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 |
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.
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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