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

Sponsor
Tyra Biosciences, Inc
Study ID
NCT06006702
Phase
PHASE1
Status
Active Not Recruiting

Conditions

  • Healthy

Eligibility Criteria

Sex
ALL
Age
26 Years - 55 Years
Healthy Volunteers
Accepted

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.

Study Details

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.

Key Dates

Start date
Oct 16, 2023
Status verified
Mar 2025
Primary completion
May 31, 2025
Completion
Jul 31, 2025

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

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

Primary Outcome Measure

Pharmacokinetics single-dose Cmax [ Time Frame: Up to 48 hours post-dose ]

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