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:
2025-12-26 @ 2:42 PM
Ignite Modification Date:
2025-12-26 @ 2:42 PM
NCT ID:
NCT01010906
Eligibility Criteria:
Inclusion Criteria:
Hepatic Participants:
* Females of reproductive potential test negative for pregnancy and agree to use an appropriate method of contraception during the study
* Apart from hepatic insufficiency, is in good general health
* Has a diagnosis of chronic stable hepatic insufficiency
* Score on the Child-Pugh scale ranged from 5 to 6 (mild hepatic insufficiency); from 7 to 9 (moderate hepatic insufficiency); from 10 to 15 (severe hepatic insufficiency). Moderate and Severe participants must have had a 50% score of 2 or higher on at least one of the laboratory parameters (i.e., albumin, prothrombin time, bilirubin) at the prestudy visit.
Healthy Matched Participants:
* Females of reproductive potential test negative for pregnancy and agree to use an appropriate method of contraception during the study
* Is in good health
Exclusion Criteria:
* Female is pregnant, lactating, expecting to become pregnant or donate eggs
* Has a history of stroke or seizures
* Has a history of cancer
* Is unable to refrain from the use of any prescription or non-prescription medication
* Consumes excessive amounts of alcohol or caffeinated beverages daily
* Has had surgery, donated blood or participated in another investigational study with in the last 4 weeks
* Is a regular user or past abuser of any illicit drug including alcohol
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
45 Years
Maximum Age:
65 Years
Study:
NCT01010906
Study Brief:
Protocol Section:
NCT01010906