A Phase 1 Study to Evaluate the Relative Bioavailability of Ensitrelvir Granules and 125 mg Tablets, and the Food Effect of Granules (COVID-19)

Shionogi & Co., Ltd.0 个研究点目标入组 28 人开始时间: 2024年12月16日最近更新: 2024年12月27日

试验速览

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•Apparently healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and 12-lead ECG.
•A person with Japanese parents
•Participant must be 18 to 55 years of age inclusive, at the time of signing the ICF.
•BMI >= 18.5 and 30.0 <=
•Male and female

•Presence or History of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, or neurological disorders that may significantly alter the absorption, metabolism, or elimination of drugs; determined to constitute a risk when administering the study intervention or to interfere with the interpretation of data.
•Participants whose systolic blood pressure is outside the range of 90 to 140 mmHg, diastolic blood pressure is outside the range of 50 to 90 mmHg, or pulse rate is outside the range of 50 to 100 bpm at rest at screening or on admission (day -1) and who are considered ineligible for the study by the investigator.
•Any of the following abnormalities at screening or on admission (day -1):
•Total bilirubin: > 1.5 x upper limit of normal (ULN) based on the facility criteria
•Alanine aminotransferase (ALT): > 1.5 x ULN based on the facility criteria
•Aspartate aminotransferase (AST): > 1.5 x ULN based on the facility criteria
•Creatinine clearance (CLcr) (Cockcroft-Gault formula): < 90 mL/min

Pharmacokinetics parameters

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发起方