Drug Toxicity Clinical Trial
Official title:
Double-Blind Randomized Placebo-Control Trial to Evaluate Electrocardiogram Effects of HPN-100 as Defined by Clinical and Supratherapeutic Dose in Healthy Men and Women
Arm 1:
Primary Objective:
• To determine the safety and tolerability of multiple ascending, supratherapeutic doses of
HPN-100.
Arm 2:
Primary Objective:
• To assess the effects of steady-state levels of HPN-100 metabolites (4 phenylbutyric acid
[PBA], phenylacetic acid [PAA], and phenylacetylglutamine [PAGN]) on 12-lead
electrocardiogram (ECG) parameters in healthy male and female subjects with the primary
endpoint being the time-matched change from baseline in the QT interval corrected for heart
rate (HR) based on an individual correction method (QTcI).
Assess the effects of steady-state levels of HPN-100 metabolites (4-phenylbutryic acid (PBA), phenylacetic acid (PAA), and phenylacetylglutamine (PAGN) on 12-lead electrocardiogram (ECG) parameters in health male and female subjects with the primary endpoint being the time-matched change from baseline in the QT interval corrected for heart rate(HR) based on an individual correction method (QTcl). ;
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