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

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ClinicalTrials.gov Identifier: NCT01334242
Recruitment Status : Completed
First Posted : April 13, 2011
Last Update Posted : May 19, 2011
Sponsor:
Information provided by:
Lexicon Pharmaceuticals

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

Condition or disease Intervention/treatment Phase
Healthy Drug: Schedule A Drug: Schedule B Drug: Schedule C Drug: Schedule D Drug: Schedule E Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 14 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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
Study Start Date : March 2011
Actual Primary Completion Date : April 2011

Arm Intervention/treatment
Experimental: LX4211
400 mg of LX4211 administered orally
Drug: Schedule A
Dosing 1 hour before breakfast
Drug: Schedule B
Dosing 0.5 hour before breakfast
Drug: Schedule C
Dosing immediately before breakfast
Drug: Schedule D
Dosing immediately before lunch
Drug: Schedule E
Split dose, dosing 1 hour before breakfast and dinner
Placebo Comparator: Placebo
Nonidentical placebo administered orally
Drug: Schedule A
Dosing 1 hour before breakfast
Drug: Schedule B
Dosing 0.5 hour before breakfast
Drug: Schedule C
Dosing immediately before breakfast
Drug: Schedule D
Dosing immediately before lunch
Drug: Schedule E
Split dose, dosing 1 hour before breakfast and dinner



Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01334242


Locations
United States, Texas
Lexicon Investigational Site
San Antonio, Texas, United States, 78209
Sponsors and Collaborators
Lexicon Pharmaceuticals
Investigators
Study Director: Ikenna Ogbaa, MD Lexicon Pharmaceuticals, Inc.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ikenna Ogbaa, MD - Medical Director, Lexicon Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01334242     History of Changes
Other Study ID Numbers: LX4211.1-104-NRM
LX4211.104 ( Other Identifier: Lexicon Pharmaceuticals, Inc. )
First Posted: April 13, 2011    Key Record Dates
Last Update Posted: May 19, 2011
Last Verified: May 2011

Keywords provided by Lexicon Pharmaceuticals:
Pharmacodynamics