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:
2025-12-24 @ 7:02 PM
Ignite Modification Date:
2025-12-24 @ 7:02 PM
NCT ID:
NCT01594957
Eligibility Criteria:
Inclusion criteria:
Individuals with hepatic impairment only
• Hepatic impairment evidenced by a Child-Pugh score
* Mild hepatic impairment defined Child-Pugh Class A (5-6 points)
* Moderate hepatic impairment defined Child-Pugh Class B (7-9 points)
* Severe hepatic impairment defined Child-Pugh Class C (10-15 points).
Healthy subjects only
• Good health determined.
Exclusion criteria:
All Individuals
* A past medical history of clinically significant ECG abnormalities or a family history of a prolonged QT-interval syndrome.
* Female subjects must be of non child bearing potential or use an effective method of contraception.
Individuals with hepatic impairment
* History of drug or alcohol abuse within 3 months prior to dosing.
* History or presence of significant uncontrolled disease of any major organ class.
* Any surgical or medical condition other than hepatic impairment which might alter the drug metabolism.
Healthy subjects
* History or presence of significant uncontrolled disease of any major organ class.
* Any surgical or medical condition other than hepatic impairment which might alter the drug metabolism.
* History or presence of hepatitis B or C and/or positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result at screening.
Other protocol-defined inclusion/exclusion criteria may apply.
Healthy Volunteers:
True
Sex:
ALL
Study:
NCT01594957
Study Brief:
Protocol Section:
NCT01594957