Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
rilzabrutinib SAR444671 · 1 trial · 1 indication
maximun plasma concentration
time to maximum plasma concentration
area under the plasma concentration-time curve from zero to the last measurable concentration
area under the plasma concentration-time curve from zero to infinity
terminal elimination phase half-life
maximun plasma concentration
time to maximum plasma concentration
area under the plasma concentration-time curve from zero to the last measurable concentration
area under the plasma concentration-time curve from zero to infinity
terminal elimination phase half-life
| Arm | Type | Description |
|---|---|---|
| Group 1 | EXPERIMENTAL | Participants will receive caplets after fast (treatment A) on Day 1 and caplets after meal (treatment B) on day 6, and then receive either oral formulation 1 tablets after fast (treatment C) or oral formulation 2 tablets after fast (treatment D) on day 11. |
| Group 2 | EXPERIMENTAL | Participants will receive caplets after meal (treatment B) on Day 1 and caplets after fast (treatment A) on day 6, and then receive either oral formulation 1 tablets after fast (treatment C) or oral formulation 2 tablets after fast (treatment D) on day 11. |
| Name | Type | Description |
|---|---|---|
| rilzabrutinib SAR444671 | DRUG | Pharmaceutical form: caplet Route of administration: oral |
Inclusion criteria : \- Participants who are overtly healthy as determined by medical evaluation * Body mass index (BMI) within the range ≥18 and ≤31 kg/m2 (inclusive) and a minimum body weight of 45 kg. * Female participant is eligible to participate if she is not pregnant or breastfeeding * Male...
Rilzabrutinib SAR444671 is an investigational small molecule being studied in healthy volunteers. Its current clinical development focuses on evaluating the drug's properties in healthy participants rather than treating a specific disease. The drug is in Phase 1 clinical development and is not approved for any indication.
Rilzabrutinib SAR444671 is being 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 pharmacokinetics in healthy volunteers.
Rilzabrutinib SAR444671 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The drug has received FDA designations including Orphan Drug and Fast Track, though it remains in early-stage clinical testing.
Rilzabrutinib SAR444671 has one completed Phase 1 clinical trial registered as NCT04748926, titled "Food Effect and Relative Bioavailability Study of Rilzabrutinib in Healthy Participants." This randomized, controlled study enrolled 24 healthy volunteers in Australia and evaluated the drug's food effect and relative bioavailability.
No, rilzabrutinib SAR444671 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. While it has received Orphan Drug and Fast Track designations from the FDA, these designations do not indicate approval and the drug remains under clinical investigation.