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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Lexicon Pharmaceuticals
• Treatments: (2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(methylthio)tetrahydro-2H-pyran-3,4,5-triol; Canagliflozin

Criteria

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 malabsorption

• 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