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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT06006702




Registration number
NCT06006702
Ethics application status
Date submitted
17/08/2023
Date registered
23/08/2023
Date last updated
25/03/2024

Titles & IDs
Public title
A Relative Bioavailability and Food Effect Study of TYRA-300-B01 Capsule and Tablet Formulations in Healthy Adult Participants
Scientific 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
Secondary ID [1] 0 0
TYR300-102
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - TYRA-300-B01

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


Treatment: Drugs: 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 code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Pharmacokinetics single-dose Cmax
Timepoint [1] 0 0
Up to 48 hours post-dose
Primary outcome [2] 0 0
Pharmacokinetics multiple-dose Cmax
Timepoint [2] 0 0
Up to 24 hours post-dose
Primary outcome [3] 0 0
Pharmacokinetics multiple-dose Cmin
Timepoint [3] 0 0
Up to 24 hours post-dose
Primary outcome [4] 0 0
Pharmacokinetics single dose Tmax
Timepoint [4] 0 0
Up to 48 hours post-dose
Primary outcome [5] 0 0
Pharmacokinetics single and multiple dose AUC
Timepoint [5] 0 0
Up to 48 hours post-dose
Primary outcome [6] 0 0
Pharmacokinetics single dose CL/F
Timepoint [6] 0 0
Up to 48 hours post-dose
Primary outcome [7] 0 0
Pharmacokinetics single dose Vz/F
Timepoint [7] 0 0
Up to 48 hours post-dose
Primary outcome [8] 0 0
Pharmacokinetics single dose t1/2
Timepoint [8] 0 0
Up to 48 hours post-dose
Primary outcome [9] 0 0
Pharmacokinetics multiple-dose RCmax
Timepoint [9] 0 0
Up to 24 hours post-dose
Primary outcome [10] 0 0
Pharmacokinetics multiple-dose RAUC
Timepoint [10] 0 0
Up to 24 hours post-dose
Secondary outcome [1] 0 0
Safety and tolerability
Timepoint [1] 0 0
Initiation of study treatment up to 7-days post treatment
Secondary outcome [2] 0 0
Safety and tolerability
Timepoint [2] 0 0
Initiation of study treatment up to 7-days post treatment

Eligibility
Key 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
Minimum age
26 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
16/10/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/07/2024
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Nucleus Network - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Tyra Biosciences, Inc
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT06006702
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Hiroomi Tada, M.D., Ph.D.
Address 0 0
Tyra Biosciences, Inc
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Kate Hogg Call
Address 0 0
Country 0 0
Phone 0 0
(619)728-4805
Fax 0 0
Email 0 0
TyraClinicalTrials@tyra.bio
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT06006702