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 @ 1:08 AM
Ignite Modification Date:
2025-12-25 @ 1:08 AM
NCT ID:
NCT01292993
Eligibility Criteria:
Inclusion Criteria:
* Adults ≥18 to ≤55 years of age. Females must be of non-childbearing potential.
* Body mass index (BMI)≥18 to ≤35 kg/sq m
* Able to provide written consent
* Vital signs within sponsor-defined ranges
Exclusion Criteria:
* Use of any medication, including any prescription, over-the-counter, herbal tea, or other supplements within 5 days of dosing
* No investigational agent or study treatment within 30 days prior to Day 1.
* No protein or antibody-based therapeutic agents within 3 months prior to screening
* Use of any tobacco product
* History of bariatric surgery or any gastrointestinal surgery that may induce malabsorption
* History of any major surgery within 6 months prior to screening
* History of any serious adverse reaction or hypersensitivity to metformin or LX4211.
* History of renal disease or significantly abnormal kidney function test
* History of hepatic disease or significantly abnormal liver function test
* History of any active infection within 30 days prior to Day 1
* History of any surgical or medical condition or clinically significant laboratory or physical finding
* Positive urine glucose at Screening
* Use of drugs or alcohol
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT01292993
Study Brief:
Protocol Section:
NCT01292993