An Open-Label Study to Investigate the Absorption, Metabolism, and Excretion of [14C]-JNJ-67856633, a MALT1 inhibitor, After a Single Oral Dose in Healthy Male Participants - Absorption, metabolism, and excretion of 14C-labeled JNJ-67856633

Janssen-Cilag0 个研究点目标入组 8 人开始时间: 待定最近更新: 2024年4月15日

适应症

试验速览

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•1. Participant must 18 to 55 years of age, inclusive.
•2. Must be healthy on the basis of physical examination, and medical history,
•performed at screening and predose.
•3. Must be healthy on the basis of clinical laboratory tests performed at
•screening. If the results of the serum chemistry panel or hematology panel are
•outside the normal reference ranges, the participant may be included only if
•the investigator judges the abnormalities or deviations from normal to be not
•clinically significant. This determination must be recorded in the
•participant's source documents and initialed by the investigator. Total
•bilirubin, ALT, AST, and alkaline phosphatase (ALP) must be within normal
•limits at screening.
•4. Participant has estimated glomerular filtration rate (eGFR) >610 mL/min at
•screening as calculated by MDRD formula (Section 10.9, Appendix 9).
•5. Participants must have regular bowel movements (ie, average production of at
•least one stool every 2 days).
•Further criteria apply

•1. History of or current clinically significant medical illness including (but
•not limited to) cardiac arrhythmias or other cardiac disease, hematologic
•disease, coagulation disorders (including any abnormal bleeding or blood
•dyscrasias), 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 suspected or confirmed Coronavirus Disease 2019 (COVID-19) within
•4 weeks before intake of study drug, or tests positive for severe acute
•respiratory syndrome coronavirus 2 (SARS-CoV-2) at admission to the study site.
•3. History of stomach or intestinal surgery or resection, including
•cholecystectomy, that would potentially alter absorption or excretion of orally
•administered drugs (appendectomy and hernia repair will be allowed).
•4. Participants with a removed gallbladder, or with a history of upper
•gastrointestinal (stomach, duodenum) surgery, or with a recent (less than 3
•months prior to screening) episode of gallstones.
•5. Participant has intolerance to lidocaine (Group B only).
•Further criteria apply

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