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:
NCT01916850
Eligibility Criteria:
Inclusion Criteria:
* Adult subjects ≥ 18 to ≤ 55 years of age
* Vital signs at Screening in the following ranges: systolic blood pressure, 90-140 mm Hg; diastolic blood pressure, 50-90 mm Hg; heart rate, 50-100 bpm
* Body mass index (BMI) ≥18 and ≤35 kg/sq m
* Willing and able to provide written informed consent
Exclusion Criteria:
* Use of any medication (prescription, over-the-counter, herbal tea, or supplements) within 5 days of dosing
* Use of any investigational agent or study treatment within 30 days of dosing
* Use of any protein or antibody-based therapeutic agents within 3 months of Screening
* Prior exposure to LX4211
* Use of cigarettes or any tobacco products within 2 months prior to Screening and while participating in the study
* History of bariatric surgery or any other gastrointestinal surgery that may induce malabsorption
* History of any major surgery within 6 months of Screening
* History of any hypersensitivity to the inactive components of LX4211
* History of renal disease or significantly abnormal kidney function tests
* History of hepatic disease or significantly abnormal liver function tests
* History of any active infection within 14 days prior to Day 1
* History of alcohol or substance abuse within 2 years prior to Day 1
* Donation or loss of \>400 mL of blood or blood product within 3 months of dosing
* Positive urine glucose at Screening
* Positive urine screen for drugs of abuse, or urine test for alcohol at Screening or Day -1
* Inability or difficulty swallowing pills
* Unable or unwilling to communicate or cooperate with the Investigator
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT01916850
Study Brief:
Protocol Section:
NCT01916850