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 @ 6:55 PM
Ignite Modification Date:
2025-12-24 @ 6:55 PM
NCT ID:
NCT03219957
Eligibility Criteria:
Inclusion Criteria:
All subjects (healthy and HCV-infected subjects):
* Must agree to use two methods of birth control from Screening through 90 days after administration of the last dose of study drug
* Must have a negative pregnancy test at Screening and prior to dosing
* Minimum body weight of 50 kg
* Willing to comply with the study requirements and to provide written informed consent
Additional inclusion criteria for HCV-infected subjects:
* Must have not received prior treatment for HCV infection
* Documented clinical history compatible with chronic HCV infection
* Plasma HCV RNA ≥ 5.0 log10 IU/mL at Screening.
Exclusion Criteria:
All subjects (healthy and HCV-infected subjects):
* Pregnant or breastfeeding
* Infected with hepatitis B virus or HIV
* Abuse of alcohol or drugs
* Use of other investigational drugs within 28 days of dosing
* Other clinically significant medical conditions or laboratory abnormalities
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT03219957
Study Brief:
Protocol Section:
NCT03219957