Effect of AKB-6548 on Cardiac Repolarization Intervals in Healthy Volunteers (NCT02062203) | Clinical Trial Compass
CompletedPhase 1
Effect of AKB-6548 on Cardiac Repolarization Intervals in Healthy Volunteers
United States50 participantsStarted 2014-01
Plain-language summary
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.
Who can participate
Age range18 Years – 55 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
Placebo-corrected change-from-baseline QTcF (ΔΔQTcF) following AKB-6548 administration.
Timeframe: multiple timepoint evaluations from pre-dose to 24 hours post-dose