A Study of Glyceryl Tri-(4-phenylbutyrate) (GT4P)

Phase 1 Completed 24 enrolled Amgen Ucyclyd Pharma, Inc. · collab

RandomizedCrossoverOpen-labelTreatment

Summary

To determine the safety and tolerability of single oral doses of HPN-100 as a formulation (GT4P-F) and GT4P as the active pharmaceutical ingredient (GT4P-API) administered to healthy male subjects.

Timeline

Start: 2005-03
Primary completion: —
Completion: 2005-07

Publications

McGuire BM, Zupanets IA, Lowe ME, Xiao X, Syplyviy VA, Monteleone J, Gargosky S, Dickinson K, Martinez A, Mokhtarani M, Scharschmidt BF. Pharmacology and safety of glycerol phenylbutyrate in healthy adults and adults with cirrhosis. Hepatology. 2010 Jun;51(6):2077-85. doi: 10.1002/hep.23589.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Ammonul	Unknown	2750 mg/m2	Intravenous
Subject	Glycerol phenylbutyrate	Other / unclassified	3000 mg/m2	Oral
Comparator	Sodium Phenylbutyrate	Small molecule	3000 mg/m2	Oral

Indications

No indication recorded.