Study to Evaluate the Effect of Single Doses of LX4211 and Canagliflozin on Intestinal Glucose Absorption in Healthy Adult Subjects

Conditions:Healthy Studies
Therapuetic Areas:Other
Age Range:18 - 55
Start Date:August 2013
Contact:Anne Turnage

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A Phase 1, Single-center, Partially Double-blind, Randomized, Single-dose, 3-Period Crossover Study to Assess the Pharmacodynamic Effects of LX4211 and INVOKANA™ (Canagliflozin) in Healthy Subjects Using Stable Isotope Tracer Methods

The purpose of this study is to assess the effect of LX4211 and the comparator drug
canagliflozin on intestinal glucose absorption and metabolism after a single dose in healthy
subjects in comparison to placebo.

Inclusion Criteria:

- 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

- Willing and able to provide written informed consent

Exclusion Criteria:

- Use of any medication (prescription, over-the-counter, herbal tea, or supplements)
within 7 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 LX4211 or canagliflozin

- Daily use of >5 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

- History of bowel resection, any malabsorptive disorder, severe gastroparesis, any GI
procedure for the purpose of weight loss which would slow gastric emptying

- History of any major surgery within 6 months prior to Screening

- History of any hypersensitivity to the inactive components of LX4211, inactive
components of canagliflozin, acetaminophen oral solution or any inactive component of
acetaminophen liquid preparation

- 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 prior to Day -1

- History of alcohol or substance abuse within 2 years prior to Day 1

- History of hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV Ab), HIV-1
or HIV-2

- Donation or loss of >500 mL of blood or blood product within 56 days of Day -1

- positive pregnancy test at Screening or Day -1

- Positive urine screen for drugs of abuse at Screening or Day -1

- Positive breath test for alcohol at Screening or Day -1

- Inability or difficulty swallowing whole tablets

- Unable or unwilling to communicate or cooperate with the Investigator
We found this trial at
Anaheim, California 92801
Anaheim, CA
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