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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
Trial website
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
[email protected]
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT06006702