Near-thorough QT study as part of a first-in-man study.

@article{Malik2008NearthoroughQS,
  title={Near-thorough QT study as part of a first-in-man study.},
  author={Marek Malik and Katerina Hnatkova and John S Ford and David Madge},
  journal={Journal of clinical pharmacology},
  year={2008},
  volume={48 10},
  pages={1146-57}
}
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… CONTINUE READING

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