Healthy
Conditions
Brief 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.
Detailed 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.
Interventions
DRUGTYRA-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.
Sponsors
Tyra Biosciences, Inc
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
26 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics multiple-dose RAUC | Up to 24 hours post-dose | accumulation ratio for AUC |
| 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety and tolerability | Initiation of study treatment up to 7-days post treatment | number of participants with adverse events (AEs), serious adverse events (SAEs), adverse events of special interest (AESIs) as a measure of safety and tolerability |
Countries
Australia
Outcome results
None listed