46
Participants
Start Date
October 31, 2009
Primary Completion Date
September 30, 2010
Study Completion Date
September 30, 2010
HPN-100
HPN-100 is a triglyceride that has a similar mechanism of action as NaPBA. It is a liquid with minimal taste and odor. Three teaspoons of HPN-100 (\~17.4mL) delivers equivalent amount of PBA in 40 tablets of NaPBA.
Buphenyl (NaPBA)
Buphenyl (NaPBA) will be the comparator drug to HPN-100 in this study.
Mount Sinai School of Medicine, New York
Westchester Medical Center, Valhalla
Children's Hospital of Pittsburgh of UPMC, Pittsburgh
Children's National Medical Center, Washington D.C.
SNBL-Clinical Pharmacology Center, Baltimore
University of Florida, Gainesville
Nationwide Children's Hospital, Columbus
University Hospitals Case Medical Center, Cleveland
University of Iowa, Iowa City
Medical College of Wisconsin, Milwaukee
University of Minnesota Medical Center, Minneapolis
Baylor College of Medicine, Houston
Denver Children's Hospital, Aurora
University of Utah, Salt Lake City
UCLA, Los Angeles
Long Beach Memorial, Long Beach
Stanford University, Stanford
Oregon Health & Science University, Portland
Yale School of Medicine, New Haven
Maine Medical Center, Portland
Tufts-New England Medical Center, Boston
The Hospital for Sick Children, Toronto
Lead Sponsor
Amgen
INDUSTRY