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 @ 12:05 AM
Ignite Modification Date:
2025-12-25 @ 12:05 AM
NCT ID:
NCT01433458
Eligibility Criteria:
Inclusion criteria:
* All subjects:
• Female subjects must be of non-child bearing potential OR use an effective method of contraception and sexually active males must use a condom during intercourse while taking the drug and for 5 half-lives after stopping treatment
* Subjects with hepatic impairment:
* Subjects must have either mild, moderate or severe hepatic impairment
Exclusion criteria:
* All subjects
* Hepatic impairment due to non-liver disease
* Use of other investigational drugs at time of enrollment
* History of malignancy of any organ system
* Donation or loss of 400 mL or more of blood or plasma within 8 weeks prior to initial dosing
* Hemoglobin levels below 10.0 g/dL at screening or baseline
* Subjects with hepatic impairment:
* Presence of any non-controlled and clinically significant disease that could affect the study outcome or that would place the patient at undue risk
* Treatment with any cytostatic drug, vasodilator, autonomic alpha blocker or B2 agonist
* Any surgical or medical condition other than hepatic impairment which might significantly alter the distribution or excretion of drugs
Other protocol-defined inclusion/exclusion criteria may apply.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT01433458
Study Brief:
Protocol Section:
NCT01433458