Effect of Food on BIA 5-1058

• Status: Completed
• Trial end date: 2015-09-22
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Bial - Portela C S.A.
• Treatments: Zamicastat

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.