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Effect of BIA 2-093 on the Pharmacokinetics of a Combined Oral Contraceptive.

Primary Purpose

Epilepsy

Status

Completed

Phase

Phase 1

Locations

Portugal

Study Type

Interventional

Intervention

BIA 2-093

Contraceptives, Oral, Combined

About this trial

This is an interventional treatment trial for Epilepsy

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Pre-menopausal female;
Able and willing to give written informed consent;
Aged 18 to 40 years, inclusive;
Not pregnant or breast-feeding;
Body mass index (BMI) between 19 and 30 kg/m2, inclusive;
Healthy as determined by medical history, physical examination, complete neurological examination, vital signs, and 12-lead ECG;
Clinical laboratory tests with clinically acceptable results at screening and admission to the first period;
Negative tests for HBsAg, anti-HCV Ab and HIV-1 and HIV-2 Ab at screening;
Negative test for drugs of abuse at screening;
Non-smoker or smokes less than 10 cigarettes or equivalent per day;
Agreed to either practice abstinence or use a double-barrier or intra-uterine device from screening until the follow-up visit;
Negative pregnancy test at screening and admission to the first period.

Exclusion Criteria:

Had any contra-indication to the use of oral contraceptives;
Had experienced notable adverse events while on any oral contraceptive;
Had a history of alcoholism or drug abuse;
Had a relevant history or presence of respiratory, gastrointestinal, renal, hepatic,haematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, endocrine, connective tissue diseases or disorders;
Had acute gastrointestinal symptoms at the time of screening or admission to the first period;
Had a significant infection or inflammatory process at the time of screening or admission to the first period;
Had a relevant surgical history;
Had a relevant family history;
Had a history of relevant drug hypersensitivity (e.g., carbamazepine or oxcarbazepine);
Had used relevant prescription or over-the-counter medication within 2 weeks ofadmission to the first period;
Consumed more than 14 units of alcohol a week;
Had participated in any clinical trial within 3 months prior to screening;
Had previously received BIA 2-093;
Had donated or received any blood or blood products within 2 months prior to screening;
Was unlikely to co-operate with the requirements of the study.

Sites / Locations

BIAL - Portela & Cª, S.A.

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Arm Label

Treatment sequence A

Treatment sequence B

Arm Description

oral once daily dose of 1200 mg of BIA 2-093 plus single-dose of a contraceptive for 15 days followed by washout and 3 days of oral single-dose contraceptive

oral single-dose of a contraceptive for 3 days after pre-treatment with an oral once daily dose of 1200 mg of BIA 2-093 plus single-dose of a contraceptive for 15 days

Outcomes

Primary Outcome Measures

Cmax - Maximum Observed Plasma BIA 2-194 Concentration

Cmax - Maximum observed plasma BIA 2-194 concentration on days 1, 2, 4, 6, 8, 10, 12, 14 and 15 during a 15-day oral regimen of BIA 2-093 1200 mg once-daily.

Secondary Outcome Measures

Cmax

Cmax following administration of a single-dose of Microginon® concomitantly with the 14th dose of a 15-day oral regimen of BIA 2-093 1200 mg once-daily (Test) and following administration of a single-dose of Microginon® administered alone (Reference)

Tmax

Tmax following administration of a single-dose of Microginon® concomitantly with the 14th dose of a 15-day oral regimen of BIA 2-093 1200 mg once-daily (Test) and following administration of a single-dose of Microginon® administered alone (Reference)

AUC0-t

AUC0-t (ng.h/mL) following administration of a single-dose of Microginon® concomitantly with the 14th dose of a 15-day oral regimen of BIA 2-093 1200 mg once-daily (Test) and following administration of a single-dose of Microginon® administered alone (Reference)

Full Information

NCT ID

NCT02281448

First Posted

October 30, 2014

Last Updated

November 28, 2014

Sponsor

Bial - Portela C S.A.

1. Study Identification

Unique Protocol Identification Number

NCT02281448

Brief Title

Effect of BIA 2-093 on the Pharmacokinetics of a Combined Oral Contraceptive.

Official Title

Effect of BIA 2-093 on the Pharmacokinetics of a Combined Oral Contraceptive in Healthy Female Volunteers

Study Type

Interventional

2. Study Status

Record Verification Date

November 2014

Overall Recruitment Status

Completed

Study Start Date

March 2005 (undefined)

Primary Completion Date

May 2005 (Actual)

Study Completion Date

May 2005 (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

Detailed Description

Single centre, two-way crossover, randomised, open-label study in 20 healthy female volunteers.The volunteers received an oral single-dose of a combined contraceptive containing 30 μg ethinyloestradiol and 150 μg levonorgestrel on two occasions - once as such and once after pre-treatment with an oral once daily dose of 1200 mg of BIA 2-093 for 15 days separated by a washout period of at least 3 weeks.

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

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Treatment sequence A

Arm Type

Other

Arm Description

oral once daily dose of 1200 mg of BIA 2-093 plus single-dose of a contraceptive for 15 days followed by washout and 3 days of oral single-dose contraceptive

Arm Title

Treatment sequence B

Arm Type

Other

Arm Description

oral single-dose of a contraceptive for 3 days after pre-treatment with an oral once daily dose of 1200 mg of BIA 2-093 plus single-dose of a contraceptive for 15 days

Intervention Type

Drug

Intervention Name(s)

BIA 2-093

Intervention Type

Drug

Intervention Name(s)

Contraceptives, Oral, Combined

Primary Outcome Measure Information:

Title

Cmax - Maximum Observed Plasma BIA 2-194 Concentration

Description

Cmax - Maximum observed plasma BIA 2-194 concentration on days 1, 2, 4, 6, 8, 10, 12, 14 and 15 during a 15-day oral regimen of BIA 2-093 1200 mg once-daily.

Time Frame

Days 1, 2, 4, 6, 8, 10, 12, 14 and 15 during a 15-day oral regimen of BIA 2-093 1200 mg once-daily.

Secondary Outcome Measure Information:

Title

Cmax

Description

Time Frame

pre-dose, on Days 1, 2, 4, 6, 8, 10, 12, 14 and 15 of the BIA 2-093 + OC period.

Title

Tmax

Description

Time Frame

pre-dose, on Days 1, 2, 4, 6, 8, 10, 12, 14 and 15 of the BIA 2-093 + OC period.

Title

AUC0-t

Description

Time Frame

pre-dose, on Days 1, 2, 4, 6, 8, 10, 12, 14 and 15 of the BIA 2-093 + OC period.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Pre-menopausal female; Able and willing to give written informed consent; Aged 18 to 40 years, inclusive; Not pregnant or breast-feeding; Body mass index (BMI) between 19 and 30 kg/m2, inclusive; Healthy as determined by medical history, physical examination, complete neurological examination, vital signs, and 12-lead ECG; Clinical laboratory tests with clinically acceptable results at screening and admission to the first period; Negative tests for HBsAg, anti-HCV Ab and HIV-1 and HIV-2 Ab at screening; Negative test for drugs of abuse at screening; Non-smoker or smokes less than 10 cigarettes or equivalent per day; Agreed to either practice abstinence or use a double-barrier or intra-uterine device from screening until the follow-up visit; Negative pregnancy test at screening and admission to the first period. Exclusion Criteria: Had any contra-indication to the use of oral contraceptives; Had experienced notable adverse events while on any oral contraceptive; Had a history of alcoholism or drug abuse; Had a relevant history or presence of respiratory, gastrointestinal, renal, hepatic,haematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, endocrine, connective tissue diseases or disorders; Had acute gastrointestinal symptoms at the time of screening or admission to the first period; Had a significant infection or inflammatory process at the time of screening or admission to the first period; Had a relevant surgical history; Had a relevant family history; Had a history of relevant drug hypersensitivity (e.g., carbamazepine or oxcarbazepine); Had used relevant prescription or over-the-counter medication within 2 weeks ofadmission to the first period; Consumed more than 14 units of alcohol a week; Had participated in any clinical trial within 3 months prior to screening; Had previously received BIA 2-093; Had donated or received any blood or blood products within 2 months prior to screening; Was unlikely to co-operate with the requirements of the study.

Facility Information:

Facility Name

BIAL - Portela & Cª, S.A.

City

S. Mamede do Coronado

ZIP/Postal Code

4045-457

Country

Portugal

12. IPD Sharing Statement

Learn more about this trial

Effect of BIA 2-093 on the Pharmacokinetics of a Combined Oral Contraceptive.

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