A Relative Bioavailability and Food Effect Study of TYRA-300-B01 Capsule and Tablet Formulations in Healthy Adult Participants

Phase 1Active Not RecruitingNCT06006702

Tyra Biosciences, Inc60 enrolled

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

TYRA-300-B01DRUG

TYRA-300 is an oral, novel potent FGFR 3-selective tyrosine kinase inhibitor that targets tumors that contain activating gene alterations of FGFR3.

Eligibility

Sex: ALLMin age: 26 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Nucleus Network

Melbourne, Victoria, Australia

Outcomes

Primary Outcomes

Pharmacokinetics single-dose Cmax

maximum plasma concentration (Cmax)

Time frame: Up to 48 hours post-dose

Pharmacokinetics multiple-dose Cmax

maximum steady-state plasma concentration (Cmax)

Time frame: Up to 24 hours post-dose

Pharmacokinetics multiple-dose Cmin

average steady-state trough plasma concentration (Cmin)

Time frame: Up to 24 hours post-dose

Pharmacokinetics single dose Tmax

time to reach maximum plasma concentration (Tmax)

Time frame: Up to 48 hours post-dose

Pharmacokinetics single and multiple dose AUC

area under the plasma concentration-time curve (AUC)

Time frame: Up to 48 hours post-dose

Pharmacokinetics single dose CL/F

apparent total clearance (CL/F)

Time frame: Up to 48 hours post-dose

Pharmacokinetics single dose Vz/F

apparent volume of distribution (Vz/F)

Time frame: Up to 48 hours post-dose

Pharmacokinetics single dose t1/2

half-life of TYRA-300

Time frame: Up to 48 hours post-dose

Pharmacokinetics multiple-dose RCmax

accumulation ratio for Cmax (RCmax)

Time frame: Up to 24 hours post-dose

Data from ClinicalTrials.gov

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A Relative Bioavailability and Food Effect Study of TYRA-300-B01 Capsule and Tablet Formulations in Healthy Adult Participants

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes