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
- Conditions
- chronic lymphocytic leukemiablood cancers10025320Lymphomas
- Registration Number
- NL-OMON50324
- Lead Sponsor
- Janssen-Cilag
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 8
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>-To determine the routes of excretion for JNJ-67856633 after administration of<br /><br>a single oral dose of 14C-JNJ-67856633 in healthy adult male participants.<br /><br>- To characterize the metabolic pathways for JNJ-67856633 and the chemical<br /><br>structure of predominant metabolites after a single oral dose of 300 mg<br /><br>14C-JNJ-67856633 in healthy adult male participants.<br /><br>- To determine the PK of JNJ-67856633 and total radioactivity in plasma, whole<br /><br>blood (total radioactivity only), urine, feces (total radioactivity only), and<br /><br>duodenal fluid after administration of a single oral dose of 14C-JNJ-67856633<br /><br>in healthy adult male participants.</p><br>
- Secondary Outcome Measures
Name Time Method <p>- To characterize the safety and tolerability of a single oral dose of 300 mg<br /><br>14C-JNJ-67856633 in healthy adult male participants.</p><br>