Clinical trial NCT02281448: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Epilepsy
Lead sponsor: Bial - Portela C S.A.
Sponsor class: INDUSTRY
First posted: 2014-11-02
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Cmax - Maximum Observed Plasma BIA 2-194 Concentration
timeFrame: 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 outcomes:
measure: Cmax
timeFrame: pre-dose, on Days 1, 2, 4, 6, 8, 10, 12, 14 and 15 of the BIA 2-093 + OC period.
measure: Tmax
timeFrame: pre-dose, on Days 1, 2, 4, 6, 8, 10, 12, 14 and 15 of the BIA 2-093 + OC period.
measure: AUC0-t
timeFrame: pre-dose, on Days 1, 2, 4, 6, 8, 10, 12, 14 and 15 of the BIA 2-093 + OC period.
Other outcomes:
Locations:
city: S. Mamede do Coronado
country: Portugal
facility: BIAL - Portela & Cª, S.A.
Study officials:
References: