Double-Blind Randomized Crossover Trial to Access Electrocardiogram Effects of HPN-100
Status:
Completed
Trial end date:
2010-09-01
Target enrollment:
Participant gender:
Summary
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).
Phase:
Phase 1
Details
Lead Sponsor:
Horizon Pharma Ireland, Ltd., Dublin Ireland
Treatments:
Glycerol Moxifloxacin Norgestimate, ethinyl estradiol drug combination