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

Phase 1

Completed

• Conditions: Epilepsy
• Interventions: Drug: BIA 2-093; Drug: Contraceptives, Oral, Combined

• Registration Number: NCT02281448
• Lead Sponsor: Bial - Portela C S.A.

Brief Summary

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 with an oral once daily dose of 1200 mg of BIA 2-093

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.

Study Timeline

• Study Start: 2005-03
• Primary Completion: 2005-05
• Study Completion: 2005-05
• Study First Submitted: 2014-10-30
• Study First Submitted QC: 2014-10-30
• Status Verified: 2014-11
• Study First Posted: 2014-11-02
• Results First Submitted: 2014-11-28
• Results First Submitted QC: 2014-11-28
• Last Update Submitted: 2014-11-28
• Results First Posted: 2014-12-03
• Last Update Posted: 2014-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Treatment sequence A	Contraceptives, Oral, Combined	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
Treatment sequence B	BIA 2-093	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
Treatment sequence B	Contraceptives, Oral, Combined	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
Treatment sequence A	BIA 2-093	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

Primary Outcome Measures

Name	Time	Method
Cmax - Maximum Observed Plasma BIA 2-194 Concentration	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.	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

Name	Time	Method
Tmax	pre-dose, on Days 1, 2, 4, 6, 8, 10, 12, 14 and 15 of the BIA 2-093 + OC period.	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)
Cmax	pre-dose, on Days 1, 2, 4, 6, 8, 10, 12, 14 and 15 of the BIA 2-093 + OC period.	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)
AUC0-t	pre-dose, on Days 1, 2, 4, 6, 8, 10, 12, 14 and 15 of the BIA 2-093 + OC period.	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)

Trial Locations

Locations (1)

BIAL - Portela & Cª, S.A.; 🇵🇹 S. Mamede do Coronado, Portugal