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Autor:
Scott A. Van Wart, Julie D. Seroogy, Jonathan Gall, Jacqueline A. Gibbons, Taylor Choi, Valerie Riddle
Publikováno v:
Clinical Pharmacology in Drug Development. 8:1032-1041
Plazomicin is an aminoglycoside with in vitro activity against multidrug-resistant Enterobacteriaceae. A phase 1, randomized, double-blind, crossover study assessed the potential effects of plazomicin on cardiac repolarization (NCT01514929). Fifty-si
Publikováno v:
Clinical Pharmacology in Drug Development. 7:641-651
This study evaluated the effect of supratherapeutic exposure of the anti-HCV drug ledipasvir on the QTc interval in healthy subjects. Sixty healthy volunteers were randomized to receive twice-daily blinded ledipasvir (120 mg) or placebo, administered
Autor:
Yu Chung Tsang, Anne Stilman, Anna Rozova, Caroline Fradette, Mark J. Allison, Fernando Tricta
Publikováno v:
Clinical Pharmacology in Drug Development. 7:22-32
This study evaluated whether deferiprone, an oral iron chelator, acts to prolong the QT interval. Fifty healthy volunteers received single doses of each of the following: therapeutic dose of deferiprone (33 mg/kg), supratherapeutic dose (50 mg/kg), p
Autor:
Michelle Marie Lockhart, Holger Weis, Donna Tunnicliff, Sarah Harland, Borje Darpo, Jane Devane, R. S. Crockett, Gavin Cape, John Howes, C. Tak Hung, Meijian Zhou, Lawrence Friedhoff, Noelyn Hung, Fred Lam, Paul Glue
Publikováno v:
Clinical Pharmacology in Drug Development. 5:460-468
Ibogaine is a psychoactive substance that may reduce opioid withdrawal symptoms. This was the first clinical trial of noribogaine, ibogaine's active metabolite, in patients established on methadone opioid substitution therapy (OST). In this randomize
Publikováno v:
Clinical Pharmacology in Drug Development
A double‐blind, 4‐period crossover study (NCT01327066) was conducted to assess the effect of the novel norepinephrine prodrug droxidopa on the QT interval in in healthy subjects. Subjects were randomized to receive a single dose of droxidopa 600
Autor:
Armin Schultz, Joachim Scholpp, Wolfgang Timmer, Rüdiger Nave, Stephan Krause, Reinhold Luehmann, Manfred Hartmann, Gezim Lahu
Publikováno v:
Clinical pharmacology in drug development. 1(2)
Teduglutide, an analog of the endogenous hormone glucagon-like peptide-2, is currently being developed for the treatment of short bowel syndrome. This study investigated the potential effects of teduglutide on cardiac conduction and repolarization. S
Publikováno v:
Clinical pharmacology in drug development. 4(6)
Opioid-induced constipation (OIC) is the most common and often a treatment-limiting adverse event (AE) of opioid therapy for chronic pain. Naloxegol (previously NKTR-118), a PEGylated derivative of naloxone that has minimal penetration of the central
Publikováno v:
Clinical pharmacology in drug development. 4(6)
This randomized, double-blind, placebo-controlled, ascending-dose, crossover study evaluated single oral doses of naloxegol (NKTR-118; 8, 15, 30, 60, 125, 250, 500, and 1000 mg), a PEGylated derivative of naloxone, for safety and tolerability, antago