TYRA-300-B01: TYRA-300 is an oral, novel potent FGFR 3-selective tyrosine kinase inhibitor that targets tumors that contain activating gene alterations of FGFR3.
Study summary
The purpose of this study is to evaluate the relative bioavailability of capsule and tablet formulations of TYRA-300-B01, and to evaluate the safety, tolerability, and food effect of TYRA-300-B01 tablets in healthy adult participants.
Eligibility
Sex
ALL
Min age
26 Years
Max age
55 Years
Healthy volunteers
Accepted
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 to 32 kg/m\^2 (inclusive)
* Cohorts 1 and 2 ethnicity requirements: none
* Cohort 3 ethnicity requirements: first- or second-generation Japanese participants
Exclusion Criteria:
* Significant history of any hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, immunologic, musculoskeletal disease, or allergic disease (as determined by the Investigator)
* Any ocular condition likely to increase the risk of eye toxicity
* Gastrointestinal disorders that will affect oral administration or absorption of TYRA-300-B01
* Females of child-bearing potential and males who plan to father a child while enrolled in this study
Primary outcome measure(s)
Pharmacokinetics single-dose Cmax — Up to 48 hours post-dose maximum plasma concentration (Cmax)
Pharmacokinetics multiple-dose Cmax — Up to 24 hours post-dose maximum steady-state plasma concentration (Cmax)
Pharmacokinetics multiple-dose Cmin — Up to 24 hours post-dose average steady-state trough plasma concentration (Cmin)
Pharmacokinetics single dose Tmax — Up to 48 hours post-dose time to reach maximum plasma concentration (Tmax)
Pharmacokinetics single and multiple dose AUC — Up to 48 hours post-dose area under the plasma concentration-time curve (AUC)
Pharmacokinetics single dose CL/F — Up to 48 hours post-dose apparent total clearance (CL/F)
Pharmacokinetics single dose Vz/F — Up to 48 hours post-dose apparent volume of distribution (Vz/F)
Pharmacokinetics single dose t1/2 — Up to 48 hours post-dose half-life of TYRA-300
Pharmacokinetics multiple-dose RCmax — Up to 24 hours post-dose accumulation ratio for Cmax (RCmax)
Pharmacokinetics multiple-dose RAUC — Up to 24 hours post-dose accumulation ratio for AUC
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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