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

• ClinicalTrials.gov Identifier: NCT02281448
• Recruitment Status: Completed
• First Posted: November 2, 2014
• Results First Posted: December 3, 2014
• Last Update Posted: December 3, 2014
• Sponsor: Bial - Portela C S.A.
• Information provided by (Responsible Party): Bial - Portela C S.A.

Study Description

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

Condition or disease	Intervention/treatment	Phase
Epilepsy	Drug: BIA 2-093; Drug: Contraceptives, Oral, Combined	Phase 1

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Effect of BIA 2-093 on the Pharmacokinetics of a Combined Oral Contraceptive in Healthy Female Volunteers
• Study Start Date: March 2005
• Actual Primary Completion Date: May 2005
• Actual Study Completion Date: May 2005

Arms and Interventions

Arm	Intervention/treatment
Treatment sequence A; 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	Drug: BIA 2-093; Drug: Contraceptives, Oral, Combined
Treatment sequence B; 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	Drug: BIA 2-093; Drug: Contraceptives, Oral, Combined

Outcome Measures

Primary Outcome Measures :

1. 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. ]
   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 :

1. Cmax [ Time Frame: 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)
2. Tmax [ Time Frame: 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)
3. 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. ]
   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)

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 40 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

Portugal

BIAL - Portela & Cª, S.A.

S. Mamede do Coronado, Portugal, 4045-457

Sponsors and Collaborators

Bial - Portela C S.A.

More Information

• Responsible Party: Bial - Portela C S.A.
• ClinicalTrials.gov Identifier: NCT02281448
• Other Study ID Numbers: BIA-2093-114
• First Posted: November 2, 2014
• Results First Posted: December 3, 2014
• Last Update Posted: December 3, 2014
• Last Verified: November 2014

Additional relevant MeSH terms:

Epilepsy; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Eslicarbazepine acetate; Contraceptive Agents; Contraceptives, Oral; Contraceptives, Oral, Combined; Reproductive Control Agents; Physiological Effects of Drugs; Anticonvulsants; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Contraceptive Agents, Female