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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

Tracking Information
First Submitted Date  ICMJE April 6, 2011
First Posted Date  ICMJE April 13, 2011
Last Update Posted Date May 19, 2011
Study Start Date  ICMJE March 2011
Actual Primary Completion Date April 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 11, 2011)
  • Urinary glucose excretion [ Time Frame: 24 hours collection on Day -1 and Days 7-13 ]
  • Fasting Plasma Glucose [ Time Frame: Day -1 and Days 7-12 ]
  • Postprandial Glucose [ Time Frame: Day -1 and Days 7-12 ]
  • Insulin [ Time Frame: Day -1 and Days 7-12 ]
  • Glucagon-like peptide 1 (total and active) [ Time Frame: Day -1 and Days 7-12 ]
  • Peptide YY [ Time Frame: Day -1 and Days 7-12 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01334242 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 11, 2011)
  • Number of Participants with Adverse Events [ Time Frame: Day 1 to Day 14 ]
  • 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.
  • Hematology [ Time Frame: Day -2, Day 7 and Day 13 ]
    Including complete blood count with differential, hemoglobin, hematocrit, lymphocyte, and platelet counts.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Determine the Pharmacodynamics of LX4211 Relative to Meals in Healthy Subjects
Official Title  ICMJE 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
Brief Summary The primary purpose of this study is to evaluate the pharmacodynamics of LX4211 relative to meals in healthy subjects.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Healthy
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: LX4211
    400 mg of LX4211 administered orally
    Interventions:
    • Drug: Schedule A
    • Drug: Schedule B
    • Drug: Schedule C
    • Drug: Schedule D
    • Drug: Schedule E
  • Placebo Comparator: Placebo
    Nonidentical placebo administered orally
    Interventions:
    • Drug: Schedule A
    • Drug: Schedule B
    • Drug: Schedule C
    • Drug: Schedule D
    • Drug: Schedule E
Publications * Zambrowicz B, Ogbaa I, Frazier K, Banks P, Turnage A, Freiman J, Boehm KA, Ruff D, Powell D, Sands A. Effects of LX4211, a dual sodium-dependent glucose cotransporters 1 and 2 inhibitor, on postprandial glucose, insulin, glucagon-like peptide 1, and peptide tyrosine tyrosine in a dose-timing study in healthy subjects. Clin Ther. 2013 Aug;35(8):1162-1173.e8. doi: 10.1016/j.clinthera.2013.06.011. Epub 2013 Jul 31.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: April 11, 2011)
14
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date April 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01334242
Other Study ID Numbers  ICMJE LX4211.1-104-NRM
LX4211.104 ( Other Identifier: Lexicon Pharmaceuticals, Inc. )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ikenna Ogbaa, MD - Medical Director, Lexicon Pharmaceuticals, Inc.
Study Sponsor  ICMJE Lexicon Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Ikenna Ogbaa, MD Lexicon Pharmaceuticals, Inc.
PRS Account Lexicon Pharmaceuticals
Verification Date May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP