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 @ 4:57 AM
Ignite Modification Date:
2025-12-25 @ 4:57 AM
NCT ID:
NCT01111318
Eligibility Criteria:
Inclusion criteria:
Healthy males and females. Hepatically impaired male and female subjects. Age: 18 - 75 years, BMI: 18-34 kg/m2 Creatinine clearance \>80 mL/min (except for patients with severe hepatic impairment, see exclusion criteria.
Signed and dated written informed consent prior to admission to the study in accordance with GCP and the local legislation.
Exclusion criteria:
Healthy subjects (group 1)
1. Significant gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders as judged by the investigator.
2. Relevant gastrointestinal tract surgery.
3. Diseases of the central nervous system or psychiatric disorders or relevant neurological disorders.
4. History of relevant orthostatic hypotension, fainting spells or blackouts; systolic blood pressure \< 100 or \> 160 mm Hg, diastolic blood pressure \< 60 or \> 100 mm Hg, pulse rate \< 50 or \> 100 1/min.
5. Chronic or relevant acute infections.
6. History of allergy/hypersensitivity.
7. Intake of drugs with a long half-life (\>24 hours) within at least one month or less than 10 half-lives of the respective drug prior to administration or during the trial.
8. Use within 10 days prior to administration or during the trial of drugs which might reasonably influence the results of the trial based on the knowledge at the time of protocol preparation
9. Participation in another trial with an investigational drug within 2 months after a multiple dose study or within 1 month after a single dose study.
10. Smoker (more than 10 cigarettes or 3 cigars or 3 pipes per day).
11. Inability to refrain from smoking when confined to the study site on trial days.
12. Alcohol abuse, drug abuse.
13. Veins unsuited for iv puncture on either arm.
14. Blood donation (more than 100 mL within four weeks prior to administration or during the trial).
15. Excessive physical activities (within 48 hours prior to trial or during the trial).
16. Any laboratory value outside the reference range that is of clinical relevance.
17. Inability to comply with dietary regimen of study centre.
18. Subjects not able to understand and comply with protocol requirements, instructions and protocol-stated restrictions.
Hepatically impaired subjects (group 2-4):
19. Decompensated gastrointestinal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders.
20. For patients with severe liver impairment (Child-Pugh C): Severe concurrent renal dysfunction (e.g., due to hepato-renal syndrome) and a creatinine clearance \<40mL/min.
21. Relevant gastrointestinal tract surgery.
22. Diseases of the central nervous system or psychiatric disorders or relevant neurological disorders.
23. Chronic or relevant acute infections.
24. History of allergy/hypersensitivity.
25. Intake of drugs with a long half-life (\>24 hours) within at least one month or less than 10 half-lives of the respective drug prior to administration or during the trial.
26. Use within 10 days prior to administration or during the trial of drugs which might reasonably influence the results of the trial based on the knowledge at the time of protocol preparation. Co-medication known to inhibit or induce P-glycoprotein (such as quinidine, cyclosporine, amiodarone) is not allowed. In dubious cases, a case by case decision will be made after consultation with the sponsor.
27. Participation in another trial with an investigational drug within 2 months after a multiple dose study or within 1 month after a single dose study.
28. Smoker (more than 10 cigarettes or 3 cigars or 3 pipes per day).
29. Inability to refrain from smoking when confined to the study site on trial days.
30. Alcohol abuse, Drug abuse.
31. Blood donation (more than 100 mL within four weeks prior to administration or during the trial).
32. Excessive physical activities (within 48 hours prior to trial or during the trial).
33. Clinically relevant laboratory abnormalities.
34. Inability to comply with dietary regimen of study centre.
35. Subjects not able to understand and comply with protocol requirements, instructions and protocol-stated restrictions
For female subjects of all groups:
36. Pregnancy
37. Positive pregnancy test
38. No adequate contraception during the study and until 2 months after study completion.
39. Lactation period.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT01111318
Study Brief:
Protocol Section:
NCT01111318