study of bia 9-1067 to investigate its effect on levodopa pharmacokinetic

Conditions: Parkinson Disease

Summary: to investigate the effect of repeated dosing of bia 9-1067 on the levodopa pharmacokinetics, in comparison to placebo and entacapone.

single-centre, double-blind, randomised, parallel-group study in 80 young male and female healthy subjects.

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 the treatment period. * negative screen for alcohol and drugs of abuse at screening and admission to the 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: intrauterine device (by the subject) and condoms (by the partner) or diaphragm (by the subject) and condoms (by the partner) or spermicide (by the subject) and condoms (by the partner). * (if female) she had a negative urine pregnancy test at screening and admission to the 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. * any abnormality in the coagulation tests. * any abnormality in the liver function tests. * a history of relevant atopy or drug hypersensitivity. * a history or presence of narrow-angle glaucoma. * a suspicious undiagnosed skin lesions or a history of melanoma. * 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 the treatment period. * acute gastrointestinal symptoms (e.g., nausea, vomiting, diarrhoea, heartburn) at the time of screening or admission to the treatment period. * had used non-selective monoamine oxidase (mao) inhibitors within 2 weeks of admission to the treatment period. * had used medicines within 2 weeks of admission to the treatment 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. * (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 or she used oral contraceptives.

Keywords: parkinson disease bia 9-1067