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Bioequivalence Study Between 400 mg LX4211 Tablets and 2 X 200 mg LX4211 Tablets

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02373046
Recruitment Status : Completed
First Posted : February 26, 2015
Last Update Posted : October 2, 2015
Sponsor:
Information provided by (Responsible Party):
Lexicon Pharmaceuticals

Brief Summary:
This is a randomized, single-center, open-label, 2-sequence, 2-period, single-dose, crossover study to assess the bioequivalence and the total 24-hour urinary glucose excretion (UGE) of 400 mg LX4211 administered as a single 400-mg tablet compared to 2 × 200-mg tablets in healthy subjects under fasted conditions.

Condition or disease Intervention/treatment Phase
Healthy Drug: LX4211 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1, Randomized, Single-center, Open-label, 2-sequence, 2-period, Single-dose Crossover Study to Evaluate Bioequivalence (Pharmacokinetics) and to Compare Total 24-hour Urinary Glucose Excretion (Pharmacodynamics) When 400 mg LX4211 is Administered as a Single 400-mg Tablet and 2 × 200-mg Tablets in Healthy Male and Female Subjects
Study Start Date : February 2015
Actual Primary Completion Date : April 2015

Arm Intervention/treatment
Experimental: Treatment A
1 × 400-mg LX4211 tablet (fasted conditions)
Drug: LX4211
Single dose of LX4211 400 mg as 1 × 400-mg tablet Day 1 or Day 9

Drug: LX4211
Single dose of LX4211 400 mg as 2 × 200-mg tablets on Day 1 or Day 9

Experimental: Treatment B
2 × 200-mg LX4211 tablets (fasted conditions)
Drug: LX4211
Single dose of LX4211 400 mg as 1 × 400-mg tablet Day 1 or Day 9

Drug: LX4211
Single dose of LX4211 400 mg as 2 × 200-mg tablets on Day 1 or Day 9




Primary Outcome Measures :
  1. AUC [ Time Frame: Days 1 to 5, Days 9 to 13 ]
  2. Urinary Glucose Excretion (UGE) [ Time Frame: Day 1, Day 9 ]

Secondary Outcome Measures :
  1. # of Adverse Events [ Time Frame: Day 1-Day 14 ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


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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:

  • Adult subjects ≥18 to ≤55 years of age
  • Willing and able to provide written informed consent

Exclusion Criteria:

  • Presence of clinically significant physical, laboratory, or ECG findings that, in the opinion of the Investigator and/or Sponsor, may interfere with any aspect of study conduct or interpretation of results
  • Existence of any surgical or medical condition that might interfere with the absorption, distribution, metabolism, or excretion of LX4211
  • History of renal disease, or significantly abnormal kidney function test at Screening
  • History of hepatic disease, or significantly abnormal liver function tests at Screening
  • History of any clinically relevant psychiatric, renal, hepatic, pancreatic, endocrine, cardiovascular, neurological, hematological, or GI abnormality

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): NCT02373046


Locations
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United States, Texas
Lexicon Investigational Site
Dallas, Texas, United States, 75247
Sponsors and Collaborators
Lexicon Pharmaceuticals
Investigators
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Study Director: Suman Wason, M.D. Lexicon Pharmaceuticals, Inc.
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Responsible Party: Lexicon Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02373046    
Other Study ID Numbers: LX4211.1-117-NRM
LX4211.117 ( Other Identifier: Lexicon Pharmaceuticals, Inc. )
First Posted: February 26, 2015    Key Record Dates
Last Update Posted: October 2, 2015
Last Verified: September 2015
Additional relevant MeSH terms:
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(2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(methylthio)tetrahydro-2H-pyran-3,4,5-triol
Sodium-Glucose Transporter 2 Inhibitors
Molecular Mechanisms of Pharmacological Action
Hypoglycemic Agents
Physiological Effects of Drugs