effect of bia 9-1067 on rasagiline pharmacokinetics

Conditions: Parkinson Disease

Summary: the purpose of this study is to investigate the effect of bia 9-1067 on rasagiline pharmacokinetics in healthy subjects.

single-centre, open-label, randomised, three-way crossover study consisting of 3 single-dose periods separated by a washout of 14 days or more

Eligibility criteria:
inclusion criteria: * subjects who were 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 18.0 and 30.0 kg/m2, inclusive. * subjects who were healthy as determined by pre-study medical history, physical examination, vital signs, complete neurological examination and 12-lead ecg. * subjects who had negative tests for hbsag, anti-hcvab and hiv-1 and hiv-2 ab at screening * subjects who had clinical laboratory test results clinically acceptable at screening and admission to each treatment period. * subjects who had a negative screen for alcohol and drugs of abuse at screening and admission to each treatment period. * subjects who were 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 pregnancy test (β-hcg) at screening and admission to each treatment period. exclusion criteria: * subjects who had a 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. * subjects who had a clinically relevant surgical history. * subjects who had any significant abnormality in the coagulation tests. * subjects who had any significant abnormality in the liver function tests (a case-by-case decision for any abnormality was to be discussed with the sponsor before inclusion). * subjects who had a history of relevant atopy or drug hypersensitivity. * subjects who had a history of alcoholism or drug abuse. * subjects who consumed more than 14 units of alcohol a week. * subjects who had a significant infection or known inflammatory process at screening or admission to each treatment period. * subjects who had acute gastrointestinal symptoms (e.g., nausea, vomiting, diarrhoea, heartburn) at the time of screening or admission to each treatment period. * subjects who had received fluoxetine within 5 weeks of admission to the first period. * subjects who had used any other medicines within 2 weeks of admission to first period that could affected the safety or other study assessments, in the investigator's opinion. * subjects who had previously received bia 9-1067. * subjects who have used any investigational drug or participated in any clinical trial within 90 days prior to screening. * subjects who have donated or received any blood or blood products within the 3 months prior to screening. * subjects who were vegetarians, vegans or have medical dietary restrictions. * subjects who could not communicated reliably with the investigator. * subjects who were unlikely to co-operate with the requirements of the study. * subjects who were unwilling or unable to give written informed consent. * (if female) she was pregnant or breast-feeding. * (if female) she was of childbearing potential and she did not use an approved effective contraceptive method (double-barrier, intra-uterine device) or she uses oral contraceptives.

Keywords: parkinson disease bia 9-1067