A Phase 1 Thorough QT/QTc Study of Therapeutic and Supratherapeutic Doses of Belumosudil in Healthy Subjects
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DOI: 10.1002/cpdd.1142
Abstract: Belumosudil is a selective Rho‐associated, coiled‐coil‐containing protein kinase‐2 inhibitor. In this crossover design thorough QT/QTc study, single therapeutic (200 mg) and supratherapeutic (1000 mg) oral doses of belumosudil, moxifloxacin (positive control), and placebo were administered… read more here.
Keywords: effect; therapeutic supratherapeutic; thorough qtc; doses belumosudil ... See more keywords
Thorough QTc Evaluation and the Safety of Supratherapeutic Doses of Odanacatib in Healthy Subjects
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DOI: 10.1002/cpdd.698
Abstract: Assessing risk for QTc interval prolongation in a thorough QTc study is a standard recommendation when evaluating new chemical entities. As part of the clinical development program for odanacatib, an oral selective inhibitor of cathepsin… read more here.
Keywords: safety; qtc evaluation; study; thorough qtc ... See more keywords
Thorough QT/QTc Evaluation of the Cardiac Safety of Secnidazole at Therapeutic and Supratherapeutic Doses in Healthy Individuals
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DOI: 10.1002/jcph.1014
Abstract: SYM‐1219, a novel oral granule formulation of secnidazole, is under development as single‐dose treatment for bacterial vaginosis. This 4‐way, randomized, crossover study evaluated the effects of SYM‐1219 on electrocardiographic (ECG) parameters in 52 healthy subjects.… read more here.
Keywords: sym 1219; qtc evaluation; safety; evaluation cardiac ... See more keywords
A powerful test for the maximum treatment effect in thorough QT/QTc studies.
Sign Up to like & getrecommendations! Published in 2021 at "Statistics in medicine"
DOI: 10.1002/sim.8881
Abstract: Parallel-group thorough QT/QTc studies focus on the change of QT/QTc values at several time-matched points from a pretreatment day (baseline) to a posttreatment day for different groups of treatment. The International Council for Harmonisation E14… read more here.
Keywords: qtc; qtc prolongation; qtc studies; treatment ... See more keywords
Teneligliptin and “Thorough QTc study”: thorough enough?
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DOI: 10.2147/dmso.s220562
Abstract: Department of Endocrinology, Nightingale Hospital, Kolkata, India Dear editor I read with interest the “Thorough QTc study” with teneligliptin by Erande et al. It came as a surprise to me that the basic structure required… read more here.
Keywords: teneligliptin thorough; qtc study; thorough qtc; study ... See more keywords