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 @ 2:07 AM
Ignite Modification Date:
2025-12-25 @ 2:07 AM
NCT ID:
NCT01986660
Eligibility Criteria:
Inclusion Criteria:
* Signed consent form
* Men, women, 18 to 55 years
* Females must not be pregnant or plan to become pregnant
* BMI 18 to 30 kg/m2
* Past or non-smoker
* High probability of compliance with completion of study
* Healthy as determined by investigator based on medical history, physical exam, clinical laboratory tests, vital sign measurements, ECGs
Exclusion Criteria:
* Presence or history of disorder that could interfere with completion of study
* Unstable medical condition
* Surgical or medical condition that may interfere with absorption, distribution, metabolism or excretion of test drug
* Positive Hep B, Hep C and/or HIV test
* Positive urine drug screen
* Any history of skin disorders, including psoriasis, eczema, tattoos, significant scarring, healing wounds, skin lesions on knees or elbows
* Significant disease
* Any clinically important deviation from normal limits in physical exam, vital sign measurements, 12 lead ECG, clinical laboratory test
* History of drug abuse with 1 year
* History of alcoholism with 1 year
* Use of prescription medications or ibuprofen within 30 days of Day 1, use of OTC drugs, herbal supplements and vitamins within 14 days of Day 1.
* Use of investigational drug within 30 day of Day 1
* Acute disease state within 7 days of Day 1
* Consumption of grapefruit or grapefruit containing products within 72 hours of Day 1
* Tobacco use/caffeine use within 48 hours of Day 1
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT01986660
Study Brief:
Protocol Section:
NCT01986660