Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Rilzabrutinib crystalline form · 1 trial · 2 indications
Cmax: maximum plasma concentration
AUClast: area under the plasma concentration versus time curve from time zero to the last measurable concentration
AUC: area under the plasma concentration versus time curve extrapolated to infinity
| Arm | Type | Description |
|---|---|---|
| Treatment A: SAR444671 amorphous fasted | ACTIVE_COMPARATOR | Participants will receive single oral dose of amorphous tablet formulation rilzabrutinib (SAR444671) under fasted conditions on Day 1 for one period |
| Treatment B: SAR444671 crystalline fasted | EXPERIMENTAL | Participants will receive single oral dose of crystalline tablet formulation rilzabrutinib (SAR444671) under fasted conditions on Day 1 for one period |
| Treatment C: SAR444671 amorphous fed | ACTIVE_COMPARATOR | Participants will receive single oral dose of amorphous tablet formulation rilzabrutinib (SAR444671) under fed conditions on Day 1 for one period |
| Treatment D: SAR444671 crystalline fed | EXPERIMENTAL | Participants will receive single oral dose of crystalline tablet formulation rilzabrutinib (SAR444671) under fed conditions on Day 1 for one period |
| Name | Type | Description |
|---|---|---|
| Rilzabrutinib crystalline form | DRUG | Pharmaceutical form:Film coated tablet Route of administration:Oral |
| Rilzabrutinib amorphous form | DRUG | Pharmaceutical form:Film coated tablet Route of administration:Oral |
Inclusion Criteria: * Body weight between 50.0 and 100.0 kg, inclusive, if male, and between 40.0 and 90.0 kg, inclusive, if female, body mass index (BMI) between 18.0 and 32.0 kg/m2, inclusive * Laboratory parameters within the normal range, unless the Investigator considers an abnormality to be c...
Rilzabrutinib crystalline form is an investigational small molecule being developed by Sanofi for the treatment of autoimmune disorders. It is currently in Phase 1 clinical development. The drug has received Orphan Drug and Fast Track designations from the FDA, indicating its potential to address serious conditions with unmet medical needs.
Rilzabrutinib crystalline form is a small molecule designed to treat autoimmune disorders. While the specific molecular target is not disclosed in the available information, the drug is being studied for its effects on the immune system. It has received Orphan Drug and Fast Track designations from the FDA for its potential in treating these conditions.
Rilzabrutinib crystalline form is developed by Sanofi, a global biopharmaceutical company listed on the stock exchange under the ticker SNY. Sanofi is conducting clinical trials to evaluate the drug's safety and efficacy in treating autoimmune disorders. The drug is currently in Phase 1 development.
Rilzabrutinib crystalline form is in Phase 1 clinical development. It is an investigational drug being studied for the treatment of autoimmune disorders. The drug has received Orphan Drug and Fast Track designations from the FDA, but it is not yet approved for any use. Clinical trials are ongoing to assess its safety and efficacy.
Rilzabrutinib crystalline form has one completed Phase 1 clinical trial, NCT06342700, which studied the drug's food effect and relative bioavailability in healthy participants. The trial enrolled 28 participants in the United States and was active-controlled. The drug is being developed for autoimmune disorders and has received Orphan Drug and Fast Track designations.
Rilzabrutinib crystalline form is a specific crystalline form of the drug rilzabrutinib. The crystalline form is being developed by Sanofi for autoimmune disorders and is in Phase 1 clinical trials. The drug has received Orphan Drug and Fast Track designations from the FDA. The crystalline form may have different properties compared to other forms of rilzabrutinib.