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Also known as Elinzanetant (BAY 3427080) treatment A
Elinzanetant treatment A · 2 trials · 2 indications
elinzanetant administered in the evening 3 hours after a light dinner.
elinzanetant administered in the evening 3 hours after a light dinner.
elinzanetant administered in the evening 3 hours after a light dinner.
AUC: Area under the concentration vs. time curve from zero to infinity after single (first) dose
Cmax: Maximum observed drug concentration in measured matrix after single dose administration
| Arm | Type | Description |
|---|---|---|
| Sequence 1: Treatment A followed by Treatment B | EXPERIMENTAL | Participants receive Treatment A followed by Treatment B in a randomized 2 x 2 crossover design with two treatment periods. |
| Sequence 2: Treatment B followed by Treatment A | EXPERIMENTAL | Participants receive Treatment B followed by Treatment A in a randomized 2 x 2 crossover design with two treatment periods. |
| Participants receive study medication on time point 1 | EXPERIMENTAL | Participants will receive two single doses of elinzanetant in two different treatments in a randomized sequence (Treatment A, Treatment B). |
| Participants receive study medication on time point 2 | EXPERIMENTAL | Participants will receive two single doses of elinzanetant in two different treatments in a randomized sequence (Treatment A, Treatment B). |
| Name | Type | Description |
|---|---|---|
| Elinzanetant (BAY 3427080) treatment A | DRUG | Elinzanetant treatment A is administered orally once daily. |
| Elinzanetant (BAY 3427080) treatment B | DRUG | Elinzanetant treatment B is administered orally once daily. |
| Elinzanetant (BAY3427080) treatment A | DRUG | Single oral dose |
| Elinzanetant (BAY3427080) treatment B | DRUG | Single oral dose |
Inclusion Criteria: * Female participants aged 18 to 65 years (inclusive) at the time of signing informed consent. * Participants must be overtly healthy as determined by the investigator based on medical history, physical examination, vital signs, ECG, and clinical laboratory assessments. * Body w...
Elinzanetant treatment A is an investigational small molecule being studied for vasomotor symptoms as a sex hormone-dependent disorder in women and men. Vasomotor symptoms include hot flashes and night sweats. It is currently in clinical development and is not approved by the FDA.
Elinzanetant treatment A is being developed by Bayer AG, a German pharmaceutical company traded on the OTC market under the ticker BAYRY. The company is conducting clinical trials to evaluate the drug's pharmacokinetics and safety.
Elinzanetant treatment A is in Phase 1 clinical development. A Phase 1 trial has been completed, and the drug remains investigational. It has not been approved for any use.
Elinzanetant treatment A has one completed Phase 1 trial, NCT04845841, titled 'Comparison of the Extent to Which the Drug Given as Two Different Capsule Sizes Becomes Available to the Body.' The trial enrolled 16 healthy female participants aged 40 years and older in Germany.
Elinzanetant treatment A is a formulation of elinzanetant, a small molecule being studied for vasomotor symptoms. The specific 'treatment A' designation refers to a particular capsule size or formulation tested in the Phase 1 bioavailability trial.