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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04748926 | Food Effect and Relative Bioavailability Study of Rilzabrutinib in Healthy Participants | PHASE1 | COMPLETED | 24 | — | — | Apr 7, 2021 | May 21, 2021 | Sep 23, 2025 | 1 | Australia |
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...