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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06006702 | A Relative Bioavailability and Food Effect Study of TYRA-300-B01 Capsule and Tablet Formulations in Healthy Adult Participants | PHASE1 | ACTIVE NOT_RECRUITING | 60 | — | — | Oct 16, 2023 | Jul 1, 2025 | Mar 26, 2025 | 1 | Australia |
maximum plasma concentration (Cmax)
maximum steady-state plasma concentration (Cmax)
average steady-state trough plasma concentration (Cmin)
time to reach maximum plasma concentration (Tmax)
area under the plasma concentration-time curve (AUC)
apparent total clearance (CL/F)
apparent volume of distribution (Vz/F)
half-life of TYRA-300
accumulation ratio for Cmax (RCmax)
accumulation ratio for AUC
| Arm | Type | Description |
|---|---|---|
| Bioavailability Tablet vs Capsule Formulation | EXPERIMENTAL | TYRA-300-B01 single oral dose of tablet or capsule crossover followed by twice-daily tablet dosing |
| Food Effect Tablet Formulation | EXPERIMENTAL | TYRA-300-B01 single oral dose of tablet in the fed and fasted state |
| Pharmacokinetic Tablet Formulation | EXPERIMENTAL | TYRA-300-B01 single oral dose |
| Pharmacokinetic Mini-Tablet Formulation | EXPERIMENTAL | TYRA-300-B01 multiple-dose mini-tablet formulation |
| Name | Type | Description |
|---|---|---|
| TYRA-300-B01 | DRUG | TYRA-300 is an oral, novel potent FGFR 3-selective tyrosine kinase inhibitor that targets tumors that contain activating gene alterations of FGFR3. |
Inclusion Criteria: * Males or females of non-childbearing potential, between 18 and 55 years of age * In good health, determined by no clinically significant findings from medical history, 12-lead electrocardiogram (ECG), vital signs, and clinical laboratory assessments * Body mass index (BMI) 18 ...