Effect of AKB-6548 on Cardiac Repolarization Intervals in Healthy Volunteers

A Phase 1, Single-Center, Partially Double-Blinded, Active and Placebo Controlled, Randomized 4-Way Crossover Study to Evaluate the Effect of AKB-6548 on Cardiac Repolarization Intervals in Healthy Volunteers

The main purpose of this study is to evaluate the effect of single oral therapeutic and supratherapeutic doses of AKB-6548 on the QT interval.

Key Inclusion Criteria:

• Healthy, non-smoking males or females, 18 and 55 years of age, inclusive
• BMI 18.0 and 32.0 kg/m2, inclusive
• non clinically significant 12-lead ECG
• heart rate of 45 to 90 beats per minute, inclusive
• mean systolic blood pressure <141 mmHg and mean diastolic blood pressure < 90 mmHg

Key Exclusion Criteria:

• history or presence of significant cardiovascular, pulmonary, hepatic, renal, hematologic, GI, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease
• history of unexplained syncope, cardiac arrest, unexplained cardiac arrhythmias, or torsades de pointes, structural heart disease, or a family history of Long QT syndrome
• significant abnormalities in liver function tests
• history of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs
• history of Gilbert's Syndrome
• positive hepatitis panel
• seizure disorder or receiving anti-epilepsy medication for seizure disorder
• any acute or chronic condition that, in the opinion of the Investigator, may pose a safety risk to a subject in this study or which would limit the subject's ability to complete and/or participate in this clinical study