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

This study has been completed.
Sponsor:
Information provided by:
Lexicon Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01334242
First received: April 6, 2011
Last updated: May 18, 2011
Last verified: May 2011
  Purpose

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


Condition Intervention Phase
Healthy
Drug: Schedule A
Drug: Schedule B
Drug: Schedule C
Drug: Schedule D
Drug: Schedule E
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Lexicon Pharmaceuticals:

Primary Outcome Measures:
  • Urinary glucose excretion [ Time Frame: 24 hours collection on Day -1 and Days 7-13 ] [ Designated as safety issue: No ]
  • Fasting Plasma Glucose [ Time Frame: Day -1 and Days 7-12 ] [ Designated as safety issue: No ]
  • Postprandial Glucose [ Time Frame: Day -1 and Days 7-12 ] [ Designated as safety issue: No ]
  • Insulin [ Time Frame: Day -1 and Days 7-12 ] [ Designated as safety issue: No ]
  • Glucagon-like peptide 1 (total and active) [ Time Frame: Day -1 and Days 7-12 ] [ Designated as safety issue: No ]
  • Peptide YY [ Time Frame: Day -1 and Days 7-12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of Participants with Adverse Events [ Time Frame: Day 1 to Day 14 ] [ Designated as safety issue: No ]
  • Blood chemistry [ Time Frame: Day -2, Day 7 and Day 13 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Including complete blood count with differential, hemoglobin, hematocrit, lymphocyte, and platelet counts.


Estimated Enrollment: 14
Study Start Date: March 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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.
  More Information

No publications provided by Lexicon Pharmaceuticals

Additional 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
Study First Received: April 6, 2011
Last Updated: May 18, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Lexicon Pharmaceuticals:
Pharmacodynamics

ClinicalTrials.gov processed this record on April 15, 2014