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 @ 10:02 PM
Ignite Modification Date:
2025-12-24 @ 10:02 PM
NCT ID:
NCT01818232
Eligibility Criteria:
Inclusion Criteria:
* Adults ≥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
* Historically able to produce a minimum of 1 bowel movement per day
* Willing and able to provide written informed consent
Exclusion Criteria:
* Female
* Receipt of any investigational drug within 30 days prior to Dosing, or investigational protein or antibody-based therapeutic agents within 3 months prior to Screening
* Prior exposure to LX4211
* Use any tobacco product within 2 months prior to Screening and while participating in the study (Day -1 through Discharge)
* History of bariatric surgery or any other GI surgery that may induce malabsorption
* History of any major surgery within 6 months prior to Screening
* History of renal or hepatic disease, or significantly abnormal kidney or liver function tests at Screening
* History of any clinically relevant psychiatric, renal, hepatic, pancreatic, cardiovascular, neurological, hematological, or GI abnormality
* History of any active infection within 14 days prior to Dosing
* History of alcohol or substance abuse within 2 years prior to Dosing
* History of human immunodeficiency virus (HIV), hepatitis B, or hepatitis C
* 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 at Screening or Day -1
* Positive breath test for alcohol at Screening or Day -1
* Participation in \>1 other radiolabeled investigational study drug trial within 12 months prior to Day -1
* Exposure to significant radiation within 12 months prior to Day -1
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT01818232
Study Brief:
Protocol Section:
NCT01818232