Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
14C-JNJ-56136379 · 1 trial · 1 indication
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...
14C-JNJ-56136379 is a carbon-14 radiolabeled version of the small molecule JNJ-56136379, developed by Johnson & Johnson. It was studied in a Phase 1 clinical trial in healthy male participants to evaluate how the drug is absorbed, metabolized, and excreted in the body.
14C-JNJ-56136379 is being developed by Johnson & Johnson, which trades on the New York Stock Exchange under the ticker JNJ. The company sponsored the Phase 1 trial of the radiolabeled compound.
14C-JNJ-56136379 is in Phase 1 clinical development. It has completed one Phase 1 trial, NCT03864601, which enrolled six healthy male participants. The drug remains investigational and has not been approved by the FDA.
14C-JNJ-56136379 has been studied in one completed Phase 1 trial, NCT03864601, titled "A Study of (14C) Radiolabeled JNJ-56136379 in Healthy Male Participants." The trial enrolled six healthy male volunteers in the United States and was an uncontrolled, non-randomized study.
14C-JNJ-56136379 is not a therapeutic treatment; it is a radiolabeled research compound used in clinical pharmacology studies. Its only recorded trial was conducted in healthy male volunteers to assess the drug's absorption, metabolism, and excretion profile.