A Phase 1, Randomized, Placebo-and Positive-Controlled Crossover Study to Determine the Effect of Single-Dose GC4419 on QTc Interval in Healthy Volunteers

Inclusion criteria

• Healthy, adult, male or female, 18-55 years of age
• Continuous non-smoker who has not used nicotine-containing products for at least 3 months prior to the first dose.
• Must weigh at least 60 kg for males or 52 kg for females and have a body mass index (BMI) ≥ 18.0 and ≤ 30.0 kg/m2
• Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs, or ECGs
• For a female of childbearing potential: either be sexually inactive as a voluntary lifestyle choice for at least 1 year prior to first dosing until 21 days following last dosing or be using an acceptable birth control method
• For a female of non-childbearing potential: must have undergone an acceptable sterilization procedure or be postmenopausal for at least 1 year prior to the first dose
• Willing and able to comply with the protocol.
• Seated blood pressure between 90/40 mmHg and 140/90 mmHg
• Has serum potassium, calcium, and magnesium levels within the normal range at screening.

Exclusion criteria

• History or presence of clinically significant medical or psychiatric condition, disease or illness
• History or presence of alcoholism or drug abuse within the past 2 years
• History or presence of hypersensitivity to the study drugs
• History of significant multiple and/or severe allergies
• Female subjects who are pregnant or lactating.
• Positive results at screening for human immunodeficiency virus (HIV), syphilis, hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV).
• Unable to refrain from or anticipates the use of any drug, including prescription and non-prescription medications 14 days prior to the first dose of study drug and throughout the study.
• Any drugs known to be significant inhibitors or inducers of CYP enzymes and/or P-gp, including St. John's Wort, for 28 days prior to the first dose of study drug and throughout the study.
• Has been on a diet incompatible with the on-study diet, within the 28 days prior to the first dose of study drug, and throughout the study.
• Donation of blood or significant blood loss within 56 days
• Plasma donation within 7 days prior to the first dose of study drug.
• Has had surgery or any medical condition which may affect the absorption, distribution, metabolism, or elimination of the study drug within 6 months.
• Participation in another clinical trial within 28 days
• Participation in a previous clinical trial where subject received GC4419.
• History or presence of: hypokalemia, risk factors for Torsades de Pointes , sick sinus syndrome, second, or third degree atrioventricular block, myocardial infarction, pulmonary congestion, cardiac arrhythmia, prolonged QT interval, or conduction abnormalities; repeated or frequent syncope or vasovagal episodes; hypertension, angina, bradycardia, or severe peripheral arterial circulatory disorders.