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 @ 3:56 AM
Ignite Modification Date:
2025-12-25 @ 3:56 AM
NCT ID:
NCT03826602
Eligibility Criteria:
Inclusion Criteria:
* Healthy status, as defined by the absence of evidence of any clinically significant findings
* Males must agree to use a barrier method of birth control and not donate sperm during study plus 30 days after last dose of study drug
* Weight of ≥60kg
* Body mass index between 18.0 and 32.0 kg/m² (inclusive)
* Ability to abstain from alcohol-, caffeine-, and xanthine-containing food and beverages from 48 hours prior to admission through study discharge
* All nonregular medication (including over-the-counter medication, health supplements, and herbal remedies) must be stopped at least 28 days prior to admission
Exclusion Criteria:
* Females who are of childbearing potential or lactating
* Males with female partners who are pregnant, lactating, or planning to become pregnant within 30 days of the study
* Use of any investigational drug or device within 30 days of study start
* Use of tobacco products within 21 days prior to admission
* Routine or chronic use of more than 3 grams of acetaminophen daily
* Strenuous activity, sunbathing, and contact sports within 72 hours prior to first admission and for the duration of the study
* Blood transfusion within 90 days of study drug administration
* History of alcoholism or drug abuse within 2 years
* History of alcohol consumption exceeding 7 drinks/week for female participants or 14 drinks/week for male subjects
* History of donation of more than 450 mL of blood within 60 days prior to dosing, or planned donation before 30 days have elapsed since intake of study drug
* Plasma or platelet donation within 7 days of initial study drug administration
* Positive screening test for Hepatitis B, Hepatitis C, or HIV 1 or 2 (human immunodeficiency virus)
* Acute or chronic metabolic acidosis, including diabetic ketoacidosis
* Renal disease or dysfunction as suggested by serum creatinine levels or abnormal creatinine clearance
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT03826602
Study Brief:
Protocol Section:
NCT03826602