Overview
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.
Description
This is a Phase 1, multi-cohort trial studying TYRA-300-B01, a novel, potent fibroblast growth factor receptor (FGFR) 3-selective tyrosine kinase inhibitor, in healthy, adult participants. 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
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