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

Tyra Biosciences

Status and phase: Active, not recruiting; Phase 1

Conditions: Healthy

Treatments: Drug: TYRA-300-B01

Study type: Interventional

Funder types: Industry

Identifiers

NCT06006702

TYR300-102

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 26 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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60 participants in 4 patient groups

Bioavailability Tablet vs Capsule Formulation

Experimental group

Description:

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

Treatment:

Drug: TYRA-300-B01

Food Effect Tablet Formulation

Experimental group

Description:

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

Treatment:

Drug: TYRA-300-B01

Pharmacokinetic Tablet Formulation

Experimental group

Description:

TYRA-300-B01 single oral dose

Treatment:

Drug: TYRA-300-B01

Pharmacokinetic Mini-Tablet Formulation

Experimental group

Description:

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

Treatment:

Drug: TYRA-300-B01