A Study to Investigate the Effects of CBP-307 on the Heart Rate-corrected QT Interval (QTc) in Healthy Subjects

Inclusion Criteria

• Males or females, of any race, between 18 and 60 years of age, inclusive.
• Body mass index between 18.0 and 30.0 kg/mE2, inclusive.
• In good health, determined by no clinically significant findings from medical history, physical examination, 12-lead ECG, vital signs measurements, and clinical laboratory evaluations (congenital nonhemolytic hyperbilirubinemia [eg, suspicion of Gilbert's syndrome based on total and direct bilirubin] is not acceptable) at screening and confirmed at check-in as assessed by the investigator (or designee).
• Females will not be pregnant or lactating, and females of childbearing potential and males will agree to use contraception. Negative pregnancy test for females of childbearing potential at screening (blood test) and check-in (urine test).
• Supine diastolic blood pressure between 60 and 90 mmHg and systolic blood pressure between 90 and 140 mmHg (inclusive) at screening on a single measurement (confirmed by a single repeat, if necessary) following at least 5 minutes of rest.
• No clinically significant history or presence of ECG findings as judged by the investigator at screening and check-in, including each criterion as listed below:
• Normal sinus rhythm (HR between 55 bpm and 100 bpm inclusive);
• QTcF interval ≤450 msec for males and females;
• QRS interval ≤110 msec; and confirmed by manual over-read if >110 msec;
• PR interval ≤200 msec.
• Has serum potassium, calcium, and magnesium levels within the normal reference range at screening, as judged by the investigator.
• Able to swallow multiple tablets (based on subject's verbal confirmation).
• Able to comprehend and willing to sign an ICF and to abide by the study restrictions.

Exclusion Criteria

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Subjects will be excluded from the study if they satisfy any of the following criteria at the screening visit unless otherwise stated:

• Subject is mentally or legally incapacitated or has had significant history of recent mental health issues requiring medication and/or hospitalization at the time of the screening visit or expected during the conduct of the study.
• Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the investigator (or designee). Note: Childhood asthma that is considered recovered or seasonal allergies that are not currently active or requiring treatment are allowed.
• History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the investigator (or designee).
• History or presence of hypersensitivity or idiosyncratic reaction to the study drugs, related compounds, or inactive ingredients.
• History of significant multiple and/or severe allergies (eg, latex allergy, band-aids, adhesive dressing, or medical tape), or has had an anaphylactic reaction or significant intolerability to prescription or nonprescription drugs.
• History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs within 6 months prior to the first dose of study drug (uncomplicated appendectomy and hernia repair will be allowed).
• History or presence of:
• Hypokalemia, in the opinion of the investigator (or designee);
• Risk factors for Torsades de Pointes (eg, heart failure, cardiomyopathy, or family history of Long QT Syndrome);
• 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.
• Clinically significant abnormalities (as judged by the investigator in laboratory tests results [out-of-ra