Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 53718678RSV1008 | Other Identifier | Janssen Research & Development, LLC | |
| 2016-002664-14 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of the study is to determine the routes of excretion for JNJ-53718678 and its metabolites, to explore the metabolic pathways of JNJ-53718678, and to determine the chemical structure of predominant metabolites in healthy adult male participants after a single oral dose of 500 milligram (mg) 14C-JNJ-53718678.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| JNJ-53718678 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JNJ-53718678 | Drug | Participants will receive a single 500 milligram (mg) dose of 14C-JNJ-53718678 as an oral liquid solution containing 14C-labeled and unlabeled JNJ-53718678 corresponding to a radioactivity dose. |
| Measure | Description | Time Frame |
|---|---|---|
| Mass Balance of JNJ-53718678 in Healthy Adult Male Participants. | Total mass balance calculated by D(dose) urine, total (percent [%]) + D feces, total (%) + D duodenal, total (%) where D urine, total is the total percentage of the dose excreted into urine, calculated as 100 * (Ae total [total amount excreted into urine, calculated by adding the amounts of the individual intervals together] /Dose); D feces,total is the total percentage of the dose excreted into feces, calculated as 100 * (Ae total [total amount excreted into feces, calculated by adding the amounts of the individual stools together]/Dose) and D duodenal, total is defined as total percentage of the dose collected in all duodenal samples collectively, calculated as % of dose. | Up to Day 10 |
| Metabolic profiles of JNJ-53718678 in plasma, duodenal fluid, urine, and feces samples with radio high-performance liquid chromatography analysis | Metabolite profiling will be performed with radio high-performance liquid chromatography. | Up to Day 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events as a Measure of Safety and Tolerability | Safety and Tolerability | Throughout the study duration (up to 24 days) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PRA Health Sciences Onderzoekscentrum Groningen, locatie Martini | Groningen | 9728 NZ | Netherlands |
Not provided
| ID | Term |
|---|---|
| C000624632 | JNJ-53718678 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided