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 radiolabeled small molecule being studied in healthy male participants. It is used in a Phase 1 clinical trial to investigate the drug's absorption, metabolism, and excretion. The study is not intended to treat any disease, as it enrolls healthy volunteers.
14C-JNJ-56136379 is being developed by Johnson & Johnson, a company traded on the New York Stock Exchange under the ticker JNJ. The company is conducting a Phase 1 clinical trial of this radiolabeled small molecule in healthy participants.
14C-JNJ-56136379 is in Phase 1 clinical development. It is an investigational drug, not yet approved by regulatory authorities. The single Phase 1 trial has been completed, and it is not currently in active clinical trials.
14C-JNJ-56136379 has one completed clinical trial, identified as NCT03864601. This Phase 1 study, titled "A Study of (14C) Radiolabeled JNJ-56136379 in Healthy Male Participants," enrolled 6 participants in the United States. The trial was uncontrolled and not randomized or blinded.
14C-JNJ-56136379 is a radiolabeled version of JNJ-56136379, where the carbon-14 isotope is used to track the drug in the body. This radiolabeling is a common technique in clinical pharmacology studies to assess drug absorption, distribution, metabolism, and excretion.