Status:
COMPLETED
Study to Evaluate the Effect of Single Doses of LX4211 and Canagliflozin on Intestinal Glucose Absorption in Healthy Adult Subjects
Lead Sponsor:
Lexicon Pharmaceuticals
Conditions:
Healthy Subjects
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief 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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT01916863
Start Date
August 1 2013
Last Update
October 30 2013
Active Locations (1)
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1
Lexicon Investigational Site
Chula Vista, California, United States, 91911