Effect of BIA 9-1067 on the Pharmacokinetics and Pharmacodynamics of Warfarin

• Status: Completed
• Trial end date: 2009-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to investigate CYP2C9 inhibition by BIA 9-1067 through the assessment of its effect on the pharmacokinetics of S-warfarin, a substrate of CYP2C9.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Bial - Portela C S.A.
• Treatments: Opicapone; Warfarin

Criteria

Inclusion Criteria:

• Able and willing to give written informed consent.

• Male or female subjects aged between 18 and 45 years, inclusive.

• Subjects of body mass index (BMI) between 19 and 30 kg/m2, inclusive.

• Healthy as determined by pre-study medical history, physical examination, vital signs, complete neurological examination and 12-lead ECG.

• Negative tests for HBsAg, anti-HCVAb and HIV-1 and HIV-2 Ab at screening.

• Clinical laboratory test results clinically acceptable at screening and admission to each treatment period.

• Negative screen for alcohol and drugs of abuse at screening and admission to each treatment period.

• Non-smokers or ex-smokers for at least 3 months.

• (If female) She was not of childbearing potential by reason of surgery or, if of childbearing potential, she used one of the following methods of contraception: double barrier or intrauterine device.

• (If female) She had a negative urine pregnancy test at screening and admission to each treatment period.

Exclusion Criteria:

• Clinically relevant history or presence of respiratory, gastrointestinal, renal, hepatic, haematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, endocrine, connective tissue diseases or disorders.

• Clinically relevant surgical history.

• Personal or family history of haemostatic disorder.

• Personal or family history of bleeding complications after surgery or tooth extraction, nose or gingival bleeding, or haemorrhagic diathesis.

• Any abnormality in the coagulation tests.

• Any abnormality in the liver function tests.

• A history of relevant atopy or drug hypersensitivity.

• History of alcoholism or drug abuse.

• Consumed more than 14 units of alcohol a week.

• Significant infection or known inflammatory process at screening or admission to each treatment period.

• Acute gastrointestinal symptoms (e.g., nausea, vomiting, diarrhoea, heartburn) at the time of screening or admission to each treatment period.

• Had used medicines within 2 weeks of admission to first period that may have affected the safety or other study assessments, in the investigator's opinion.

• Had previously received BIA 9-1067.

• Had used any investigational drug or participated in any clinical trial within 6 months prior to screening.

• Had participated in more than 2 clinical trials within the 12 months prior to screening.

• Had donated or received any blood or blood products within the 3 months prior to screening.

• Vegetarians, vegans or had medical dietary restrictions.

• Cannot communicate reliably with the investigator.

• Unlikely to co-operate with the requirements of the study.

• Unwilling or unable to gave written informed consent.

• Employees at BIAL - Portela & Co, SA.

• (If female) She was pregnant or breast-feeding.

• (If female) She was of childbearing potential and she did not used an approved effective contraceptive method (double-barrier or intra-uterine device) or she used oral contraceptives.