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 @ 3:56 AM
Ignite Modification Date:
2025-12-25 @ 3:56 AM
NCT ID:
NCT00715702
Eligibility Criteria:
Inclusion Criteria:
* Provision of signed written informed consent.
* Females should not be of childbearing potential
* Subjects classified as renally impaired should have been stable (in the Investigator's opinion) for at least 3 months prior to Visit 1.
Exclusion Criteria:
* Patients taking prescription of medications: Pgp substrates, inhibitors and /or inducers, medications that affect creatinine clearance(within 7 days of dosing), atorvastatin \>20mg once daily, medications that prolong QT/QTc interval
* Change in dose regimen of prescribed medication and NSAIDs within the 2 weeks before enrolment (renal patients only)
* Participation in another clinical study involving administration of an investigational product in the 3 months prior to treatment (or within 5 half-lives of the last dose of the investigational product, whichever is longer)
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00715702
Study Brief:
Protocol Section:
NCT00715702