Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Lexicon Pharmaceuticals
Age
18–55
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
Adult subjects ≥18 to ≤55 years of age
Vital signs at Screening in the following ranges: systolic blood pressure, 90-140 mmHg; diastolic blood pressure, 50-90 mmHg; heart rate, 45-100 bpm
Body mass index (BMI) ≥18 and ≤32 kg/sq m
Willing and able to provide written informed consent
You may not be if
Presence of clinically significant physical, laboratory, or ECG findings that, in the opinion of the Investigator and/or Sponsor, may interfere with any aspect of study conduct or interpretation of results
Use of any medications or supplements/supratherapeutic doses of vitamins within 14 days prior to the first dose administration and throughout the duration of the study
Receipt of any investigational agent or study drug within 30 days prior to Screening
Receipt of any protein- or antibody-based therapeutic agents within 3 months prior to Screening
Prior exposure to LX4211
Use of tobacco, smoking cessation products, or products containing nicotine within 3 months prior to Screening and for the duration of the study
History of any serious adverse reaction or hypersensitivity to any inactive component of LX4211 or rosuvastatin
Existence of any surgical or medical condition that might interfere with the absorption, distribution, metabolism, or excretion of LX4211 or rosuvastatin
History of any major surgery within 6 months or anticipated surgery prior to Day
History of any clinically significant hypoglycemia or hyperglycemia
History of renal disease, or significantly abnormal kidney function test at Screening
History of hepatic disease, or significantly abnormal liver function tests at Screening
History of any clinically relevant psychiatric, renal, hepatic, pancreatic, endocrine, cardiovascular, neurological, hematological, or GI abnormality
History of any active infection within 14 days prior to Day 1
History of alcohol or substance abuse within 2 years prior to Screening
Positive hepatitis panel
Donation or loss of \>500 mL of blood or blood product within 3 months prior to Screening
Women who are breastfeeding or are planning to become pregnant during the study, or women who have a positive serum pregnancy test
Positive urine glucose at Screening
Positive urine screen for drugs of abuse and cotinine at Screening, Day -1, or Day 13
Inability or difficulty swallowing whole tablets
Unable or unwilling to cooperate with the Investigator for any reason
Clareo Health | DDI Study With Multiple-dose LX4211 and Single Dose Rosuvastatin
