Study to Determine the Safety, Tolerability and Pharmacokinetics Following Multiple Doses of LX4211 in Healthy Subjects



Status:Not yet recruiting
Conditions:Healthy Studies
Therapuetic Areas:Other
Healthy:No
Age Range:18 - 55
Updated:10/19/2013
Start Date:August 2013
Contact:Lisa Sherman
Email:lsherman@lexpharma.com
Phone:(281) 863-3228

Use our guide to learn which trials are right for you!

A Phase 1b, Single-center, Double-blind, Randomized, Placebo-controlled Study on the Safety, Tolerability, and Pharmacokinetic Effects of Multiple Doses of LX4211 400 mg qd and LX4211 800 mg qd in Healthy Subjects


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.


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
We found this trial at
1
site
San Antonio, Texas 78209
?
mi
from
San Antonio, TX
Click here to add this to my saved trials