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 @ 4:04 PM
Ignite Modification Date:
2025-12-24 @ 4:04 PM
NCT ID:
NCT02101866
Eligibility Criteria:
Inclusion Criteria:
* Must be male or female between 18 and 55 years of age (inclusive) with BMI between 18 and 30 kg/m2 (inclusive), and weight ≥50 kg at the time of screening
* Capable of giving written informed consent
* Subject is able to understand and comply with the protocol requirements, instructions and restrictions
* Healthy on the basis of physical examination, medical history, medication usage, VS, ECGs, and clinical laboratory tests
* Female subjects must be of non-childbearing potential
* Male subjects must agree to use a double barrier method of birth control
Exclusion Criteria:
* Positive results for Hepatitis B, Hepatitis C, or HIV
* Frequent use of tobacco products, including cigarettes, cigars, chewing tobacco
* A medical history of significant hematological, gastrointestinal, respiratory, renal, hepatic, cerebrovascular, immunologic, psychiatric or cardiovascular disease or event; Current or recent respiratory infection
* Presence or history of significant allergy
* Clinically significant abnormalities noted on ECG
* Screening vital signs representing sustained elevated blood pressure
* Presence of significant gastrointestinal abnormalities
* Safety laboratory abnormalities noted at screening which are clinically significant
* Current or defined history of abuse of alcohol or illicit drugs
* A positive pregnancy test at screening
* Poor vein access or fear of venipuncture or sight of blood
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT02101866
Study Brief:
Protocol Section:
NCT02101866