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 @ 6:50 PM
Ignite Modification Date:
2025-12-24 @ 6:50 PM
NCT ID:
NCT02322957
Eligibility Criteria:
Inclusion Criteria:
* Capable of giving written informed consent
* Non-tobacco user for at least 3 months prior to selection
* Healthy on the basis of physical examination, medical history, ECG and clinical laboratory testing at screening
Exclusion Criteria:(must NOT meet the following)
* Infected with Hepatitis A, B, C, or HIV
* History of or any current medical condition which could impact safety of the participant
* A positive urine drug test
* Consumption of more than 2 units of alcoholic beverages per day or more than 14 per week
* Received an investigational drug or vaccine or used an investigational medical device within 3 months or 5 half-lives before the planned start of treatment or prior treatment with FV-100
* Subjects who have used any drugs or substances known to inhibit or induce cytochrome(CYP) P450 enzymes and/or P-gp within 28 days prior to the first dose and throughout study
* Subjects who have, within 2 weeks prior to the first dose of study drug, ingested grapefruit or grapefruit juice, apple or orange juice, vegetables from the mustard green family or charbroiled meats
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT02322957
Study Brief:
Protocol Section:
NCT02322957