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

Sponsor
Tyra Biosciences, Inc (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT06006702
Collaborator
(none)
36
Enrollment
3
Arms
9
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Detailed 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
36 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 1, Multi-cohort, Open-label Study 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
Anticipated Study Start Date :
Oct 1, 2023
Anticipated Primary Completion Date :
Jan 1, 2024
Anticipated Study Completion Date :
Jul 1, 2024

Arms and Interventions

Arm Intervention/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.

Outcome Measures

Primary Outcome Measures

  1. Pharmacokinetics single-dose Cmax [Up to 48 hours post-dose]

    maximum plasma concentration (Cmax)

  2. Pharmacokinetics multiple-dose Cmax [Up to 24 hours post-dose]

    maximum steady-state plasma concentration (Cmax)

  3. Pharmacokinetics multiple-dose Cmin [Up to 24 hours post-dose]

    average steady-state trough plasma concentration (Cmin)

  4. Pharmacokinetics single dose Tmax [Up to 48 hours post-dose]

    time to reach maximum plasma concentration (Tmax)

  5. Pharmacokinetics single and multiple dose AUC [Up to 48 hours post-dose]

    area under the plasma concentration-time curve (AUC)

  6. Pharmacokinetics single dose CL/F [Up to 48 hours post-dose]

    apparent total clearance (CL/F)

  7. Pharmacokinetics single dose Vz/F [Up to 48 hours post-dose]

    apparent volume of distribution (Vz/F)

  8. Pharmacokinetics single dose t1/2 [Up to 48 hours post-dose]

    half-life of TYRA-300

  9. Pharmacokinetics multiple-dose RCmax [Up to 24 hours post-dose]

    accumulation ratio for Cmax (RCmax)

  10. Pharmacokinetics multiple-dose RAUC [Up to 24 hours post-dose]

    accumulation ratio for AUC

Secondary Outcome Measures

  1. Safety and tolerability [Initiation of study treatment up to 7-days post treatment]

    number of participants with adverse events (AEs), serious adverse events (SAEs), adverse events of special interest (AESIs) as a measure of safety and tolerability

  2. Safety and tolerability [Initiation of study treatment up to 7-days post treatment]

    Frequency in changes in laboratory parameters and physical signs of toxicity

Eligibility Criteria

Criteria

Ages Eligible for Study:
26 Years to 55 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Tyra Biosciences, Inc

Investigators

  • Study Chair: Hiroomi Tada, M.D., Ph.D., Tyra Biosciences, Inc

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Tyra Biosciences, Inc
ClinicalTrials.gov Identifier:
NCT06006702
Other Study ID Numbers:
  • TYR300-102
First Posted:
Aug 23, 2023
Last Update Posted:
Aug 23, 2023
Last Verified:
Aug 1, 2023
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Aug 23, 2023