chronic lymphocytic leukemia blood cancers Lymphomas
Conditions
Interventions
Screening | Arrival | In-house stay | Departure |
Visits*
Day -21 up to Day -2 Day -1 Day -1 up to Day 15 | Day 15 | Day 22 Day 29
Day 36 Day 43
* These visits are only needed if the volunteer did n
Sponsors
Janssen-Cilag
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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 results. 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| -To determine the routes of excretion for JNJ-67856633 after administration of a single oral dose of 14C-JNJ-67856633 in healthy adult male participants. - To characterize the metabolic pathways for JNJ-67856633 and the chemical structure of predominant metabolites after a single oral dose of 300 mg 14C-JNJ-67856633 in healthy adult male participants. - To determine the PK of JNJ-67856633 and total radioactivity in plasma, whole blood (total radioactivity only), urine, feces (total radioactivity only), and duodenal fluid after administration of a single oral dose of 14C-JNJ-67856633 in healthy adult male participants. | — |
Secondary
| Measure | Time frame |
|---|---|
| - To characterize the safety and tolerability of a single oral dose of 300 mg 14C-JNJ-67856633 in healthy adult male participants. | — |
Countries
Netherlands
Outcome results
None listed