Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
NT-814 · 1 trial · 1 indication
CumAe(Urine): cumulative amount of Total Radioactivity (TR) excreted in urine.
Cum%Ae(Urine): cumulative amount of TR excreted in urine expressed as a percentage of the radioactive dose administered.
CumAe(Faeces): cumulative amount of TR excreted in faeces.
Cum%Ae(Faeces): cumulative amount of TR excreted in faeces expressed as a percentage of the radioactive dose administered.
CumAe(Total): cumulative amount of TR excreted in urine and faeces combined. The radioactivity associated with toilet tissue was also determined, and the results were reported for each subject as a single value for the whole collection period only and included in the calculation of total Ae and % of dose recovered. The data reported for total calculations excluded toilet tissue data for the 0 - 6 hours post-dose to 0 - 456 hours post-dose collection intervals and included toilet tissue data for the 0 - 480 hours post-dose collection interval.
Cum%Ae(Total): cumulative amount of TR excreted in urine and faeces combined expressed as a percentage of the radioactive dose administered. The radioactivity associated with toilet tissue was also determined, and the results were reported for each subject as a single value for the whole collection period only and included in the calculation of total Ae and % of dose recovered. The data reported for total calculations excluded toilet tissue data for the 0 - 6 hours post-dose to 0 - 456 hours post-dose collection intervals and included toilet tissue data for the 0 - 480 hours post-dose collection interval.
| Arm | Type | Description |
|---|---|---|
| Elinzanetant (NT-814, BAY3427080) | EXPERIMENTAL | Subjects received a single dose of 120 mg radioactive labeled elinzanetant (\[14C\]-NT-814) orally. |
| Name | Type | Description |
|---|---|---|
| [14C]-NT-814 | DRUG | 120 mg radioactive labeled elinzanetant (\[14C\]-NT-814) oral suspension containing NMT (not more than) 5.6 MBq (megabecquerel) \[14C\]. |
Inclusion Criteria: * Healthy males * Aged 30 to 65 years inclusive at the time of signing informed consent. * Body mass index (BMI) of 18.0 to 35.0 kg/m\^2, inclusive, as measured at screening. * Must be able to understand the requirement of the study and be willing to participate in the whole stu...
NT-814 is an investigational small molecule being developed by Bayer AG. It is currently in Phase 1 clinical development. The drug has been studied in a completed trial involving healthy male subjects.
NT-814 is being investigated for use in healthy volunteers. The completed Phase 1 trial was a mass balance study of the drug in healthy male subjects. Its intended therapeutic use has not been specified beyond this initial healthy volunteer study.
NT-814 is being developed by Bayer AG, a multinational pharmaceutical company. Bayer's stock is traded over-the-counter under the ticker symbol BAYRY. The drug is currently in Phase 1 clinical development.
NT-814 is in Phase 1 clinical development. The drug has completed one Phase 1 trial, which was a mass balance study. It is still in the early stages of clinical investigation and has not been approved by regulatory authorities.
NT-814 has been studied in one clinical trial, identified as NCT04654897. This was a Phase 1 mass balance study of [14C]-NT-814 oral suspension in healthy male subjects. The trial was completed and enrolled 6 participants in the United Kingdom.
NT-814 and [14C]-NT-814 are related but not identical. [14C]-NT-814 is a radiolabeled form of NT-814 used in the mass balance study to track the drug's absorption, distribution, metabolism, and excretion in the body. The trial specifically used this radiolabeled version.