xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06006702</url>
    </required_header>
    <id_info>
      <org_study_id>TYR300-102</org_study_id>
      <nct_id>NCT06006702</nct_id>
    </id_info>
    <brief_title>A Relative Bioavailability and Food Effect Study of TYRA-300-B01 Capsule and Tablet Formulations in Healthy Adult Participants</brief_title>
    <official_title>A Phase 1, Multi-cohort, Open-label Study 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</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Tyra Biosciences, Inc</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Tyra Biosciences, Inc</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The purpose of this study is to evaluate the relative bioavailability of capsule and tablet&#xD;
        formulations of TYRA-300-B01, and to evaluate the safety, tolerability, and food effect of&#xD;
        TYRA-300-B01 tablets in healthy adult participants.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This is a Phase 1, multi-cohort trial studying TYRA-300-B01, a novel, potent fibroblast&#xD;
        growth factor receptor (FGFR) 3-selective tyrosine kinase inhibitor, in healthy, adult&#xD;
        participants. The purpose of this study is to evaluate the relative bioavailability of&#xD;
        capsule and tablet formulations of TYRA-300-B01, and to evaluate the safety, tolerability,&#xD;
        and food effect of TYRA-300-B01 tablets in healthy adult participants.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 2023</start_date>
    <completion_date type="Anticipated">July 2024</completion_date>
    <primary_completion_date type="Anticipated">January 2024</primary_completion_date>
    <phase>Phase 1</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Crossover Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Pharmacokinetics single-dose Cmax</measure>
      <time_frame>Up to 48 hours post-dose</time_frame>
      <description>maximum plasma concentration (Cmax)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Pharmacokinetics multiple-dose Cmax</measure>
      <time_frame>Up to 24 hours post-dose</time_frame>
      <description>maximum steady-state plasma concentration (Cmax)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Pharmacokinetics multiple-dose Cmin</measure>
      <time_frame>Up to 24 hours post-dose</time_frame>
      <description>average steady-state trough plasma concentration (Cmin)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Pharmacokinetics single dose Tmax</measure>
      <time_frame>Up to 48 hours post-dose</time_frame>
      <description>time to reach maximum plasma concentration (Tmax)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Pharmacokinetics single and multiple dose AUC</measure>
      <time_frame>Up to 48 hours post-dose</time_frame>
      <description>area under the plasma concentration-time curve (AUC)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Pharmacokinetics single dose CL/F</measure>
      <time_frame>Up to 48 hours post-dose</time_frame>
      <description>apparent total clearance (CL/F)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Pharmacokinetics single dose Vz/F</measure>
      <time_frame>Up to 48 hours post-dose</time_frame>
      <description>apparent volume of distribution (Vz/F)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Pharmacokinetics single dose t1/2</measure>
      <time_frame>Up to 48 hours post-dose</time_frame>
      <description>half-life of TYRA-300</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Pharmacokinetics multiple-dose RCmax</measure>
      <time_frame>Up to 24 hours post-dose</time_frame>
      <description>accumulation ratio for Cmax (RCmax)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Pharmacokinetics multiple-dose RAUC</measure>
      <time_frame>Up to 24 hours post-dose</time_frame>
      <description>accumulation ratio for AUC</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Safety and tolerability</measure>
      <time_frame>Initiation of study treatment up to 7-days post treatment</time_frame>
      <description>number of participants with adverse events (AEs), serious adverse events (SAEs), adverse events of special interest (AESIs) as a measure of safety and tolerability</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Safety and tolerability</measure>
      <time_frame>Initiation of study treatment up to 7-days post treatment</time_frame>
      <description>Frequency in changes in laboratory parameters and physical signs of toxicity</description>
    </secondary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">36</enrollment>
    <condition>Healthy</condition>
    <arm_group>
      <arm_group_label>Bioavailability Tablet vs Capsule Formulation</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>TYRA-300-B01 single oral dose of tablet or capsule crossover followed by twice-daily tablet dosing</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Food Effect Tablet Formulation</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>TYRA-300-B01 single oral dose of tablet in the fed and fasted state</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Pharmacokinetic Tablet Formulation</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>TYRA-300-B01 single oral dose</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>TYRA-300-B01</intervention_name>
      <description>TYRA-300 is an oral, novel potent FGFR 3-selective tyrosine kinase inhibitor that targets tumors that contain activating gene alterations of FGFR3.</description>
      <arm_group_label>Bioavailability Tablet vs Capsule Formulation</arm_group_label>
      <arm_group_label>Food Effect Tablet Formulation</arm_group_label>
      <arm_group_label>Pharmacokinetic Tablet Formulation</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Males or females of non-childbearing potential, between 18 and 55 years of age&#xD;
  &#xD;
            -  In good health, determined by no clinically significant findings from medical history,&#xD;
               12-lead electrocardiogram (ECG), vital signs, and clinical laboratory assessments&#xD;
  &#xD;
            -  Body mass index (BMI) 18 to 32 kg/m^2 (inclusive)&#xD;
  &#xD;
            -  Cohorts 1 and 2 ethnicity requirements: none&#xD;
  &#xD;
            -  Cohort 3 ethnicity requirements: first- or second-generation Japanese participants&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Significant history of any hematological, renal, endocrine, pulmonary,&#xD;
               gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, immunologic,&#xD;
               musculoskeletal disease, or allergic disease (as determined by the Investigator)&#xD;
  &#xD;
            -  Any ocular condition likely to increase the risk of eye toxicity&#xD;
  &#xD;
            -  Gastrointestinal disorders that will affect oral administration or absorption of&#xD;
               TYRA-300-B01&#xD;
  &#xD;
            -  Females of child-bearing potential and males who plan to father a child while enrolled&#xD;
               in this study&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>26 Years</minimum_age>
      <maximum_age>55 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Hiroomi Tada, M.D., Ph.D.</last_name>
      <role>Study Chair</role>
      <affiliation>Tyra Biosciences, Inc</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Kate Hogg Call</last_name>
      <phone>(619)728-4805</phone>
      <email>TyraClinicalTrials@tyra.bio</email>
    </overall_contact>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 17, 2023</study_first_submitted>
    <study_first_submitted_qc>August 17, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 23, 2023</study_first_posted>
    <last_update_submitted>August 17, 2023</last_update_submitted>
    <last_update_submitted_qc>August 17, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 23, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06006702
  org study id: TYR300-102
  nct id: NCT06006702
  lead sponsor: 
  has dmc: No
  is fda regulated drug: Yes
  is fda regulated device: No
  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.
  allocation: Randomized
  intervention model: Crossover Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Pharmacokinetics single-dose Cmax
  time frame: Up to 48 hours post-dose
  description: maximum plasma concentration (Cmax)
  measure: Pharmacokinetics multiple-dose Cmax
  time frame: Up to 24 hours post-dose
  description: maximum steady-state plasma concentration (Cmax)
  measure: Pharmacokinetics multiple-dose Cmin
  time frame: Up to 24 hours post-dose
  description: average steady-state trough plasma concentration (Cmin)
  measure: Pharmacokinetics single dose Tmax
  time frame: Up to 48 hours post-dose
  description: time to reach maximum plasma concentration (Tmax)
  measure: Pharmacokinetics single and multiple dose AUC
  time frame: Up to 48 hours post-dose
  description: area under the plasma concentration-time curve (AUC)
  measure: Pharmacokinetics single dose CL/F
  time frame: Up to 48 hours post-dose
  description: apparent total clearance (CL/F)
  measure: Pharmacokinetics single dose Vz/F
  time frame: Up to 48 hours post-dose
  description: apparent volume of distribution (Vz/F)
  measure: Pharmacokinetics single dose t1/2
  time frame: Up to 48 hours post-dose
  description: half-life of TYRA-300
  measure: Pharmacokinetics multiple-dose RCmax
  time frame: Up to 24 hours post-dose
  description: accumulation ratio for Cmax (RCmax)
  measure: Pharmacokinetics multiple-dose RAUC
  time frame: Up to 24 hours post-dose
  description: accumulation ratio for AUC
  measure: Safety and tolerability
  time frame: Initiation of study treatment up to 7-days post treatment
  description: number of participants with adverse events (AEs), serious adverse events (SAEs), adverse events of special interest (AESIs) as a measure of safety and tolerability
  measure: Safety and tolerability
  time frame: Initiation of study treatment up to 7-days post treatment
  description: Frequency in changes in laboratory parameters and physical signs of toxicity
  arm group label: Bioavailability Tablet vs Capsule Formulation
  arm group type: Experimental
  description: TYRA-300-B01 single oral dose of tablet or capsule crossover followed by twice-daily tablet dosing
  arm group label: Food Effect Tablet Formulation
  arm group type: Experimental
  description: TYRA-300-B01 single oral dose of tablet in the fed and fasted state
  arm group label: Pharmacokinetic Tablet Formulation
  arm group type: Experimental
  description: TYRA-300-B01 single oral dose
  intervention type: Drug
  intervention name: TYRA-300-B01
  description: TYRA-300 is an oral, novel potent FGFR 3-selective tyrosine kinase inhibitor that targets tumors that contain activating gene alterations of FGFR3.
  arm group label: Bioavailability Tablet vs Capsule Formulation
  arm group label: Food Effect Tablet Formulation
  arm group label: Pharmacokinetic Tablet Formulation
  criteria: 
  gender: All
  minimum age: 26 Years
  maximum age: 55 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Hiroomi Tada, M.D., Ph.D.
  role: Study Chair
  affiliation: Tyra Biosciences, Inc
  last name: Kate Hogg Call
  phone: (619)728-4805
  email: TyraClinicalTrials@tyra.bio
  responsible party type: Sponsor