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news.Galapagos has completed the first-in-human trial for GLPG0492, its candidate drug for cachexia (loss of weight and muscle mass) and potentially other indications, such as Duchenne muscular dystrophy, which showed good safety in healthy volunteers and a pharmacokinetic (PK) profile which supports once-daily oral dosing.
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The double- blind, single ascending dose study was conducted in 16 young healthy human volunteers, with 12 receiving ascending doses of GLPG0492 (ranging 0.5 to 120mg) and four receiving placebo.
In this first-in-human trial, healthy volunteers were given increasing doses of candidate drug GLPG0492 by oral administration.
Galapagos said that the safety data were favorable with no severe adverse events or changes in vital signs and laboratory parameters reported.
Galapagos plans to conduct a second Phase I trial in healthy volunteers in the course of 2011 to assess the safety and tolerability of GLPG0492 over at least 14 consecutive days. Based on this trial, a Proof of Concept study is scheduled for late 2011.
Galapagos Development SVP Piet Wigerinck said that they are encouraged by the results of this first clinical trial for GLPG0492.
"Comparable safety and PK profiles were seen for younger and elderly volunteers, the latter being particularly relevant for a therapeutic aimed at improving muscle function," Wigerinck said.