HealthyPhase 1NCT06006702
A Relative Bioavailability and Food Effect Study of TYRA-300-B01 Capsule and Tablet Formulations in Healthy Adult Participants
A Phase 1 study testing TYRA-300-B01 in people with Healthy, run by Tyra Biosciences, Inc at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 26 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- TYRA-300-B01
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteAustralia
- Study dates
- 16 Oct 2023to Jul 2025
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 26 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Healthy
- Being tested
- TYRA-300-B01
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TYRA-300-B01Drug
TYRA-300 is an oral, novel potent FGFR 3-selective tyrosine kinase inhibitor that targets tumors that contain activating gene alterations of FGFR3.
| Study group | Role | What they receive |
|---|---|---|
| Bioavailability Tablet vs Capsule Formulation | Experimental | TYRA-300-B01 single oral dose of tablet or capsule crossover followed by twice-daily tablet dosing Receives: Drug: TYRA-300-B01 |
| Food Effect Tablet Formulation | Experimental | TYRA-300-B01 single oral dose of tablet in the fed and fasted state Receives: Drug: TYRA-300-B01 |
| Pharmacokinetic Tablet Formulation | Experimental | TYRA-300-B01 single oral dose Receives: Drug: TYRA-300-B01 |
| Pharmacokinetic Mini-Tablet Formulation | Experimental | TYRA-300-B01 multiple-dose mini-tablet formulation Receives: Drug: TYRA-300-B01 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics single-dose Cmax
maximum plasma concentration (Cmax)
Measured: Up to 48 hours post-dose
Pharmacokinetics multiple-dose Cmax
maximum steady-state plasma concentration (Cmax)
Measured: Up to 24 hours post-dose
Pharmacokinetics multiple-dose Cmin
average steady-state trough plasma concentration (Cmin)
Measured: Up to 24 hours post-dose
Pharmacokinetics single dose Tmax
time to reach maximum plasma concentration (Tmax)
Measured: Up to 48 hours post-dose
Pharmacokinetics single and multiple dose AUC
area under the plasma concentration-time curve (AUC)
Measured: Up to 48 hours post-dose
Pharmacokinetics single dose CL/F
apparent total clearance (CL/F)
Measured: Up to 48 hours post-dose
Pharmacokinetics single dose Vz/F
apparent volume of distribution (Vz/F)
Measured: Up to 48 hours post-dose
Pharmacokinetics single dose t1/2
half-life of TYRA-300
Measured: Up to 48 hours post-dose
Pharmacokinetics multiple-dose RCmax
accumulation ratio for Cmax (RCmax)
Measured: Up to 24 hours post-dose
Pharmacokinetics multiple-dose RAUC
accumulation ratio for AUC
Measured: Up to 24 hours post-dose
Secondary outcomes (2)
Safety and tolerability
number of participants with adverse events (AEs), serious adverse events (SAEs), adverse events of special interest (AESIs) as a measure of safety and tolerability
Measured: Initiation of study treatment up to 7-days post treatment
Safety and tolerability
Frequency in changes in laboratory parameters and physical signs of toxicity
Measured: Initiation of study treatment up to 7-days post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2023
- Study start16 Oct 2023
- Primary completionMay 2025 (estimated)
- Study completionJul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tyra Biosciences, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Doug Warner, M.D., Study chair, Tyra Biosciences, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06006702
- Sponsor's protocol ID
- TYR300-102
- Status last verified
- Mar 2025
- First submitted
- 17 Aug 2023
- Last updated
- 26 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06006702
- Acronym / sponsor ID
- TYR300-102
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Tyra Biosciences, IncIndustry (pharma, biotech, devices)
- Study start
- 16 Oct 2023 (actual)
- Primary completion
- May 2025 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 23 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Bioavailability Tablet vs Capsule Formulation | Experimental | Drug: TYRA-300-B01TYRA-300-B01 single oral dose of tablet or capsule crossover followed by twice-daily tablet dosing |
| Food Effect Tablet Formulation | Experimental | Drug: TYRA-300-B01TYRA-300-B01 single oral dose of tablet in the fed and fasted state |
| Pharmacokinetic Tablet Formulation | Experimental | Drug: TYRA-300-B01TYRA-300-B01 single oral dose |
| Pharmacokinetic Mini-Tablet Formulation | Experimental | Drug: TYRA-300-B01TYRA-300-B01 multiple-dose mini-tablet formulation |
Who may qualify
- Ages
- 26 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TYRA-300-B01TYRA-300 is an oral, novel potent FGFR 3-selective tyrosine kinase inhibitor that targets tumors that contain activating gene alterations of FGFR3. | Drug | Bioavailability Tablet vs Capsule Formulation, Food Effect Tablet Formulation, Pharmacokinetic Mini-Tablet Formulation, Pharmacokinetic Tablet Formulation |
Primary outcome
Pharmacokinetics single-dose Cmax
Time frame: Up to 48 hours post-dose
maximum plasma concentration (Cmax)
Pharmacokinetics multiple-dose Cmax
Time frame: Up to 24 hours post-dose
maximum steady-state plasma concentration (Cmax)
Pharmacokinetics multiple-dose Cmin
Time frame: Up to 24 hours post-dose
average steady-state trough plasma concentration (Cmin)
Pharmacokinetics single dose Tmax
Time frame: Up to 48 hours post-dose
time to reach maximum plasma concentration (Tmax)
Pharmacokinetics single and multiple dose AUC
Time frame: Up to 48 hours post-dose
area under the plasma concentration-time curve (AUC)
Pharmacokinetics single dose CL/F
Time frame: Up to 48 hours post-dose
apparent total clearance (CL/F)
Pharmacokinetics single dose Vz/F
Time frame: Up to 48 hours post-dose
apparent volume of distribution (Vz/F)
Pharmacokinetics single dose t1/2
Time frame: Up to 48 hours post-dose
half-life of TYRA-300
Pharmacokinetics multiple-dose RCmax
Time frame: Up to 24 hours post-dose
accumulation ratio for Cmax (RCmax)
Pharmacokinetics multiple-dose RAUC
Time frame: Up to 24 hours post-dose
accumulation ratio for AUC
2 secondary outcomes
Safety and tolerability
Time frame: Initiation of study treatment up to 7-days post treatment
Safety and tolerability
Time frame: Initiation of study treatment up to 7-days post treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Doug Warner, M.D. study chair
Tyra Biosciences, Inc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TYRA-300-B01 in people with Healthy, run by Tyra Biosciences, Inc at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 26 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetics single-dose Cmax (time frame: Up to 48 hours post-dose). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2025.