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First published on June 2, 2008, doi:10.1177/0091270008319793

The Journal of Clinical Pharmacology 2008;48:926.

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©© 2008 American College of Clinical Pharmacology, Inc.
The Journal of Clinical Pharmacology , 10.1177/0091270008319793

Article

Single-Dose Pharmacokinetics, Pharmacodynamics, Tolerability, and Safety of the Soluble Guanylate Cyclase Stimulator BAY 63-2521: An Ascending-Dose Study in Healthy Male Volunteers

Reiner Frey 1*, Wolfgang Mück 1, Sigrun Unger 1, Ulrike Artmeier-Brandt 1, Gerrit Weimann 1, and Georg Wensing 1

1 Bayer HealthCare AG

* To whom correspondence should be addressed. E-mail: reiner.frey{at}bayerhealthcare.com.


  Abstract
The aim of the study was to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of BAY 63-2521, a new drug in development for pulmonary hypertension. Fifty-eight healthy male volunteers received a single oral dose of BAY 63-2521 (0.25-5 mg) or placebo. No serious adverse events were reported; there were no life-threatening events. Heart rate over 1 minute, an indicator of the effect of a vasodilating agent on the cardiovascular system in healthy subjects, was increased dose dependently versus placebo at BAY 63-2521 doses of 1 to 5 mg (P <.01). Mean arterial and diastolic pressures were decreased versus placebo at doses of 1 mg (P <.05) and 5 mg (P <.01). Systolic pressure was not significantly affected. BAY 63-2521 was readily absorbed and exhibited dose-proportional pharmacokinetics. The pharmacodynamic and pharmacokinetic properties of BAY 63-2521 suggest that it can offer a unique mode of action in the treatment of pulmonary hypertension.
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H. A. Ghofrani and F. Grimminger
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