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, also known as SAR444671, is an investigational small molecule drug developed by Sanofi. It is being studied in clinical development and has been evaluated in a Phase 1 trial. Its therapeutic indications have not been publicly disclosed.
Rilzabrutinib SAR444671 targets Bruton's tyrosine kinase, or BTK. It acts as a BTK inhibitor, meaning it is designed to block the activity of this enzyme. BTK is a signaling molecule involved in certain immune and inflammatory pathways.
Rilzabrutinib SAR444671 is developed by Sanofi, which trades under the ticker SNY. Sanofi is the company responsible for advancing the drug through clinical development.
Rilzabrutinib SAR444671 is in Phase 1 clinical development. It is an investigational drug and is not approved by the FDA. The Phase 1 program has included a completed study in healthy volunteers.
Rilzabrutinib SAR444671 has been studied in the Phase 1 trial NCT04748926, titled Food Effect and Relative Bioavailability Study of Rilzabrutinib in Healthy Participants. That trial was completed and enrolled 24 healthy volunteers in Australia. It was a controlled, randomized study without blinding.
Yes, rilzabrutinib and SAR444671 refer to the same drug. SAR444671 is an alternate designation used for rilzabrutinib, which is developed by Sanofi. Both names identify the same investigational BTK inhibitor.