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 @ 12:08 AM
Ignite Modification Date:
2025-12-25 @ 12:08 AM
NCT ID:
NCT02646358
Eligibility Criteria:
Key Inclusion Criteria:
* Subject must weigh ≤ 125 kg and have a body mass index between 20 and 40 kg/m2
* Subject must be willing to be confined in the clinical research unit for the duration of the study, up to 5 days
* If female, subject must not be pregnant or lactating, have a negative pregnancy test, and agrees to sexual abstinence, or use of an appropriate birth control method from screening through 30 days after study drug administration
* If male, subject agrees to sexual abstinence, is surgically sterile, or is using an appropriate birth control method from screening through 30 days after study drug administration
* Considered by the Investigator to be healthy or clinically stable with respect to underlying renal impairment based on medical evaluation including vital signs, ECG and laboratory test results
* Non-smoker, or smokes fewer than 10 cigarettes/day
Key Exclusion Criteria
* Uncontrolled medical condition (treated or untreated) considered to be clinically significant by the Investigator
* Experienced an illness considered by the Investigator to be clinically significant within 2 weeks of study drug administration
* Treatment with another investigational drug or device study within 30 days or 5 half-lives (whichever is longer) prior to screening
* Positive test for drugs of abuse and/or positive alcohol test at Screening or Day -1
* Donated or lost a significant volume of blood or plasma within 90 days prior to study drug administration
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT02646358
Study Brief:
Protocol Section:
NCT02646358