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Active (not recruiting) Phase 1 NCT06006702

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

Phase 1 – testing safety in a small group of people
Conditions: Healthy

Sponsor: Tyra Biosciences, Inc

trial.available_in: БГ
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.
Who can participate
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
Australia (1)
Nucleus Network
Melbourne , Victoria
Technical details
Status
Active (not recruiting)
Phase
Phase 1
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
26 Years
Maximum age
55 Years
Healthy volunteers
No
Start date
16.10.2023
Completion date
01.07.2025
Registry ID
NCT06006702
Source
anzctr
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