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

NCT02281448 | Completed Phase 1 Results

• 1 other identifier: BIA-2093-114
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Conditions

Epilepsy

Outcome Measures

Primary Outcomes (1)

• 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.

  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 (3)

• Cmax

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

• Tmax

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

• AUC0-t

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

Study Arms (2)

Treatment sequence A

OTHER

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

OTHER

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

Interventions

BIA 2-093 DRUG

Treatment sequence A; Treatment sequence B

Contraceptives, Oral, Combined DRUG

Treatment sequence A; Treatment sequence B

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bial - Portela C S.A.: lead

Study Sites (1)

BIAL - Portela & Cª, S.A.

S. Mamede Do Coronado, S. Mamede Do Coronado, 4045-457, Portugal

Location

MeSH Terms

Conditions

Epilepsy

Interventions

eslicarbazepine acetate; Contraceptives, Oral, Combined

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Drug Combinations; Pharmaceutical Preparations; Contraceptives, Oral; Contraceptive Agents, Female; Contraceptive Agents; Reproductive Control Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Therapeutic Uses

Results Point of Contact

• Title: Head of Clinical Research
• Organization: Bial - Portela & Cª, S.A.

jose.rocha@bial.com

+351 229 866 100

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2014
• First Posted: November 3, 2014
• Study Start: March 1, 2005
• Primary Completion: May 1, 2005
• Study Completion: May 1, 2005
• Last Updated: December 3, 2014
• Results First Posted: December 3, 2014

Record last verified: 2014-11

Locations

PT (1)