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

PHASE1RECRUITING

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.

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Study details:

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.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

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
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    Eligibility

    Age eligible for study : 26 and older

    Healthy volunteers accepted : Yes

    Gender eligible for study: All

    Things to know

    Study dates

    Study start: 2023-10-16

    Primary completion: 2024-05-01

    Study completion finish: 2024-07-01

    study type

    Study type

    TREATMENT

    phase

    Phase

      PHASE1

    trial

    Trial ID

    NCT06006702

    Intervention or treatment

    DRUG: TYRA-300-B01

    Conditions

    • Healthy

    Find a site

    Closest Location:

    Nucleus Network

    Research sites nearby

    Select from list below to view details:

    • Nucleus Network

      Melbourne, Victoria, Australia

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    Study Plan

    This section provides details of the study plan, including how the study is designed and what the study is measuring.

    How is the study designed?

    Participant Group/ArmIntervention/Treatment
    EXPERIMENTAL: Bioavailability Tablet vs Capsule Formulation
    • TYRA-300-B01 single oral dose of tablet or capsule crossover followed by twice-daily tablet dosing
    DRUG: TYRA-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.
    EXPERIMENTAL: Food Effect Tablet Formulation
    • TYRA-300-B01 single oral dose of tablet in the fed and fasted state
    DRUG: TYRA-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.
    EXPERIMENTAL: Pharmacokinetic Tablet Formulation
    • TYRA-300-B01 single oral dose
    DRUG: TYRA-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.
    EXPERIMENTAL: Pharmacokinetic Mini-Tablet Formulation
    • TYRA-300-B01 multiple-dose mini-tablet formulation
    DRUG: TYRA-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.

    What is the study measuring?

    Primary outcome

    Primary Outcome MeasurePrimary Outcome DescriptionPrimary Outcome Time Frame
    Pharmacokinetics single-dose Cmaxmaximum plasma concentration (Cmax)Up to 48 hours post-dose
    Pharmacokinetics multiple-dose Cmaxmaximum steady-state plasma concentration (Cmax)Up to 24 hours post-dose
    Pharmacokinetics multiple-dose Cminaverage steady-state trough plasma concentration (Cmin)Up to 24 hours post-dose
    Pharmacokinetics single dose Tmaxtime to reach maximum plasma concentration (Tmax)Up to 48 hours post-dose
    Pharmacokinetics single and multiple dose AUCarea under the plasma concentration-time curve (AUC)Up to 48 hours post-dose
    Pharmacokinetics single dose CL/Fapparent total clearance (CL/F)Up to 48 hours post-dose
    Pharmacokinetics single dose Vz/Fapparent volume of distribution (Vz/F)Up to 48 hours post-dose
    Pharmacokinetics single dose t1/2half-life of TYRA-300Up to 48 hours post-dose
    Pharmacokinetics multiple-dose RCmaxaccumulation ratio for Cmax (RCmax)Up to 24 hours post-dose
    Pharmacokinetics multiple-dose RAUCaccumulation ratio for AUCUp to 24 hours post-dose

    Secondary outcome

    Secondary Outcome MeasureSecondary Outcome DescriptionSecondary Outcome Time Frame
    Safety and tolerabilitynumber of participants with adverse events (AEs), serious adverse events (SAEs), adverse events of special interest (AESIs) as a measure of safety and tolerabilityInitiation of study treatment up to 7-days post treatment
    Safety and tolerabilityFrequency in changes in laboratory parameters and physical signs of toxicityInitiation of study treatment up to 7-days post treatment

    Frequently Asked Questions

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    References

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

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