| QT effect of semagacestat at therapeutic and supratherapeutic doses. | |
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MedLine Citation:
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PMID: 22456300 Owner: NLM Status: In-Data-Review |
Abstract/OtherAbstract:
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Objective: This thorough QT/ QT interval corrected for heart rate (QTc) study was designed to assess the potential of semagacestat, a functional gamma-secretase inhibitor, to delay cardiac repolarization. Methods: In this Phase I, single-dose, randomized, 4-period crossover study, semagacestat was compared with placebo in 54 healthy male and female subjects between the ages of 19 and 63 years, inclusive. Each study period included single oral-dose administrations of semagacestat 140 mg, semagacestat 280 mg, moxifloxacin 400 mg, or placebo. Study subjects and the investigator were blinded to the identity of semagacestat and placebo; however, moxifloxacin was administered as open-label. Moxifloxacin was compared with placebo for assay sensitivity analysis. Pharmacokinetic parameters were also assessed. Results: For each QTc, the upper bound of the 2-sided 90% confidence interval (CI) for the least squares mean difference between semagacestat (at both the 140- and 280-mg dose levels) and placebo was < 10 msec at all time points, and thus, within the limits set for clinical relevance in regulatory guidelines. Conclusions: The results of this study indicate that single doses of 140 and 280 mg semagacestat did not prolong QTc to a clinically significant degree. |
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Authors:
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Wei Zhang; Mosun Ayan-Oshodi; Brian A Willis; William Annes; Stephen D Hall; Joseph Chiesa; Mary Seger |
Publication Detail:
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Type: Journal Article |
Journal Detail:
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Title: International journal of clinical pharmacology and therapeutics Volume: 50 ISSN: 0946-1965 ISO Abbreviation: Int J Clin Pharmacol Ther Publication Date: 2012 Apr |
Date Detail:
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Created Date: 2012-03-29 Completed Date: - Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 9423309 Medline TA: Int J Clin Pharmacol Ther Country: Germany |
Other Details:
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Languages: eng Pagination: 290-9 Citation Subset: IM |
Affiliation:
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Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, USA, and Covance Clinical Research Unit Ltd, Springfield House, Leeds, UK. |
Export Citation:
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From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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