J Clin Pharmacol
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First published on August 29, 2008, doi:10.1177/0091270008323261

The Journal of Clinical Pharmacology 2008;48:1146.

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©© 2008 American College of Clinical Pharmacology, Inc.
The Journal of Clinical Pharmacology, 10.1177/0091270008323261

Article

Near-Thorough QT Study as Part of a First-In-Man Study

Marek Malik 1*, Katerina Hnatkova 1, John Ford 2, and David Madge 2

1 St. Paul's Cardiac Electrophysiology
2 Xention Ltd

* To whom correspondence should be addressed. E-mail: marek.malik{at}btinternet.com.


  Abstract
Detailed electrocardiographic (ECG) support was provided to a first-in-man, single-ascending-dose study that included 6 cohorts of 8 male volunteers each. In each cohort, 6 and 2 subjects received active compound and placebo, respectively. Long-term 12-lead ECGs were obtained on baseline day –1, dosing day 1, and day 2. Automatic QT-interval measurements were made at 63 time points (28 at baseline and 35 on treatment). Based on QT/RR distribution, 20% of measurements were visually verified. Baseline-corrected time-matched {Delta}QTc values were obtained at 35 postdose time points. Placebo subjects of all cohorts were pooled. When 2 cohorts of the lowest, middle, and highest doses were pooled (12 subjects per active treatment group), the spreads of placebo-corrected {Delta}{Delta}QTc values were within the regulatory requirements (single-sided 95% confidence interval <10 milliseconds) at all time points. Thus, this ECG support of the first-in-man study provided data of regulatory acceptable accuracy at a small fraction of the cost of a full thorough QT study.
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Model-Based Evaluation of QTc Interval Risk: An Increasing Emphasis on Early Decision Making
J. Clin. Pharmacol., September 1, 2009; 49(9): 1010 - 1011.
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