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

September 30, 2015 updated by: Lexicon Pharmaceuticals

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Dallas, Texas, United States, 75247
        • Lexicon Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
AUC
Time Frame: Days 1 to 5, Days 9 to 13
Days 1 to 5, Days 9 to 13
Urinary Glucose Excretion (UGE)
Time Frame: Day 1, Day 9
Day 1, Day 9

Secondary Outcome Measures

Outcome Measure
Time Frame
# of Adverse Events
Time Frame: Day 1-Day 14
Day 1-Day 14

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lexicon Pharmaceuticals

Investigators

  • Study Director: Suman Wason, M.D., Lexicon Pharmaceuticals, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2015

Primary Completion (Actual)

April 1, 2015

Study Registration Dates

First Submitted

February 16, 2015

First Submitted That Met QC Criteria

February 20, 2015

First Posted (Estimate)

February 26, 2015

Study Record Updates

Last Update Posted (Estimate)

October 2, 2015

Last Update Submitted That Met QC Criteria

September 30, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LX4211.1-117-NRM
  • LX4211.117 (Other Identifier: Lexicon Pharmaceuticals, Inc.)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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