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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05446142 | A Relative Bioavailability Study Evaluating Two New Encorafenib Formulations | PHASE1 | COMPLETED | 18 | — | — | Jul 1, 2022 | Sep 30, 2022 | Feb 23, 2024 | 1 | United States |
AUCinf for encorafenib eMCC, eMCCL and CAP formulations (75 mg, single dose administration), and for encorafenib eMCC and eMCCL formulations (75 mg, single dose administration) following 5 days of rabeprazole 20 mg daily were calculated by AUClast + (Clast/kel), where AUClast was the area under the plasma concentration-time profile from time zero to last quantifiable concentration, Clast was the predicted plasma concentration at the last quantifiable time point estimated from the log-linear regression analysis, and kel was first-order elimination rate constant.
Cmax for encorafenib eMCC, eMCCL and CAP formulations (75 mg, single dose administration), and for encorafenib eMCC and eMCCL formulations (75 mg, single dose administration) following 5 days of rabeprazole 20 mg daily were observed directly from data.
AUClast for encorafenib eMCC, eMCCL and CAP formulations (75 mg, single dose administration), and for encorafenib eMCC and eMCCL formulations (75 mg, single dose administration) following 5 days of rabeprazole 20 mg daily were calculated using Linear/Log trapezoidal method.
| Arm | Type | Description |
|---|---|---|
| Four Period Treatment Sequence: PPI Effect | EXPERIMENTAL | Participants will receive a single encorafenib dose formulation, a single encorafenib dose of the formulated capsule (CAP), and a single encorafenib dose of the formulation after administration of 20 mg rabeprazole every evening for 5 days. |
| Four Period Treatment Sequence: PPI Effect Second Formulation | EXPERIMENTAL | Participants will receive a single encorafenib dose of the second formulation, a single encorafenib dose of the second formulation, a single encorafenib dose of the formulated capsule (CAP), and a single encorafenib dose of the second formulation after administration of 20 mg rabeprazole every evening for 5 days. |
| Name | Type | Description |
|---|---|---|
| Encorafenib capsule formulation (CAP) | DRUG | A single encorafenib dose of the CAP formulation |
| Encorafenib first formulation | DRUG | first formulation |
| Encorafenib second formulation | DRUG | second formulation |
| Rabeprazole tablet | DRUG | Proton-pump inhibitor |
Inclusion Criteria: * Participants must be male or female of non-childbearing potential of 18 years of age or older, inclusive, at the time of signing the informed consent document. * Male and female participants who are overtly healthy as determined by medical evaluation including medical history,...