J Clin Pharmacol
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First published on April 25, 2008, doi:10.1177/0091270008318007

The Journal of Clinical Pharmacology 2008;48:726.

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©© 2008 American College of Clinical Pharmacology, Inc.
The Journal of Clinical Pharmacology , 10.1177/0091270008318007

Article

Raltegravir Thorough QT/QTc Study: A Single Supratherapeutic Dose of Raltegravir Does Not Prolong the QTcF Interval

M. Iwamoto 1*, J. T. Kost 1, G. C. Mistry 1, L. A. Wenning 1, S. A. Breidinger 1, T. C. Marbury 2, J. A. Stone 1, K. M. Gottesdiener 1, D. M. Bloomfield 1, and J. A. Wagner 1

1 Merck & Co, Inc
2 Orlando Clinical Research Center

* To whom correspondence should be addressed. E-mail: marian_iwamoto{at}merck.com.


  Abstract
Raltegravir is a novel HIV-1 integrase inhibitor with potent in vitro activity (IC95 = 31 nM in 50% human serum). A double-blind, randomized, placebo-controlled, double-dummy, 3-period, single-dose crossover study was conducted; subjects received single oral doses of 1600 mg raltegravir, 400 mg moxifloxacin, and placebo. The upper limit of the 2-sided 90% confidence interval for the QTcF interval placebo-adjusted mean change from baseline of raltegravir was less than 10 ms at every time point. For the raltegravir and placebo groups, there were no QTcF values >450 ms or change from baseline values >30 ms. A mean Cmax of ~20 µM raltegravir was attained, ~4-fold higher than the Cmax at the clinical dose. Moxifloxacin demonstrated an increase in QTcF at the 2-, 3-, and 4-hour time points. Administration of a single supratherapeutic dose of raltegravir does not prolong the QTcF interval. A single supratherapeutic dose design may be appropriate for crossover thorough QTc studies.
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