Evaluation of the Effect of ATX-101 on QT/QTc Intervals

Exclusion Criteria

• •Any prescription medication taken within 14 days (or 5 elimination half-lives, whichever is longer) of Study Day -2, or have taken any over-the-counter medications, including topical medications, herbal or dietary supplements/remedies within 7 days of Study Day 2, or planned concomitant medication while in the study (except for acetaminophen up to 2 g/day and hormonal birth control).
• •A history of additional risk factors for Torsade de Pointes (e.g. hypokalemia, history of drowning survival, family history of Long QT Syndrome, family history of Short QT Syndrome, or family history of unexplainable early sudden death).
• •Participation in a study of an investigational drug or device within 30 days prior to the baseline ECG.
• •Any condition that, in the judgment of the investigator, would place a subject at undue risk, or potentially compromise the results or interpretation of the study.
• •Uncontrolled cardiac arrhythmias, for example, atrial fibrillation with a ventricular response at rest \> 100 beats per minute.
• •Known abnormality of any cardiac valve (either stenosis or regurgitation) that is greater than moderate in severity.
• •Subjects not in sinus rhythm at screening.
• •Hypersensitivity to Moxifloxacin
• •History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease.
• •Use of tobacco or nicotine-containing products within 3 months prior to dose.
• •History of any intervention to treat submental fat (e.g. liposuction, surgery, or lipolytic agents).
• •History of trauma associated with the chin or neck areas, which in the judgment of the investigator may affect evaluation of safety of treatment.
• •Loose skin in the neck or chin area for which reduction in submental fat may, in the judgment of the investigator, result in a cosmetically unacceptable outcome.
• •Prominent platysmal bands at rest that interfere with the evaluation of submental fat.
• •Evidence of any cause of enlargement in the submental area other than localized subcutaneous fat.
• •Any blood donation or significant blood loss within 56 days before the dose of study material or plasma donation within 7 days of Day -1.
• •A result on coagulation tests (PT, PTT) obtained within 28 days before the dose of study material that indicates the presence of any clinically significant bleeding disorder.
• •Any medical condition that would interfere with the assessment of safety in this trial or would compromise the ability of the subject to undergo study procedures or to give informed consent.
• •Treatment with oral anticoagulants (e.g. warfarin) within 30 days before dosing with study material.
• •Treatment with radio frequency, laser procedure, chemical peels, or dermal fillers in the neck or chin within 12 months before dosing with the study material, or botulinum toxin injections in the neck or chin area within 6 months before dosing with the study material.
• •History of sensitivity to any components of the study material.
• •History of drug or alcohol abuse, in the judgment of the investigator, within two years before dosing with the study material.
• •Presence of positive urine drug or alcohol screening test result obtained from a sample obtained during the screening period and/or after admission to the research facility for the confinement period, but before dosing with the study material.
• •Previous enrollment in a trial of ATX-101.
• •Treatment with an investigational device or agent within 30 days prior to the baseline ECG.