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

NCT ID: NCT06006702

Last Updated: 2025-03-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-16

Study Completion Date

2025-07-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Bioavailability Tablet vs Capsule Formulation

TYRA-300-B01 single oral dose of tablet or capsule crossover followed by twice-daily tablet dosing

Group Type EXPERIMENTAL

TYRA-300-B01

Intervention Type DRUG

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

Food Effect Tablet Formulation

TYRA-300-B01 single oral dose of tablet in the fed and fasted state

Group Type EXPERIMENTAL

TYRA-300-B01

Intervention Type DRUG

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

Pharmacokinetic Tablet Formulation

TYRA-300-B01 single oral dose

Group Type EXPERIMENTAL

TYRA-300-B01

Intervention Type DRUG

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

Pharmacokinetic Mini-Tablet Formulation

TYRA-300-B01 multiple-dose mini-tablet formulation

Group Type EXPERIMENTAL

TYRA-300-B01

Intervention Type DRUG

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

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

26 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Tyra Biosciences, Inc

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Doug Warner, M.D.

Role: STUDY_CHAIR

Tyra Biosciences, Inc

Locations

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Nucleus Network

Melbourne, Victoria, Australia

Site Status

Countries

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Australia

Other Identifiers

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TYR300-102

Identifier Type: -

Identifier Source: org_study_id

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