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 ≤35 kg/sq m
Able and willing to provide written informed consent
Nonsmoker and has not used any tobacco products for at least 3 months prior to Screening
Willing to adhere to the prohibitions and restrictions specified in this protocol
Able to tolerate prolonged periods of quiet, motionless, supervised rest
You may not be if
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 prior to Screening
Use of any protein or antibody-based therapeutic agents within 3 months prior to Screening
Prior exposure to LX4211
Daily use of cigarettes or any tobacco products within 3 months prior to Screening and while participating in the study
History of any major surgery within 6 months prior to Screening
History of any serious adverse reaction or hypersensitivity to any inactive component of LX4211
History of renal disease or significantly abnormal kidney function tests
History of hepatic disease or significantly abnormal liver function tests
Women who are breastfeeding or are planning to become pregnant during the study
History of any active infection within 14 days prior to Screening
History of alcohol or substance abuse within 2 years prior to Screening
History of hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV Ab), HIV-1 or HIV-2
Presence of clinically significant physical, laboratory, or ECG findings (eg, QTcF \>450 msec for females and QTcF \>430 msec for males) at Screening
\>30 premature ventricular beats per hour on the telemetry ECG monitoring at Day -2 of Period 1
History of additional risk factors for the presence of a family history of Short QT Syndrome, Long QT Syndrome, sudden unexplained death at a young age (\<=40 years), drowning or sudden infant death syndrome in a first degree relative (ie, biological parent, sibling, or child)
Any skin condition likely to interfere with ECG electrode placement or adhesion
Any skin condition likely to interfere with ECG electrode placement or adhesion
Donation or loss of \>400 mL of blood or blood product within 3 months prior to Screening
Positive urine glucose during Screening
Positive pregnancy test during Screening
Positive urine screen for drugs of abuse during Screening
Positive urine test for alcohol during Screening
Inability or difficulty swallowing whole tablets or capsules
Unable or unwilling to communicate or cooperate with the Investigator for any reason
Clareo Health | Study to Define the Electrocardiogram Effects of a Single Dose of LX4211 in Healthy Subjects
