Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:28 AM
Ignite Modification Date:
2025-12-25 @ 1:28 AM
NCT ID:
NCT04991194
Eligibility Criteria:
Inclusion Criteria:
All subjects (young and elderly):
1. A signed and dated informed consent form before any study-specific screening procedure was performed;
2. Healthy male and female subjects as determined by the Investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs and digital 12-lead electrocardiogram (ECG);
3. Non-smoker or ex-smokers for at least 3 months at screening;
4. BMI between 18 and 30 kg/m2, inclusive;
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 the study;
7. Negative screen for alcohol and drugs of abuse at screening and admission to the study;
If male:
8. 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;
9. Refraining from donating sperm throughout the study.
Young subjects only:
10. Males and females aged between 18 and 40 years, inclusive.
If female:
11. 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;
12. If of childbearing potential, 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;
13. If of childbearing potential, negative serum pregnancy test at screening and negative urine pregnancy test on admission to the study.
Elderly subjects only:
14. Males and females older than 65 years, inclusive.
Exclusion Criteria:
All subjects (young and elderly):
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 \[1 unit corresponds to 1 glass of 12° wine (10 cL), 1 glass of 45° pastis (2.5 cL), 1 glass of 40° whisky (2.5 cL), 1 glass of 12° champagne (10 cL), 1 glass of 18°aperitif drink (7 cL) or one 25-cL glass of 5°beer\];
6. Significant infection or known inflammatory process at screening or admission to study;
7. Acute gastrointestinal symptoms (e.g., nausea, vomiting, diarrhoea, heartburn) at the time of screening or admission to the study;
8. Previous use of BIA 5-1058;
9. Use of any investigational drug or participation in any clinical trial within 90 days prior to screening;
10. Participation in more than 2 clinical trials within the 12 months prior to screening;
11. Donation or reception of any blood or blood products within the 3 months prior to screening;
12. Vegetarians, vegans or other medical dietary restrictions;
13. Not able to communicate reliably with the Investigator;
14. Unlikely to co-operate with the requirements of the study.
If male:
15. Not using an accepted effective method of contraception;
16. Refusing to refrain from donating sperm throughout the study.
Young subjects only:
17. Use of medicines within 2 weeks of admission that could affect the safety or other study assessments, in the Investigator's opinion;
If female of childbearing potential:
18. Pregnant or breastfeeding;
19. Not using an accepted effective contraceptive method or using oral contraceptives.
Elderly subjects only:
20. For elderly subjects, previously prescribed medications that interfered with absorption, distribution, metabolism, and excretion or safety/tolerability evaluation of BIA 5-1058 and adrenal or renal function were prohibited; however, previously prescribed medications that did not interfere with absorption, distribution, metabolism, and excretion or safety/tolerability evaluation of BIA 5-1058, adrenal or renal function and which could not interfere with the objectives of the study were allowed if the dose regimen had been stable for at least 4 weeks and was expected to remain stable throughout the study. Such concomitant medications were to be reviewed and mutually agreed upon by the Sponsor and the Investigator.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04991194
Study Brief:
Protocol Section:
NCT04991194