A Study to Determine the Pharmacodynamics of LX4211 Relative to Meals in Healthy Subjects
Phase 1
Completed
- Conditions
- Healthy
- Interventions
- Registration Number
- NCT01334242
- Lead Sponsor
- Lexicon Pharmaceuticals
- Brief Summary
The primary purpose of this study is to evaluate the pharmacodynamics of LX4211 relative to meals in healthy subjects.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 14
Inclusion Criteria
- Adults ≥18 and ≤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
- 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 Day 1
- Use of any protein or antibody-based therapeutic agents within 3 months of Screening
- Prior exposure to any SGLT inhibitor
- Use of cigarettes or any tobacco products within 6 weeks 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 30 days of Day 1
- History of alcohol or substance abuse within 2 years prior to Day 1
- Positive urine glucose at Screening
- Positive pregnancy test at Screening
- Inability or difficulty swallowing whole tablets or capsules
- Unable or unwilling to communicate or cooperate with the Investigator.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description LX4211 Schedule D 400 mg of LX4211 administered orally LX4211 Schedule A 400 mg of LX4211 administered orally LX4211 Schedule B 400 mg of LX4211 administered orally LX4211 Schedule C 400 mg of LX4211 administered orally LX4211 Schedule E 400 mg of LX4211 administered orally Placebo Schedule A Nonidentical placebo administered orally Placebo Schedule B Nonidentical placebo administered orally Placebo Schedule C Nonidentical placebo administered orally Placebo Schedule D Nonidentical placebo administered orally Placebo Schedule E Nonidentical placebo administered orally
- Primary Outcome Measures
Name Time Method Urinary glucose excretion 24 hours collection on Day -1 and Days 7-13 Fasting Plasma Glucose Day -1 and Days 7-12 Postprandial Glucose Day -1 and Days 7-12 Insulin Day -1 and Days 7-12 Glucagon-like peptide 1 (total and active) Day -1 and Days 7-12 Peptide YY Day -1 and Days 7-12
- Secondary Outcome Measures
Name Time Method Number of Participants with Adverse Events Day 1 to Day 14 Blood chemistry Day -2, Day 7 and Day 13 Including albumin, ALP, ALT, AST, total bilirubin, glucose, BUN, calcium, carbon dioxide, chloride, cholesterol and triglycerides, creatinine, magnesium, phosphorus, potassium, sodium, protein, and uric acid.
Hematology Day -2, Day 7 and Day 13 Including complete blood count with differential, hemoglobin, hematocrit, lymphocyte, and platelet counts.
Trial Locations
- Locations (1)
Lexicon Investigational Site
🇺🇸San Antonio, Texas, United States