A Single-Dose, Open-label, Randomized, Crossover, Multipart, Multicenter Study to Assess the Relative Oral Bioavailability of a JNJ-77242113 Immediate-release Tablet Formulation with Respect to a Solution Formulation and Food Effect of an Immediate-release Tablet Formulation, and to Assess the Relative Oral Bioavailability, Dose Proportionality, and Food Effect of JNJ-77242113 Delayed-release Tablet Formulations in Healthy Participants - JNJ-77242113 food effect and relative bioavailability study

Janssen-Cilag International NV0 个研究点目标入组 82 人开始时间: 待定最近更新: 2024年4月15日

试验速览

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•1. Male or female (18 to 60 years, inclusive at screening).
•2. Healthy on the basis of physical examination, medical history, and vital
•signs, and 12-lead ECG performed at screening and/or before receiving the first
•dose of study intervention.
•3. Healthy on the basis of clinical laboratory tests performed at screening
•and/or before receiving the first dose of study intervention.
•4. Body mass index between 18.0 and 30.0 kg/m2, and body weight not less than
•50.0 kg at screening.
•5. All women must have a negative highly sensitive serum pregnancy test at
•screening and must have a negative urine pregnancy test on Day -1 of Treatment

•1. History of or current clinically significant medical illness including
•cardiac arrhythmias or other cardiac disease, hematologic disease, coagulation
•disorders, lipid abnormalities, significant pulmonary disease, including
•bronchospastic respiratory disease, diabetes mellitus, hepatic or renal
•insufficiency, thyroid disease, neurologic or psychiatric disease,
•infection, or any other illness that the investigator considers should exclude
•the participant or that could interfere with the interpretation of the study
•2. History of malignancy before screening.
•3. Criterion modified per Amendment 1:
•3.1 Criterion modified per Amendment 2:
•3.2 known allergies, hypersensitivity, or intolerance to JNJ-77242113 or its
•known allergies, hypersensitivity, or intolerance to JNJ-77242113 or its
•excipients (IB 2021; IB Addendum 2022), or to NaC10.
•4. History of GI disease including IBD, toxic megacolon, dysplasia,
•gastroesophageal reflux disease, colon cancer, intestinal stenosis, or fistula.
•5. History of surgical resection of the stomach, small or large intestine.

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