effect of food on bia 5-1058

Conditions: Pulmonary Arterial Hypertension

Summary: the aim of this study is to investigate the effect of food on the pharmacokinetic (pk) profile of bia 5-1058 after a single dose in healthy subjects.

single-centre, open-label, randomised, single-dose, three-way crossover, three-part study in 54 healthy subjects. duration of treatment: the study comprised a screening evaluation between 2 and 28 days before the first imp (investigational medicinal product) administration and 3 treatment periods of approximately 4 days, separated by wash-out periods of at least 7 days. a follow-up visit was performed approximately 7 days after discharge from the last period or early discontinuation. for each subject, the full duration of the participation in the study was approximately 9 weeks.

Eligibility criteria:
inclusion criteria: 1. able and willing to give written informed consent and to comply with the study restrictions; 2. male or female subjects aged 18 to 45 years, inclusive; 3. body mass index (bmi) between 18 and 30 kg/m2, inclusive; 4. healthy as determined by pre-study medical history, physical examination, vital signs, complete neurological examination and 12-lead electrocardiogram (ecg); 5. negative tests for hepatitis b surface antigen (hbsag), anti-hepatitis c virus antibodies (hcv ab) and anti-human immunodeficiency virus antibodies (hiv-1 and hiv-2 ab) at screening; 6. clinical laboratory test results clinically acceptable at screening and admission to each treatment period; 7. negative screen for alcohol and drugs of abuse at screening and admission to each treatment period; 8. non-smokers or ex-smokers for at least 3 months. if female: 9. no childbearing potential by reason of surgery or at least 1 year post menopause (i.e., 12 months post last menstrual period), or menopause confirmed by follicle-stimulating hormone (fsh) testing; 10. if of childbearing potential, she was using 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; 11. negative serum pregnancy test at screening and negative urine pregnancy test on admission of each treatment period (women of childbearing potential only). if male: 12. using an effective method of contraception with a pregnant partner or partner of childbearing potential (condom or occlusive cap \[diaphragm or cervical or vault caps\] with spermicidal foam or gel or film or cream or suppository; true abstinence; or vasectomy) throughout the study; 13. refraining from donating sperm throughout the study. exclusion criteria: 1. 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; 2. clinically relevant surgical history; 3. history of relevant atopy or drug hypersensitivity; 4. history of alcoholism or drug abuse; 5. consumption of more than 14 units of alcohol a week \[1 glass (25 cl) of beer with 3° of alcohol = 7.5 g, or 1 glass (25 cl) of beer with 6° of alcohol = 15 g, or 1 glass (12.5 cl) of wine with 10° of alcohol = 12 g, or 1 glass (4cl) of aperitif with 42° of alcohol = 17 g\]; 6. significant infection or known inflammatory process at screening or admission to each treatment period; 7. display of acute gastrointestinal symptoms (e.g., nausea, vomiting, diarrhoea, heartburn) at the time of screening or admission to each treatment period; 8. use of medicines within 2 weeks of admission to the first period that may could affect the safety or other study assessments, in the investigator's opinion; 9. previous administration of bia 5-1058; 10. use of any investigational drug or participation in any clinical trial within 90 days prior to screening; 11. participation in more than 2 clinical trials within the 12 months prior to screening; 12. donation or reception of any blood or blood products within the 3 months prior to screening; 13. vegetarians, vegans or had any other medical dietary restrictions; 14. not able to communicate reliably with the investigator; 15. unlikely to co-operate with the requirements of the study. if female: 16. pregnant or breastfeeding; 17. not using an accepted effective contraceptive method or was using oral contraceptives. if male: 18. not using an accepted effective method of contraception; 19. refusing to refrain from donating sperm throughout the study.