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 @ 4:05 AM
Ignite Modification Date:
2025-12-25 @ 4:05 AM
NCT ID:
NCT03309202
Eligibility Criteria:
Key Exclusion Criteria:
All subjects -
* Adults \<18 years of age and \>70 years of age
* BMI \< 17.5 and \> 35.4 kg/m2
* HIV positive
* Conditions that affect drug absorption
* Positive breath alcohol test
Healthy/ those without hepatic impairment -
* Known or suspected hepatic impairment
* Evidence of Hepatitis B or C
* On any chronic medications
Those with varying degrees of hepatic impairment -
* Not meeting Classification A, B, or C of hepatic impairment based on Child-Pugh Classification
* Evidence of Hepatic carcinoma or hepatorenal syndrome or limited predicted life expectancy
* Recent GI bleed
* Moderate or severe renal impairment
* Hepatic encephalopathy Grade 3 or higher
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT03309202
Study Brief:
Protocol Section:
NCT03309202