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PSI-7977 Has No Effect on QTcF Intervals at Therapeutic or Supratherapeutic Doses
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Reported by Jules Levin
AASLD 2011 SF Nov 5-8
M.T. Cornpropst1, J.M. Denning1, D. Clemons1, L. Fang2, M. Sale3, M.M. Berrey1, W.T. Symonds1
1Pharmasset, Inc., Princeton, NJ, 2Pharstat, Inc., Research Triangle Park, NC, 3Next Level Solutions, Raleigh, NC
CONCLUSION
A single 1200 mg dose of PSI-7977 meets the criteria for providing supratherapeutic exposures
Single doses up to 1200 mg of PSI-7977 are well-tolerated by healthy subjects in this study
There continues to be no maximal tolerated dose of PSI-7977 in humans
PSI-7977, at doses up to 1200 mg, does not have a clinically meaningful effect on QTcF intervals
These results indicate that PSI-7977 can be administered without the need for additional ECG monitoring
Lack of QTc effect demonstrated in this study allows use of concomitant medications with a known QT effect, such as SSRIs
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