Study to Define the Electrocardiogram Effects of a Single Dose of LX4211 in Healthy Subjects
NCT ID: NCT01913002
Last Updated: 2013-10-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
63 participants
INTERVENTIONAL
2013-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
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Treatment A
LX4211 800 mg
LX4211 800 mg
LX4211 2000 mg
moxifloxacin 400 mg
LX4211 Placebo
Treatment B
LX4211 2000 mg
LX4211 800 mg
LX4211 2000 mg
moxifloxacin 400 mg
LX4211 Placebo
Treatment C
moxifloxacin 400 mg
LX4211 800 mg
LX4211 2000 mg
moxifloxacin 400 mg
LX4211 Placebo
Treatment D
Placebo
LX4211 800 mg
LX4211 2000 mg
moxifloxacin 400 mg
LX4211 Placebo
Interventions
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LX4211 800 mg
LX4211 2000 mg
moxifloxacin 400 mg
LX4211 Placebo
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
* History of additional risk factors for the presence of a family history of Short QT Syndrome, Long QT Syndrome, sudden unexplained death at a young age (\<=40 years), drowning or sudden infant death syndrome in a first degree relative (ie, biological parent, sibling, or child)
* Any skin condition likely to interfere with ECG electrode placement or adhesion
* Any skin condition likely to interfere with ECG electrode placement or adhesion
* Donation or loss of \>400 mL of blood or blood product within 3 months prior to Screening
* Positive urine glucose during Screening
* Positive pregnancy test during Screening
* Positive urine screen for drugs of abuse during Screening
* Positive urine test for alcohol during Screening
* Inability or difficulty swallowing whole tablets or capsules
* Unable or unwilling to communicate or cooperate with the Investigator for any reason
18 Years
55 Years
ALL
Yes
Sponsors
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Lexicon Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Ikenna (Ike) Ogbaa, M.D.
Role: STUDY_DIRECTOR
Lexicon Pharmaceuticals, Inc.
Locations
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Lexicon Investigational Site
Austin, Texas, United States
Countries
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Other Identifiers
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LX4211.109
Identifier Type: OTHER
Identifier Source: secondary_id
LX4211.1-109-NRM
Identifier Type: -
Identifier Source: org_study_id