{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,21]],"date-time":"2026-10-21T16:54:48Z","timestamp":1792601688127,"version":"4.5.0"},"reference-count":20,"publisher":"Wiley","issue":"6","license":[{"start":{"date-parts":[[2020,12,30]],"date-time":"2020-12-30T00:00:00Z","timestamp":1609286400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["accp1.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Clinical Pharm in Drug Dev"],"published-print":{"date-parts":[[2021,6]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>Tuberculosis (TB) continues to be a serious threat to public health throughout the world. Newer treatments are needed that could offer simplified regimens with activity against both drug\u2010sensitive and drug\u2010resistant bacilli, while optimizing safety. Pretomanid (PA\u2010824), a nitroimidazooxazine compound, is a new drug for the treatment of pulmonary TB that was recently approved in the United States and Europe in the context of a regimen combined with bedaquiline and linezolid. This phase 1 double\u2010blind, randomized, placebo\u2010controlled crossover study specifically examined the effect of single\u2010dose administration of pretomanid 400 or 1000\u00a0mg and pretomanid 400\u00a0mg plus moxifloxacin 400\u00a0mg on the QTc interval in 74 healthy subjects. Subjects were fasting at the time of drug administration. Pretomanid concentrations following single 400\u2010 or 1000\u2010mg doses were not associated with any QT interval prolongation of clinical concern. Moxifloxacin did not alter the pharmacokinetics of pretomanid, and the effect of pretomanid 400\u00a0mg plus moxifloxacin 400\u00a0mg on the individually corrected QT interval was consistent with the effect of moxifloxacin alone. Both drugs were generally well tolerated. Although supratherapeutic exposure of pretomanid relative to the now\u2010recommended dosing with food was not achieved, these findings contribute to the favorable assessment of cardiac safety for pretomanid.<\/jats:p>","DOI":"10.1002\/cpdd.898","type":"journal-article","created":{"date-parts":[[2020,12,30]],"date-time":"2020-12-30T23:53:31Z","timestamp":1609372411000},"page":"634-646","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":11,"title":["Phase 1 Study of the Effects of the Tuberculosis Treatment Pretomanid, Alone and in Combination With Moxifloxacin, on the QTc Interval in Healthy Volunteers"],"prefix":"10.1002","volume":"10","author":[{"given":"Mengchun","family":"Li","sequence":"first","affiliation":[{"name":"TB Alliance  New York New York USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"George A.","family":"Saviolakis","sequence":"additional","affiliation":[{"name":"DynPort Vaccine Company (DVC), LLC, a GDIT company  Frederick Maryland USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Wael","family":"El\u2010Amin","sequence":"additional","affiliation":[{"name":"DynPort Vaccine Company (DVC), LLC, a GDIT company  Frederick Maryland USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mamodikoe K.","family":"Makhene","sequence":"additional","affiliation":[{"name":"Division of Microbiology and Infectious Diseases, National Institute of Allergy and Infectious Diseases National Institutes of Health  Bethesda Maryland USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Blaire","family":"Osborn","sequence":"additional","affiliation":[{"name":"Office of Clinical Pharmacology United States Food and Drug Administration  Silver Spring Maryland USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jerry","family":"Nedelman","sequence":"additional","affiliation":[{"name":"TB Alliance  New York New York USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tian J.","family":"Yang","sequence":"additional","affiliation":[{"name":"TB Alliance  New York New York USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Daniel","family":"Everitt","sequence":"additional","affiliation":[{"name":"TB Alliance  New York New York USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2020,12,30]]},"reference":[{"key":"e_1_2_9_2_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(03)14333-4"},{"key":"e_1_2_9_3_1","volume-title":"WHO Global Tuberculosis Report 2020","author":"World Health 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