Healthy
Conditions
Brief summary
The primary objective of this study is to evaluate the safety and tolerability of multiple oral doses of LX4211 400 mg and LX4211 800 mg (administered once daily for 10 consecutive days) in healthy subjects.
Interventions
Sponsors
Lexicon Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants with Adverse Events | Up to Day 10 |
Secondary
| Measure | Time frame |
|---|---|
| Area under the curve | Days 1 through 10 |
Countries
United States
Outcome results
None listed