Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03864601 | A Study of (14C) Radiolabeled JNJ-56136379 in Healthy Male Participants | PHASE1 | COMPLETED | 6 | — | — | Apr 9, 2019 | Jun 14, 2019 | Feb 3, 2025 | 1 | United States |
Ratio of JNJ-56136379 concentration (plasma) and total radioactivity (plasma) for maximum observed plasma concentration (Cmax) will be assessed.
Ratio of JNJ-56136379 concentration (plasma) and total radioactivity (plasma) for area under the plasma concentration-time curve from time zero to last quantifiable concentration time (AUC\[0-last\]) will be assessed.
Ratio of JNJ-56136379 concentration (plasma) and total radioactivity (plasma) for area under the plasma concentration- time curve from time zero to infinite time (AUC \[0-infinity\]) will be assessed.
The total radioactivity of 14C-JNJ-56136379 in the whole blood plasma, feces and urine will be calculated.
The amount of 14C-JNJ-56136379 recovered from the total administered radioactive dose in the feces and urine will be calculated.
| Arm | Type | Description |
|---|---|---|
| 14C-JNJ-56136379 | EXPERIMENTAL | Participants will receive a single oral 25 milligram (mg) dose of 14C-JNJ-56136379 on Day 1 under fed conditions. |
| Name | Type | Description |
|---|---|---|
| 14C-JNJ-56136379 | DRUG | 14C-JNJ-56136379 25 mg dose formulated as a polyethylene glycol (PEG)-based oral solution containing 3,145 kilo Becquerel (kBq) of 14C labeled JNJ-56136379, with a maximal total radiation burden of 1,000 micro Sievert. |
Inclusion Criteria: * During the study (from the day of study drug intake onwards) and for a minimum of 1 spermatogenesis cycle (defined as approximately 90 days) after receiving study drug, a male participant: must agree: (a) to wear a condom when engaging in any activity that allows for passage o...