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 @ 2:39 PM
Ignite Modification Date:
2025-12-24 @ 2:39 PM
NCT ID:
NCT02089659
Eligibility Criteria:
Inclusion Criteria:
* Body Mass Index (BMI) between 19 and 40 kg/m\^2
* Continuous non-smoker or moderate smoker of \<20 cigarettes or equivalent per day. Agrees to consume \<=10 cigarettes or equivalent per day from the time of screening through the period of sample collection.
* In good health and with no clinically significant electrocardiogram abnormality
* Hepatic impairment participants: diagnosis of chronic (\>6 months), stable hepatic insufficiency with features of cirrhosis due to any etiology. Part 1 only: score of 7 to 9 on the Child-Pugh scale. Part 2: score of 5 to 6 on the Child-Pugh scale.
* Females of childbearing potential: sexually inactive for \>=14 days before study drug administration and throughout the study, or using 2 acceptable methods of barrier contraception from screening until 14 days after study drug administration.
Exclusion Criteria:
* Mentally or legally incapacitated or has significant emotional problems at the time of screening or expected during the study
* History or presence of clinically significant medical or psychiatric condition or disease
* History or presence of drug abuse within the past 2 years
* History or presence of hypersensitivity or idiosyncratic reaction to the study drug or related compounds
* Female participant who is pregnant or lactating
* Positive results for breath alcohol or urine drug screen (unless due to prescription drug use and is approved by the investigator) at screening
* Positive for HIV at screening
* Unable to refrain from or anticipates the use of any drug known to be a significant inhibitor or inducer of cytochrome oxidase CYP3A or P-glycoprotein, or any medication or substance which cannot be discontinued at least 14 days before study drug administration and throughout the study.
* Donation of \>500 mL of blood or had significant blood loss within 56 days before study drug administration
* Plasma donation within 7 days before study drug administration
* Dosed in another clinical trial within 28 days before study drug administration
* Healthy control participants only: positive for hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV) at screening;
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT02089659
Study Brief:
Protocol Section:
NCT02089659