NCT02373046

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2015

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

February 16, 2015

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 26, 2015

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
Last Updated

October 2, 2015

Status Verified

September 1, 2015

Enrollment Period

2 months

First QC Date

February 16, 2015

Last Update Submit

September 30, 2015

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

  • AUC

    Days 1 to 5, Days 9 to 13

  • Urinary Glucose Excretion (UGE)

    Day 1, Day 9

Secondary Outcomes (1)

  • # of Adverse Events

    Day 1-Day 14

Study Arms (2)

Treatment A

EXPERIMENTAL

1 × 400-mg LX4211 tablet (fasted conditions)

Drug: LX4211

Treatment B

EXPERIMENTAL

2 × 200-mg LX4211 tablets (fasted conditions)

Drug: LX4211

Interventions

LX4211DRUG

Single dose of LX4211 400 mg as 1 × 400-mg tablet Day 1 or Day 9

Treatment ATreatment B

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lexicon Investigational Site

Dallas, Texas, 75247, United States

Location

MeSH Terms

Interventions

(2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(methylthio)tetrahydro-2H-pyran-3,4,5-triol

Study Officials

  • Suman Wason, M.D.

    Lexicon Pharmaceuticals, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 16, 2015

First Posted

February 26, 2015

Study Start

February 1, 2015

Primary Completion

April 1, 2015

Last Updated

October 2, 2015

Record last verified: 2015-09

Locations

US(1)