OPEN-LABEL, NON-RANDOMIZED STUDY INVESTIGATING THE EXCRETION BALANCE, PHARMACOKINETICS, AND METABOLISM OF A SINGLE INTRAVENOUS DOSE OF [14C]-LABELED RO7223280 IN HEALTHY MALE PARTICIPANTS - Excretion balance, PK, and metabolism of 14C-labeled RO7223280

F. Hoffmann-La Roche Ltd.0 个研究点目标入组 6 人开始时间: 待定最近更新: 2024年4月9日

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•1. History of any clinically significant gastrointestinal, renal, hepatic,
•broncho pulmonary, neurological, psychiatric, cardiovascular, endocrinological,
•hematological or allergic disease, metabolic disorder, cancer, or cirrhosis
•2. Concomitant disease or condition that could interfere with, or treatment of
•which might interfere with, the conduct of the study, or that would, in the
•opinion of the Investigator, pose an unacceptable risk to the participant in
•this study, including but not limited to, any major illness within 1 month
•before the screening examination or any febrile illness within 1 week prior to
•screening and up to first study drug administration
•3. History or evidence of any medical condition potentially altering the
•absorption, distribution, metabolism, or elimination of drugs. Surgical history
•of the gastrointestinal tract affecting gastric motility or altering the
•gastrointestinal tract (with the exception of uncomplicated appendectomy and
•hernia repair)
•4. History or presence of clinically significant ECG abnormalities based on the
•average of the triplicate ECG recordings (e.g., PQ/PR interval * 210 ms, QTcF *
•450 ms) or cardiovascular disease (e.g., cardiac insufficiency, coronary artery
•disease, cardiomyopathy, congestive heart failure, family history of congenital
•long QT syndrome, family history of sudden death)
•5.History of malignancy

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