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Single therapeutic and supratherapeutic doses of anacetrapib, a cholesteryl ester transfer protein inhibitor, do not prolong the QTcF interval in healthy volunteers
Author(s) -
Lauring Brett,
Liu Yang,
Li Xiujiang Susie,
Larson Patrick,
Moreau Allison,
Farmer H. Frank,
JohnsonLevonas Amy O.,
Wagner John A.,
Lai Eseng
Publication year - 2014
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 - 10.1002/jcph.278
Subject(s) - medicine , pharmacology , cholesterylester transfer protein , qt interval , pharmacokinetics , anesthesia , cholesterol , lipoprotein
Abstract Anacetrapib is a cholesteryl ester transfer protein inhibitor in Phase III development. This double‐blind, double‐dummy, randomized, placebo‐ and active‐comparator‐controlled, 4‐period, balanced crossover study evaluated the effects of anacetrapib (100 mg and 800 mg) on QTcF interval in healthy subjects. QTcF measurements were made up to 24 h following administration of single doses of anacetrapib 100 or 800 mg, moxifloxacin 400 mg, or placebo in the fed state. The primary hypothesis was supported if the 90% CI for the least squares (LS) mean differences between anacetrapib 800 mg and placebo in QTcF interval change from baseline were entirely <10 msec at every post‐dose time point (1, 2, 2.5, 3, 4, 5, 6, 8, 12, and 24 h). The upper bounds of the 90% CIs for LS mean differences from placebo in changes from baseline in QTcF intervals for anacetrapib 100 and 800 mg were <5 msec at every time point. In conclusion, single doses of anacetrapib 100 and 800 mg do not prolong the QTcF interval to a clinically meaningful degree relative to placebo and are generally well tolerated in healthy subjects.