NDLI: A single supratherapeutic dose of rolofylline does not prolong the QTcF interval in healthy volunteers.

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A single supratherapeutic dose of rolofylline does not prolong the QTcF interval in healthy volunteers.

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A single supratherapeutic dose of rolofylline does not prolong the QTcF interval in healthy volunteers.

Content Provider	World Health Organization (WHO)-Global Index Medicus
Author	Radziszewski, Waldemar Lai, Eseng Lazarus Shipitofsky, Nicole Stroh, Mark Dishy, Victor Han, Lingling Lewis, William Johnson-Levonas, Amy O. Lutz, Ryan Wagner, John
Description	Country affiliation: United States Author Affiliation: Radziszewski W ( Merck Research Laboratories, Rahway, NJ, USA. waldemar_radziszewski@merck.com)
Abstract	Rolofylline is a potent, selective adenosine A1 receptor antagonist that was under development for the treatment of patients with acute decompensated heart failure and renal function impairment. The 30-mg dose of rolofylline administered by intravenous infusion over 4 hours for 3 days represented the anticipated recommended clinical regimen of rolofylline. This was a randomized, double-blind, double-dummy, placebo-controlled, three-period crossover study performed with a single 2-hour intravenous infusion of 60 mg rolofylline, placebo, or oral moxifloxacin in healthy subjects. Plasma samples were collected for determination of rolofylline, M1-trans, and M1-cis pharmacokinetic parameters. The upper limit of the two-sided 90% confidence interval for the placebo-adjusted least squares mean change from baseline in QTcF interval for rolofylline was less than 5 msec at every time point. Moxifloxacin demonstrated an increase in QTcF of greater than 10 msec at 2, 2.5, and 3 hours postdose, thus establishing the sensitivity of the assay to detect modest increases in QTcF interval. Mean Cmax values of 1947.4, 739.2, and 54.8 nM were attained for rolofylline and its metabolites M1-trans and M1-cis, respectively, which were 2.2- to 3.1-fold higher than historic Cmax values seen at the anticipated clinical dose and regimen. Adenosine A1 receptor antagonism from a single supratherapeutic intravenous dose of 60 mg rolofylline over 2 hours was generally well tolerated and did not prolong the QTcF interval relative to placebo.
File Format	HTM / HTML
ISSN	10752765
Issue Number	1
Volume Number	17
e-ISSN	15363686
Journal	American Journal of Therapeutics
Language	English
Publisher	Lippincott Williams & Wilkins
Publisher Date	2010-01-01
Publisher Place	United States
Access Restriction	One Nation One Subscription (ONOS)
Subject Keyword	Discipline Pharmacology Adenosine A1 Receptor Antagonists Diuretics Adverse Effects Xanthines Administration, Oral Adult Aza Compounds Cross-over Studies Administration & Dosage Pharmacokinetics Dose-response Relationship, Drug Double-blind Method Electrocardiography Female Fluoroquinolones Humans Infusions, Intravenous Long Qt Syndrome Chemically Induced Male Middle Aged Quinolines Young Adult Comparative Study Journal Article Randomized Controlled Trial Research Support, Non-u.s. Gov't
Content Type	Text
Resource Type	Article
Subject	Pharmacology Pharmacology (medical)

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