Expired Study
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San Antonio, Texas 78209


Purpose:

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


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.


Study is Available At:


Original ID:

LX4211.1-104-NRM


NCT ID:

NCT01334242


Secondary ID:

LX4211.104


Study Acronym:


Brief Title:

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


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


Overall Status:

Completed


Study Phase:

Phase 1


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

55 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Lexicon Pharmaceuticals


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

14


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Ikenna Ogbaa, MD
Study Director
Lexicon Pharmaceuticals, Inc.

Study Dates

Start Date:March 2011
Primary Completion Date:April 2011
Primary Completion Type:Actual
Verification Date:May 2011
Last Changed Date:May 18, 2011
First Received Date:April 6, 2011

Study Outcomes

Outcome Type:Primary Outcome
Measure:Urinary glucose excretion
Time Frame:24 hours collection on Day -1 and Days 7-13
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Fasting Plasma Glucose
Time Frame:Day -1 and Days 7-12
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Postprandial Glucose
Time Frame:Day -1 and Days 7-12
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Insulin
Time Frame:Day -1 and Days 7-12
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Glucagon-like peptide 1 (total and active)
Time Frame:Day -1 and Days 7-12
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Peptide YY
Time Frame:Day -1 and Days 7-12
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Number of Participants with Adverse Events
Time Frame:Day 1 to Day 14
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Blood chemistry
Time Frame:Day -2, Day 7 and Day 13
Safety Issues:False
Description: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.
Outcome Type:Secondary Outcome
Measure:Hematology
Time Frame:Day -2, Day 7 and Day 13
Safety Issues:False
Description:Including complete blood count with differential, hemoglobin, hematocrit, lymphocyte, and platelet counts.

Study Interventions

Intervention Type:Drug
Name:Schedule A
Description:Dosing 1 hour before breakfast
Arm Name:LX4211
Intervention Type:Drug
Name:Schedule B
Description:Dosing 0.5 hour before breakfast
Arm Name:LX4211
Intervention Type:Drug
Name:Schedule C
Description:Dosing immediately before breakfast
Arm Name:LX4211
Intervention Type:Drug
Name:Schedule D
Description:Dosing immediately before lunch
Arm Name:LX4211
Intervention Type:Drug
Name:Schedule E
Description:Split dose, dosing 1 hour before breakfast and dinner
Arm Name:LX4211

Study Arms

Study Arm Type:Experimental
Arm Name:LX4211
Description:400 mg of LX4211 administered orally
Study Arm Type:Placebo Comparator
Arm Name:Placebo
Description:Nonidentical placebo administered orally

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Lexicon Pharmaceuticals

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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