Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 November 24, 2014