epilepsy
Conditions
Interventions
The volunteer receives 14C radiolabelled JNJ-40411813 once, 30 minutes after a
standardized breakfast
Sponsors
Janssen-Cilag
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: 1. Age: 18 (or the legal age of consent in the jurisdiction in which the study is taking place) to 55 years of age, inclusive. 2. Healthy on the basis of physical examination, medical history, vital signs, and 12-lead ECG performed at screening. If there are any abnormalities, they must be considered not clinically relevant, and this determination must be recorded in the participant's source documents and initialed by the investigator. 3. Healthy on the basis of clinical laboratory tests performed at screening. If the results of the serum chemistry panel, hematology, coagulation, or urinalysis 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 or to be appropriate and reasonable for the population under study. This determination must be recorded in the participant's source documents and initialed by the investigator. 4. Blood pressure (after the participant is supine for 5 minutes) between 90 mm and 140 mm Hg systolic, inclusive, and no higher than 90 mm Hg diastolic at screening. If blood pressure is out of range, up to 2 repeated assessments are permitted. 5. Must not have current COVID-19 infection, confirmed by SARS-CoV-2 polymerase chain reaction (PCR), on Day -1. 6. Weight : Body mass index between 18.0 and 30.0 kg/m2 (inclusive), and body weight not less than 50.0 kg. 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 insufficiency, impaired hepatobiliary function (gall bladder removed, has a hepatobiliary shunt, etc), 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. *Participants with childhood asthma that resolved by the age of 12 years are eligible. **Participants with a history of a suicidal attempt at any time in the past, or suicidal ideation within the past year, as measured by the Columbia-Suicide Severity Rating Scale (C-SSRS) baseline/screening version are excluded. 2. Participant has ALT or aspartate aminotransferase values >=1.5x the upper limit of normal (ULN) or total bilirubin >1.5 times the ULN at screening. 3. Creatinine clearance
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Concentrations of JNJ-4041183, and metabolites in plasma. Concentrations of total radioactivity in plasma and whole blood. Amount of JNJ-40411813, and metabolites in urine. Amount of total radioactivity in urine and feces (and samples of duodenal fluid, if feasible). As required, derived PK parameters of JNJ-40411813, and metabolites, and total radioactivity. | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events (AEs), significant changes in vital signs, ECG, safety laboratory results, and C-SSRS | — |
Countries
Netherlands
Outcome results
None listed