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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT02281448
• Date of registration: 30/10/2014
• Prospective Registration: No
• Primary sponsor: Bial - Portela C S.A.
• Public title: Effect of BIA 2-093 on the Pharmacokinetics of a Combined Oral Contraceptive.
• Scientific title: Effect of BIA 2-093 on the Pharmacokinetics of a Combined Oral Contraceptive in Healthy Female Volunteers
• Date of first enrolment: March 2005
• Target sample size: 20
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02281448
• Study type: Interventional
• Phase: Phase 1

Countries of recruitment

Portugal

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 40 Years
Gender: All

Health Condition(s) or Problem(s) studied

Epilepsy

Intervention(s)

Drug: BIA 2-093

Drug: Contraceptives, Oral, Combined

Primary Outcome(s)

Cmax - Maximum Observed Plasma BIA 2-194 Concentration [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(s)

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

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

AUC0-t [Time Frame: pre-dose, on Days 1, 2, 4, 6, 8, 10, 12, 14 and 15 of the BIA 2-093 + OC period.]

Secondary ID(s)

BIA-2093-114

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 03/12/2014
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02281448