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 @ 5:05 PM
Ignite Modification Date:
2025-12-24 @ 5:05 PM
NCT ID:
NCT02243150
Eligibility Criteria:
Inclusion Criteria:
* Healthy male and female volunteers, 18-60 years of age; no clinically significant findings reported following detailed physical examination, medical history, vital signs, clinical laboratory tests, and ECGs as deemed by the PI
* Body mass index (BMI) in the range of 18 to 32 kg/m2 (inclusive) and weighing at least 50 kg
* Non-smokers / non-users of nicotine containing products for at least the previous 3 months
* Agreement to use birth control during the study and 3 months post last visit
* Able to comply with all protocol requirements and procedures
Exclusion Criteria:
* Clinically significant abnormalities found during physical examination, medical history review, ECGs (including QTcf interval \> 450 msec), vital signs and laboratory tests (including positive test for HIV, hepatitis B and/or C)
* History of any serious allergic reaction to any medication
* Participated in a previous clinical trial with an investigational product in the last 60 days
* Any blood or plasma donation or other loss of blood at a volume exceeding 500 mL within 3 months before dosing
* History of drug or alcohol abuse in the last 2 years and positive test for drug abuse
* Use of any systemic medication within the past 2 weeks, including use of herbal products
* Pregnant or lactating women
* Any other issue which, in the opinion of the PI, will make the subject ineligible for study participation
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT02243150
Study Brief:
Protocol Section:
NCT02243150