Randomized, Double-blind, Placebo-controlled, Positive-controlled, 4-period, 4-way Crossover Study to Define the Electrocardiogram Effects of a Single Dose of LX4211 800 mg and 2000 mg Compared With Placebo and Open-label Moxifloxacin in Healthy Subjects: A Thorough QT Study
Overview
- Phase
- Phase 1
- Intervention
- LX4211 Placebo
- Conditions
- Healthy
- Sponsor
- Lexicon Pharmaceuticals
- Enrollment
- 63
- Locations
- 1
- Primary Endpoint
- Change from baseline in QTc intervals
- Status
- Completed
- Last Updated
- 12 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Arms & Interventions
Treatment A
LX4211 800 mg
Intervention: LX4211 Placebo
Treatment D
Placebo
Intervention: LX4211 2000 mg
Treatment D
Placebo
Intervention: moxifloxacin 400 mg
Treatment A
LX4211 800 mg
Intervention: LX4211 800 mg
Treatment A
LX4211 800 mg
Intervention: LX4211 2000 mg
Treatment A
LX4211 800 mg
Intervention: moxifloxacin 400 mg
Treatment B
LX4211 2000 mg
Intervention: LX4211 800 mg
Treatment B
LX4211 2000 mg
Intervention: LX4211 2000 mg
Treatment B
LX4211 2000 mg
Intervention: moxifloxacin 400 mg
Treatment B
LX4211 2000 mg
Intervention: LX4211 Placebo
Treatment C
moxifloxacin 400 mg
Intervention: LX4211 800 mg
Treatment C
moxifloxacin 400 mg
Intervention: LX4211 2000 mg
Treatment C
moxifloxacin 400 mg
Intervention: moxifloxacin 400 mg
Treatment C
moxifloxacin 400 mg
Intervention: LX4211 Placebo
Treatment D
Placebo
Intervention: LX4211 800 mg
Treatment D
Placebo
Intervention: LX4211 Placebo
Outcomes
Primary Outcomes
Change from baseline in QTc intervals
Time Frame: Day -1, Day 1 of each period (2, 3, 4)
Secondary Outcomes
- 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)
- Number of subjects experiencing an adverse event(up to 87 days)