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



Status:Completed
Conditions:Healthy Studies
Therapuetic Areas:Other
Healthy:No
Age Range:18 - 55
Updated:11/16/2018
Start Date:January 2014
End Date:April 2014

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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
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