Interesting that GSK is just beginning a pharmacokinetics study before the main trial is over. Wonder if they have an inkling things are going well. Probably can't read much into it:
Study to Determine the Effect of Repeated Administration of Diltiazem on the Pharmacokinetics of Darapladib (Sb-480848).
Darapladib (SB-480848) is a novel, selective, orally active inhibitor of lipoprotein associated phospholipase A2 (Lp-PLA2) currently under clinical development by GlaxoSmithKline as a potential anti-atherosclerosis agent for reduction of major adverse cardiovascular (CV) events in patient populations with chronic coronary heart disease and after an acute coronary syndrome.
This study will determine the effect of repeated administration of diltiazem on the pharmacokinetics of a repeated administration of darapladib. A drug interaction study with a moderate CYP3A4 inhibitor is warranted to provide guidance to prescribing physicians.
This it it! First sign trial is a winner,IMO. With data imminent, why not wait???? I think they did wait 4 years to start this now because they are pretty confident what the outcome is. With the 3 and 4 year studies lasting so long, and being event driven, math guys inside Glaxo know the trends. fun stuff should be going on here in the next 5 months. 1 dollar will look like to be the buy of the century. Sorry for hyping, but i am so confident Glaxo knows what they have here. The first obvious sign was the purchase of HGSI for 3.2 billion dollars. That company and Benlysta were on the verge of collapse.... The 25% stake in Darapladib was too valuable to let some competitor get their hands on it.
The Smelkster has Spoken.
GSK has also studied the PK of darapladib vs rosuvastatin (Crestor) in a study that began 12/12 and ended 3/13. No results published yet. Also have looked at effect of darapladib on pts with severe renal impairment that started 9/12 nd ended 3/13. No results published. This last one looks like an FDA mandated excercize. Cardizem study has yet to begin.