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

NCT06006702 | Active Not Recruiting Phase 1 FDA Drug

• 1 other identifier: TYR300-102
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Healthy

Outcome Measures

Primary Outcomes (10)

• Pharmacokinetics single-dose Cmax

  maximum plasma concentration (Cmax)

  Up to 48 hours post-dose

• Pharmacokinetics multiple-dose Cmax

  maximum steady-state plasma concentration (Cmax)

  Up to 24 hours post-dose

• Pharmacokinetics multiple-dose Cmin

  average steady-state trough plasma concentration (Cmin)

  Up to 24 hours post-dose

• Pharmacokinetics single dose Tmax

  time to reach maximum plasma concentration (Tmax)

  Up to 48 hours post-dose

• Pharmacokinetics single and multiple dose AUC

  area under the plasma concentration-time curve (AUC)

  Up to 48 hours post-dose

• Pharmacokinetics single dose CL/F

  apparent total clearance (CL/F)

  Up to 48 hours post-dose

• Pharmacokinetics single dose Vz/F

  apparent volume of distribution (Vz/F)

  Up to 48 hours post-dose

• Pharmacokinetics single dose t1/2

  half-life of TYRA-300

  Up to 48 hours post-dose

• Pharmacokinetics multiple-dose RCmax

  accumulation ratio for Cmax (RCmax)

  Up to 24 hours post-dose

• Pharmacokinetics multiple-dose RAUC

  accumulation ratio for AUC

  Up to 24 hours post-dose

Secondary Outcomes (2)

• Safety and tolerability

  Initiation of study treatment up to 7-days post treatment

• Safety and tolerability

  Initiation of study treatment up to 7-days post treatment

Study Arms (4)

Bioavailability Tablet vs Capsule Formulation

EXPERIMENTAL

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

Drug: TYRA-300-B01

Food Effect Tablet Formulation

EXPERIMENTAL

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

Drug: TYRA-300-B01

Pharmacokinetic Tablet Formulation

EXPERIMENTAL

TYRA-300-B01 single oral dose

Drug: TYRA-300-B01

Pharmacokinetic Mini-Tablet Formulation

EXPERIMENTAL

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

Drug: TYRA-300-B01

Interventions

TYRA-300-B01 DRUG

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

Bioavailability Tablet vs Capsule Formulation; Food Effect Tablet Formulation; Pharmacokinetic Mini-Tablet Formulation; Pharmacokinetic Tablet Formulation

Eligibility Criteria

• Age: 26 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tyra Biosciences, Inc: lead

Study Sites (1)

Nucleus Network

Melbourne, Victoria, 3004, Australia

Location

Study Officials

• Doug Warner, M.D.

  Tyra Biosciences, Inc

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2023
• First Posted: August 23, 2023
• Study Start: October 16, 2023
• Primary Completion: May 1, 2025
• Study Completion: July 1, 2025
• Last Updated: March 26, 2025

Record last verified: 2025-03

Locations

AU (1)