effect of bia 9-1067 on the pharmacokinetics and pharmacodynamics of warfarin

Conditions: Parkinson's Disease (PD)

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.

single-centre, open-label, randomised, two-way crossover study in healthy young male and female volunteers. the study was to consist of 2 treatment periods separated by a washout period of 14 days or more. in one period, subjects were to receive a single-dose of 25 mg bia 9-1067 with a single-dose of racemic 25 mg warfarin. in the other period, a 25 mg warfarin single-dose was to be administered alone.

Eligibility 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.

Keywords: parkinson's disease (pd) bia 9-1067 opicapone