Study to Evaluate the Effect of Single Doses of LX4211 and Canagliflozin on Intestinal Glucose Absorption in Healthy Adult Subjects
NCT ID: NCT01916863
Last Updated: 2013-10-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
25 participants
INTERVENTIONAL
2013-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
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LX4211
400 mg of LX4211
LX4211 400 mg
canagliflozin 300 mg
LX4211 Placebo
Canagliflozin
300 mg canagliflozin
LX4211 400 mg
canagliflozin 300 mg
LX4211 Placebo
Placebo
LX4211 placebo
LX4211 400 mg
canagliflozin 300 mg
LX4211 Placebo
Interventions
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LX4211 400 mg
canagliflozin 300 mg
LX4211 Placebo
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
55 Years
ALL
Yes
Sponsors
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Lexicon Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Paul Strumph, M.D.
Role: STUDY_DIRECTOR
Lexicon Pharmaceuticals, Inc.
Locations
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Lexicon Investigational Site
Chula Vista, California, United States
Countries
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References
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Powell DR, Zambrowicz B, Morrow L, Beysen C, Hompesch M, Turner S, Hellerstein M, Banks P, Strumph P, Lapuerta P. Sotagliflozin Decreases Postprandial Glucose and Insulin Concentrations by Delaying Intestinal Glucose Absorption. J Clin Endocrinol Metab. 2020 Apr 1;105(4):e1235-49. doi: 10.1210/clinem/dgz258.
Other Identifiers
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LX4211.111
Identifier Type: OTHER
Identifier Source: secondary_id
LX4211.1-111-NRM
Identifier Type: -
Identifier Source: org_study_id