Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06342700 | A Food Effect and Relative Bioavailability Study of Rilzabrutinib in Healthy Participants | PHASE1 | COMPLETED | 28 | — | — | Mar 25, 2024 | Apr 23, 2024 | Sep 3, 2025 | 1 | United States |
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...