepine acetate (ESL, BIA 2-093)

Arm Title

S-licarbazepine R-licarbazepine

Arm Type

Active Comparator

Arm Description

450 mg of S-licarbazepine plus 450 mg of R-licarbazepine

Arm Title

S-licarbazepine

Arm Type

Active Comparator

Arm Description

450 mg of S-licarbazepine

Arm Title

R-licarbazepine

Arm Type

Active Comparator

Arm Description

450 mg of Rlicarbazepine

Intervention Type

Drug

Intervention Name(s)

BIA 2-093

Intervention Description

Tablets containing 900 mg

Intervention Type

Drug

Intervention Name(s)

S-licarbazepine

Intervention Description

capsules containing 225 mg

Intervention Type

Drug

Intervention Name(s)

R-licarbazepine

Intervention Description

capsules containing 225 mg

Primary Outcome Measure Information:

Title

Cmax - the Maximum Plasma Concentration

Time Frame

Phase A: pre-dose (Day 1); and ½, 1, 1½, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose.Phase B: Days 6 to 10 inclusively: pre-dose. Day 11 (last dose): pre-dose; and ½, 1, 1½,2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose.

Title

Tmax - the Time of Occurrence of Cmax

Time Frame

Title

AUC0-∞ - the Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity

Time Frame

Secondary Outcome Measure Information:

Title

AUC0-t - the Area Under the Plasma Concentration-time Curve to Last Measurable Time Point

Time Frame

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria Male or female 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 clinically acceptable 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 who smoke < 10 cigarettes or equivalent per day. Subjects who are able and willing to give written informed consent. (If female) She was not of childbearing potential by reason of surgery or, if of childbearing potential, she used one of the following methods of contraception: double barrier, intrauterine device or abstinence. (If female) She had a negative pregnancy test at screening and admission to Phase A. 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 (especially carbamazepine or oxcarbazepine). 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.

Facility Information:

Facility Name

Scope International Life Sciences AG,

City

Hamburg

ZIP/Postal Code

D-22525

Country

Germany

12. IPD Sharing Statement

Learn more about this trial

Disposition of Eslicarbazepine Acetate and Its Metabolites S-licarbazepine and R-licarbazepine

We'll reach out to this number within 24 hrs