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

Lexicon Pharmaceuticals1 site in 1 country25 target enrollmentAugust 2013

ConditionsHealthy Subjects

InterventionsLX4211 400 mg canagliflozin 300 mg LX4211 Placebo

DrugsLX4211 400 mg canagliflozin 300 mg LX4211 Placebo

Overview

Phase: Phase 1
Intervention: LX4211 400 mg
Conditions: Healthy Subjects
Sponsor: Lexicon Pharmaceuticals
Enrollment: 25
Locations: 1
Primary Endpoint: Change from baseline in rate of glucose appearance after meal (RaO)
Status: Completed
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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 to placebo.

Registry

clinicaltrials.gov

Start Date

August 2013

End Date

October 2013

Last Updated

12 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Lexicon Pharmaceuticals

Responsible Party

Sponsor

Eligibility 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