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Single Therapeutic and Supratherapeutic Doses of Laropiprant, a Selective Prostaglandin D 2 Receptor 1 Antagonist, Do Not Prolong the QTcF Interval in Healthy Volunteers
Author(s) -
Luo WenLin,
Crumley Tami,
Ebel David,
Atiee George J.,
Royalty Jane,
JohnsonLevonas Amy O.,
Wagner John,
Lai Eseng
Publication year - 2010
Publication title -
the journal of clinical pharmacology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.92
H-Index - 116
eISSN - 1552-4604
pISSN - 0091-2700
DOI - 10.1177/0091270009360042
Subject(s) - medicine , moxifloxacin , placebo , qt interval , assay sensitivity , confidence interval , anesthesia , pharmacology , alternative medicine , pathology , microbiology and biotechnology , biology , antibiotics
Laropiprant (LRPT), a prostaglandin D 2 receptor‐1 antagonist shown to reduce niacin‐induced flushing symptoms, has been combined with niacin for treatment of dyslipidemia. This study evaluated the effects of LRPT (50 mg and 600 mg, respectively) on the QT interval with Fridericia's correction (QTcF). QTcF measurements were made over a 24‐hour period following administration of single‐dose moxifloxacin 400 mg, LRPT 50 mg, LRPT 600 mg, or placebo. The primary hypothesis was supported if the 90% confidence intervals (CIs) for the least squares (LS) mean differences between placebo and LRPT in change from baseline in QTcF interval were <10 milliseconds at every time point. The upper limits of the 90% CIs for LS mean differences from placebo in changes from baseline in QTcF intervals for LRPT 50 mg and 600 mg were <5 milliseconds at every time point. The lower limits of the 90% CIs for placebo‐adjusted LS mean changes from baseline in QTcF intervals for moxifloxacin exceeded 0 milliseconds at every time point, demonstrating the sensitivity of this assay to detect increases in the QTcF interval. In conclusion, single doses of LRPT 50 mg and 600 mg do not prolong the QTcF interval relative to placebo and are generally well tolerated.