effect of food on opicapone

Conditions: Parkinson Disease

Summary: the purpose of this study is to investigate the effect of food on the catechol-o-methyltransferase (comt) activity after repeated doses of opicapone (opc, development code bia 9-1067) in healthy subjects and to characterize the effects of food on the pharmacokinetics (pk) and tolerability of opc after repeated doses.

single-centre, open-label, single-arm study in 28 healthy subjects. subjects received a single-dose of 50 mg opc once-daily (qd) in the evening for 12 days. on day 1 (d1), 50 mg opc was orally administered in the evening (reference hour for all other administrations) after a minimum of 6 hours fast. from d2 to d8 subjects were in ambulatory and received 50 mg opc once-daily (evening administration after 2 hours fast). on d9, 50 mg opc was orally administered in the evening after a minimum of 6 hours fast. on d10, 50 mg opc was orally administered in the evening, thirty minutes after the start of a moderate meal (with a previous 6 hours fast). on d11 and d12 subjects received the last doses of 50 mg opc (evening administration after 2 hours fast).

Eligibility criteria:
inclusion criteria: * able and willing to give written informed consent and to comply with the study restrictions. * male or female subjects aged between 18 and 45 years, inclusive. * 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-hcv ab and hiv-1 and hiv-2 ab at screening. * clinical laboratory test results clinically acceptable at screening and admission. * negative screen for alcohol and drugs of abuse at screening and admission. * non-smokers or ex-smokers for at least 3 months. * if female: * not of childbearing potential by reason of surgery or, if of childbearing potential, she uses an effective non-hormonal method of contraception (intrauterine device or intrauterine system; condom or occlusive cap \[diaphragm or cervical or vault caps\] with spermicidal foam or gel or film or cream or suppository; true abstinence; or vasectomized male partner, provided that he is the sole partner of that subject) for all the duration of the study. * negative serum pregnancy test at screening and a negative urine pregnancy test on admission. 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. * clinically relevant abnormality in the coagulation tests. * clinically relevant abnormality in the liver function tests. * history of relevant atopy or drug hypersensitivity, particularly to any comt inhibitor. * history of alcoholism or drug abuse. * consume more than 14 units of alcohol a week. * significant infection or known inflammatory process at screening or admission. * acute gastrointestinal symptoms (e.g., nausea, vomiting, diarrhoea, heartburn) at the time of screening or admission. * used medicines within 2 weeks of admission that may affect the safety or other study assessments, in the investigator's opinion. * previously received opc. * used any investigational drug or participated in any clinical trial within 90 days prior to screening. * participated in more than 2 clinical trials within the 12 months prior to screening. * donated or received any blood or blood products within the 3 months prior to screening. * vegetarians, vegans or have medical dietary restrictions. * cannot communicate reliably with the investigator. * unlikely to co-operate with the requirements of the study. * if female: * pregnant or breast-feeding. * of childbearing potential and not used an approved effective contraceptive method or she uses oral contraceptives.