NCT01913002

Brief Summary

This Phase 1 study is to investigate the effects of higher doses of LX4211 (800 mg and 2000 mg) do not differ from placebo in the mean change in QTcI from Baseline in healthy subjects.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
63

participants targeted

Target at P75+ 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

July 1, 2013

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

July 29, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 31, 2013

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
Last Updated

October 30, 2013

Status Verified

October 1, 2013

Enrollment Period

3 months

First QC Date

July 29, 2013

Last Update Submit

October 28, 2013

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in QTc intervals

    Day -1, Day 1 of each period (2, 3, 4)

Secondary Outcomes (2)

  • Number of subjects experiencing an adverse event

    up to 87 days

  • Plasma concentrations of LX4211

    Day 1 of each Period: predose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, and 60 hours after dosing time on Day 1 hours

Study Arms (4)

Treatment A

EXPERIMENTAL

LX4211 800 mg

Drug: LX4211 800 mgDrug: LX4211 2000 mgDrug: moxifloxacin 400 mgDrug: LX4211 Placebo

Treatment B

EXPERIMENTAL

LX4211 2000 mg

Drug: LX4211 800 mgDrug: LX4211 2000 mgDrug: moxifloxacin 400 mgDrug: LX4211 Placebo

Treatment C

ACTIVE COMPARATOR

moxifloxacin 400 mg

Drug: LX4211 800 mgDrug: LX4211 2000 mgDrug: moxifloxacin 400 mgDrug: LX4211 Placebo

Treatment D

PLACEBO COMPARATOR

Placebo

Drug: LX4211 800 mgDrug: LX4211 2000 mgDrug: moxifloxacin 400 mgDrug: LX4211 Placebo

Interventions

LX4211 800 mgDRUG
Treatment ATreatment BTreatment CTreatment D
LX4211 2000 mgDRUG
Treatment ATreatment BTreatment CTreatment D
moxifloxacin 400 mgDRUG
Treatment ATreatment BTreatment CTreatment D
LX4211 PlaceboDRUG
Treatment ATreatment BTreatment CTreatment D

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
  • Vital signs at Screening in the following ranges: systolic blood pressure, 90-140 mmHg; diastolic blood pressure, 50-90 mmHg; heart rate, 45-100 bpm
  • Body mass index (BMI) ≥18 and ≤35 kg/sq m
  • Able and willing to provide written informed consent
  • Nonsmoker and has not used any tobacco products for at least 3 months prior to Screening
  • Willing to adhere to the prohibitions and restrictions specified in this protocol
  • Able to tolerate prolonged periods of quiet, motionless, supervised rest

You may not qualify if:

  • 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 prior to Screening
  • Use of any protein or antibody-based therapeutic agents within 3 months prior to Screening
  • Prior exposure to LX4211
  • Daily use of cigarettes or any tobacco products within 3 months prior to Screening and while participating in the study
  • History of any major surgery within 6 months prior to Screening
  • History of any serious adverse reaction or hypersensitivity to any inactive component of LX4211
  • History of renal disease or significantly abnormal kidney function tests
  • History of hepatic disease or significantly abnormal liver function tests
  • Women who are breastfeeding or are planning to become pregnant during the study
  • History of any active infection within 14 days prior to Screening
  • History of alcohol or substance abuse within 2 years prior to Screening
  • History of hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV Ab), HIV-1 or HIV-2
  • Presence of clinically significant physical, laboratory, or ECG findings (eg, QTcF \>450 msec for females and QTcF \>430 msec for males) at Screening
  • \>30 premature ventricular beats per hour on the telemetry ECG monitoring at Day -2 of Period 1
  • +10 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lexicon Investigational Site

Austin, Texas, 78744, 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-triolMoxifloxacin

Intervention Hierarchy (Ancestors)

Fluoroquinolones4-QuinolonesQuinolonesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Ikenna (Ike) Ogbaa, M.D.

    Lexicon Pharmaceuticals, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 29, 2013

First Posted

July 31, 2013

Study Start

July 1, 2013

Primary Completion

October 1, 2013

Last Updated

October 30, 2013

Record last verified: 2013-10

Locations

US(1)