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OpenTrials
Completed

NCT Number: NCT01916863

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

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.

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Key information

Conditions

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Lexicon Investigational Site

Chula Vista, California, 91911, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LX4211 400 mg

Drug

Canagliflozin 300 mg

Drug

LX4211 Placebo

Drug

Primary outcomes

  1. Change from baseline in rate of glucose appearance after meal (RaO)

    Time frame: Days 1, 8, 15

Secondary outcomes

  1. Rate of total glucose appearance (RaT)

    Time frame: Days 1, 8, 15

  2. Change from baseline in fasting plasma glucose

    Time frame: Days 1, 8, 15

  3. Change from baseline in postprandial glucose

    Time frame: Days 1, 8, 15

  4. Change from baseline in insulin

    Time frame: Days 1, 8, 15

Sponsors and collaborators

Lead sponsor

Lexicon Pharmaceuticals

Industry

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2013
First posted
Aug 6, 2013
Registry last updated
Oct 30, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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