A Phase 1, crossover, open-label study to compare the bioavailability of S-606001 between capsules and tablets and to investigate the food effect with the tablets following a single oral dose in healthy adults aged 18 to 55 years

Shionogi & Co., Ltd.0 个研究点目标入组 23 人开始时间: 2024年7月4日最近更新: 2025年1月27日

适应症

试验速览

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•Individuals between ages of 18 and 55 years (inclusive) at the time of signing informed consent.
•Individuals must be in good health, as determined by a medical history, physical examination, clinical laboratory evaluations, electrocardiogram (ECG).
•Individuals who weigh 40 kg or more with body mass index (BMI) between 18.5 and 30.0 (inclusive).
•Male or female individuals.

•Individuals with a history of any cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking S-606001; or interfering with the interpretation of data.
•Individuals with a history of syncope of unknown cause, sick sinus syndrome, second or third degree atrioventricular block, myocardial infarction, pulmonary congestion, arrhythmia, angina pectoris, QT interval prolonged, or conduction abnormality.
•Individuals with a history of risk factors for Torsade de Pointes (eg, cardiac failure, cardiomyopathy, hypokalemia, family history of long QT syndrome, Brugada syndrome)
•Individuals with a history of any gastrointestinal surgery (eg, gastric and intestinal resections) excluding appendectomy.
•Individuals with or with a chronic history of liver disease.
•Individuals with known abnormalities of the liver or bile ducts, excluding Gilbert's syndrome or asymptomatic gallstones.

Pharmacokinetic evaluation (eg, plasma concentration, Cmax, Tmax, AUC0-last, AUC0-inf, t1/2,z)

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发起方