Search Results - "Täubel, Jörg"

Confirmation of the cardiac safety of nolasiban in a randomised cohort of healthy female volunteers by Täubel, Jörg, Lorch, Ulrike, Spencer, Christopher S., Freier, Anne, Camilleri, Dorothée, Djumanov, Dilshat, Ferber, Georg, Marchand, Line, Gotteland, Jean-Pierre, Pohl, Oliver

“…Nolasiban is an orally active oxytocin receptor antagonist being developed to increase the efficiency of assisted reproductive technologies. This study…”
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Comparing the consistency of electrocardiogram interval measurements by resting ECG versus 12‐lead Holter by Mendzelevski, Boaz, Spencer, Christopher S, Freier, Anne, Camilleri, Dorothée, Graff, Claus, Täubel, Jörg

“…In clinical trials, traditionally only a limited number of 12‐lead resting electrocardiograms (ECGs) can be recorded and, thus, long intervals may elapse…”
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Both osmolality-dependent and independent mechanisms are associated with acute hyperglycemia-induced cardiovascular adverse reactions: Analysis of the mutual interactions leading to cardiovascular phenotypes in dogs by Kambayashi, Ryuichi, Izumi-Nakaseko, Hiroko, Goto, Ai, Takei, Yoshinori, Matsumoto, Akio, Lorch, Ulrike, Täubel, Jörg, Sugiyama, Atsushi

“…Acute hyperglycemia causes various cardiovascular responses; however, the underlying pathophysiology in vivo is myriad and complex, of which mutual…”
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Concentration-effect modeling based on change from baseline to assess the prolonging effect of drugs on QTc together with an estimate of the circadian time course by Ferber, Georg, Wang, Duolao, Täubel, Jörg

“…As ICH E14 was adopted by the US FDA and the EU CPMC in 2005, thorough QT studies have routinely been analyzed by looking at the time‐matched difference…”
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Time- and Race-Specific Haematological Reference Intervals for Healthy Volunteer Trials: A Retrospective Analysis of Pooled Data From Multiple Phase I Trials by Coates, Simon, Wang, Duolao, Pierscionek, Tomasz, Fernandes, Sara, Djumanov, Dilshat, Lorch, Ulrike, Täubel, Jörg

“…Most UK hospitals, laboratories, and research institutions use uniform reference intervals (RI) that do not take into account known diurnal and racial…”
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Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Rising TAK-438 (Vonoprazan) Doses in Healthy Male Japanese/non-Japanese Subjects by Sakurai, Yuuichi, Nishimura, Akira, Kennedy, Gale, Hibberd, Mark, Jenkins, Richard, Okamoto, Hiroyuki, Yoneyama, Tomoki, Jenkins, Helen, Ashida, Kiyoshi, Irie, Shin, Täubel, Jörg

“…To evaluate safety, tolerability, pharmacokinetics, and pharmacodynamics of TAK-438 (vonoprazan, a potassium-competitive acid blocker) in healthy male…”
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Pharmacokinetics, Safety and Cognitive Function Profile of Rupatadine 10, 20 and 40 mg in Healthy Japanese Subjects: A Randomised Placebo-Controlled Trial by Täubel, Jörg, Ferber, Georg, Fernandes, Sara, Lorch, Ulrike, Santamaría, Eva, Izquierdo, Iñaki

“…Rupatadine is a marketed second generation antihistamine, with anti-PAF activity, indicated for symptomatic treatment of allergic rhinitis and urticaria. This…”
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C286, an orally available retinoic acid receptor β agonist drug, regulates multiple pathways to achieve spinal cord injury repair by Goncalves, Maria B, Wu, Yue, Clarke, Earl, Grist, John, Moehlin, Julien, Mendoza-Parra, Marco Antonio, Hobbs, Carl, Kalindjian, Barret, Fok, Henry, Mander, Adrian P, Hassanin, Hana, Bendel, Daryl, Täubel, Jörg, Mant, Tim, Carlstedt, Thomas, Jack, Julian, Corcoran, Jonathan P T

“…Retinoic acid receptor β2 (RARβ2) is an emerging therapeutic target for spinal cord injuries (SCIs) with a unique multimodal regenerative effect. We have…”
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Single Doses up to 800 mg of E-52862 Do Not Prolong the QTc Interval--A Retrospective Validation by Pharmacokinetic-Pharmacodynamic Modelling of Electrocardiography Data Utilising the Effects of a Meal on QTc to Demonstrate ECG Assay Sensitivity by Täubel, Jörg, Ferber, Georg, Lorch, Ulrike, Wang, Duolao, Sust, Mariano, Camm, A John

“…E-52862 is a Sigma-1 receptor antagonist (S1RA) currently under investigation as a potential analgesic medicine. We successfully applied a concentration-effect…”
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Both osmolality-dependent and independent mechanisms are associated with acute hyperglycemia-induced cardiovascular adverse reactions: Analysis of the mutual interactions leading to cardiovascular phenotypes in dogs by Kambayashi, Ryuichi, Izumi-Nakaseko, Hiroko, Goto, Ai, Takei, Yoshinori, Matsumoto, Akio, Lorch, Ulrike, Täubel, Jörg, Sugiyama, Atsushi

“…Acute hyperglycemia causes various cardiovascular responses; however, the underlying pathophysiology in vivo is myriad and complex, of which mutual…”
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Analyzing the relationship of QT interval and exposure to Nitazoxanide, a prospective candidate for influenza antiviral therapy-A formal TQT study by Täubel, Jörg, Lorch, Ulrike, Rossignol, Jean-François, Ferber, Georg, John Camm, A.

“…In this randomized, double‐blind, placebo controlled study, the safety of therapeutic (675 mg) and supra‐therapeutic (2,700 mg) doses of nitazoxanide was…”
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Developing an algorithm to predict NAFLD in clinical trial volunteers-interim report NCT04873258 by Täubel, Jörg, Pimenta, Dominic, Petrie, Aviva, Sulaiman, Lydia, Lorch, Ulrike, Moore, Kevin

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Phase 1 study of the RNA interference therapeutic ALN-HSD in healthy adults and patients with non-alcoholic steatohepatitis by Sanyal, Arun, Täubel, Jörg, Badri, Prajakta, Bond, Sarah, Makarova, Nune, Zhao, Weizhi, Karnik, Satyajit, Kajbaf, Farshad, Olenchock, Benjamin, Friedman, Joshua, Gansner, John

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OS-062 - Phase 1 study of the RNA interference therapeutic ALN-HSD in healthy adults and patients with non-alcoholic steatohepatitis by Sanyal, Arun, Täubel, Jörg, Badri, Prajakta, Bond, Sarah, Makarova, Nune, Zhao, Weizhi, Karnik, Satyajit, Kajbaf, Farshad, Olenchock, Benjamin, Friedman, Joshua, Gansner, John

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A Highly Durable RNAi Therapeutic Inhibitor of PCSK9 by Fitzgerald, Kevin, White, Suellen, Borodovsky, Anna, Bettencourt, Brian R, Strahs, Andrew, Clausen, Valerie, Wijngaard, Peter, Horton, Jay D, Taubel, Jorg, Brooks, Ashley, Fernando, Chamikara, Kauffman, Robert S, Kallend, David, Vaishnaw, Akshay, Simon, Amy

“…In a phase 1 trial, healthy volunteers were assigned to an RNAi therapeutic inhibitor of PCSK9 or placebo. Single doses of 300 mg or more reduced LDL…”
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Phase 1 safety, tolerability, pharmacokinetics and pharmacodynamic results of KCL‐286, a novel retinoic acid receptor‐β agonist for treatment of spinal cord injury, in male healthy participants by Goncalves, Maria B., Mant, Tim, Täubel, Jörg, Clarke, Earl, Hassanin, Hana, Bendel, Daryl, Fok, Henry, Posner, John, Holmes, Jane, Mander, Adrian P., Corcoran, Jonathan P. T.

“…Aims KCL‐286 is an orally available agonist that activates the retinoic acid receptor (RAR) β2, a transcription factor which stimulates axonal outgrowth. The…”
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CRISPR-Cas9 Gene Editing with Nexiguran Ziclumeran for ATTR Cardiomyopathy by Fontana, Marianna, Solomon, Scott D., Kachadourian, Jessica, Walsh, Liron, Rocha, Ricardo, Lebwohl, David, Smith, Derek, Täubel, Jörg, Gane, Edward J., Pilebro, Björn, Adams, David, Razvi, Yousuf, Olbertz, Joy, Haagensen, Alexandra, Zhu, Peijuan, Xu, Yuanxin, Leung, Adia, Sonderfan, Alison, Gutstein, David E., Gillmore, Julian D.

“…Transthyretin amyloidosis with cardiomyopathy (ATTR-CM) is a progressive, often fatal disease. Nexiguran ziclumeran (nex-z) is an investigational therapy based…”
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Novel antisense therapy targeting microRNA-132 in patients with heart failure: results of a first-in-human Phase 1b randomized, double-blind, placebo-controlled study by Täubel, Jörg, Hauke, Wilfried, Rump, Steffen, Viereck, Janika, Batkai, Sandor, Poetzsch, Jenny, Rode, Laura, Weigt, Henning, Genschel, Celina, Lorch, Ulrike, Theek, Carmen, Levin, Arthur A, Bauersachs, Johann, Solomon, Scott D, Thum, Thomas

“…Abstract Aims Cardiac microRNA-132-3p (miR-132) levels are increased in patients with heart failure (HF) and mechanistically drive cardiac remodelling…”
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Pharmacokinetics, safety and tolerability of OBE022, a selective prostaglandin F2α receptor antagonist tocolytic: A first‐in‐human trial in healthy postmenopausal women by Pohl, Oliver, Marchand, Line, Gotteland, Jean‐Pierre, Coates, Simon, Täubel, Jörg, Lorch, Ulrike

“…Aims Preterm birth remains a significant risk for later disability. The selective inhibition of the prostaglandin F2α receptor has significant advantages for a…”
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Practical risk management in early phase clinical trials by Coates, Simon, Täubel, Jörg, Lorch, Ulrike

“…Abstract only…”
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