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 @ 1:20 AM
Ignite Modification Date:
2025-12-25 @ 1:20 AM
NCT ID:
NCT01209793
Eligibility Criteria:
Inclusion Criteria:
* Healthy men and women between the ages of 18 and 65; women must be postmenopausal or surgically sterile
* Body Mass Index (BMI) between 18.0 and 30.0 kg/m2, inclusive
* Normal vital signs after resting in a sitting position for 5 minutes:
* Normal standard 12-lead ECG
* Willing and able to comply with clinic visits and study-related procedures
* Provide signed informed consent
* Able to understand and complete study-related questionnaires
Exclusion Criteria:
* Current or prior history of smoking
* Any illness or condition that would adversely affect the subject's participation in this study
* Hospitalization within 60 days of the screening visit
* Any clinically significant abnormalities observed during the screening visit
* History of or positive human immunodeficiency virus (HIV) screen result at the screening visit
* History of positive blood test for hepatitis B/hepatitis C or positive hepatitis screen result at the screening visit
* History of positive drug screen result for drug or alcohol abuse within a year prior to the screening visit
* Known sensitivity to any of the components of the Investigational Product formulation
* Participation in any clinical research study evaluating another investigational drug or therapy within 30 days or at least 5 half-lives (whichever is longer), of the investigational drug prior to the screening visit
* Any condition that would place the subject at risk, interfere with participation in the study
* History of a parasitic infection or recent (within the previous 6 months) travel to a parasitic endemic area
* Live/attenuated vaccinations within 12 weeks of screening or during the study
* Any subjects with planned elective surgery
* Sexually active men who are unwilling to utilize adequate contraception
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01209793
Study Brief:
Protocol Section:
NCT01209793