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Completed

NCT Number: NCT01334242

A Study to Determine the Pharmacodynamics of LX4211 Relative to Meals in Healthy Subjects

The primary purpose of this study is to evaluate the pharmacodynamics of LX4211 relative to meals in healthy subjects.

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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

San Antonio, Texas, 78209, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Adults ≥18 and ≤55 years of age
  • Vital signs at Screening in the following ranges: systolic blood pressure, 90-140 mm Hg; diastolic blood pressure, 50-90 mm Hg; heart rate, 50-100 bpm
  • Body mass index (BMI) ≥18 and ≤35 kg/sq m
  • Able to provide written informed consent

Exclusion criteria

  • Use of any medication (prescription, over-the-counter, herbal tea, or supplements) within 5 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 any SGLT inhibitor
  • Use of 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 any major surgery within 6 months of Screening
  • History of any hypersensitivity to the inactive components of LX4211
  • 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 of Day 1
  • History of alcohol or substance abuse within 2 years prior to Day 1
  • Positive urine glucose at Screening
  • Positive pregnancy test at Screening
  • Inability or difficulty swallowing whole tablets or capsules
  • Unable or unwilling to communicate or cooperate with the Investigator.

Treatment and study plan

Schedule A

Drug

Dosing 1 hour before breakfast

Schedule B

Drug

Dosing 0.5 hour before breakfast

Schedule C

Drug

Dosing immediately before breakfast

Schedule D

Drug

Dosing immediately before lunch

Schedule E

Drug

Split dose, dosing 1 hour before breakfast and dinner

Primary outcomes

  1. Urinary glucose excretion

    Time frame: 24 hours collection on Day -1 and Days 7-13

  2. Fasting Plasma Glucose

    Time frame: Day -1 and Days 7-12

  3. Postprandial Glucose

    Time frame: Day -1 and Days 7-12

  4. Insulin

    Time frame: Day -1 and Days 7-12

  5. Glucagon-like peptide 1 (total and active)

    Time frame: Day -1 and Days 7-12

  6. Peptide YY

    Time frame: Day -1 and Days 7-12

Secondary outcomes

  1. Number of Participants with Adverse Events

    Time frame: Day 1 to Day 14

  2. Blood chemistry

    Time frame: Day -2, Day 7 and Day 13

    Including albumin, ALP, ALT, AST, total bilirubin, glucose, BUN, calcium, carbon dioxide, chloride, cholesterol and triglycerides, creatinine, magnesium, phosphorus, potassium, sodium, protein, and uric acid.

  3. Hematology

    Time frame: Day -2, Day 7 and Day 13

    Including complete blood count with differential, hemoglobin, hematocrit, lymphocyte, and platelet counts.

Sponsors and collaborators

Lead sponsor

Lexicon Pharmaceuticals

Industry

Registry information

Official study title

A Phase 1, Single-Center, Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose Study to Determine the Pharmacodynamics of LX4211 Relative to Meals in Healthy Subjects

Important dates

Study start
2011
Primary completion
2011
First posted
Apr 13, 2011
Registry last updated
May 19, 2011

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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