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

PHASE1RECRUITING

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.

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Study details:

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.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

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

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Eligibility

Age eligible for study : 26 and older

Healthy volunteers accepted : Yes

Gender eligible for study: All

Things to know

Study dates

Study start: 2023-10-16

Primary completion: 2024-05-01

Study completion finish: 2024-07-01

Study type

TREATMENT

Phase

PHASE1

Trial ID

NCT06006702

Intervention or treatment

DRUG: TYRA-300-B01

Conditions

• Healthy

Condition: Healthy
DRUG: TYRA-300-B01
Melbourne, Victoria, Australia
Sponsor: Tyra Biosciences, Inc

You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.

Are you running this trial? If you're a clinic or sponsor, you can claim this study. Claim or learn more.

Find a site

Closest Location:

Nucleus Network

Research sites nearby

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Nucleus Network
Melbourne, Victoria, Australia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/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.
EXPERIMENTAL: Pharmacokinetic Mini-Tablet Formulation TYRA-300-B01 multiple-dose mini-tablet formulation	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.

What is the study measuring?

Primary outcome

Primary Outcome Measure	Primary Outcome Description	Primary Outcome Time Frame
Pharmacokinetics single-dose Cmax	maximum plasma concentration (Cmax)	Up to 48 hours post-dose
Pharmacokinetics multiple-dose Cmax	maximum steady-state plasma concentration (Cmax)	Up to 24 hours post-dose
Pharmacokinetics multiple-dose Cmin	average steady-state trough plasma concentration (Cmin)	Up to 24 hours post-dose
Pharmacokinetics single dose Tmax	time to reach maximum plasma concentration (Tmax)	Up to 48 hours post-dose
Pharmacokinetics single and multiple dose AUC	area under the plasma concentration-time curve (AUC)	Up to 48 hours post-dose
Pharmacokinetics single dose CL/F	apparent total clearance (CL/F)	Up to 48 hours post-dose
Pharmacokinetics single dose Vz/F	apparent volume of distribution (Vz/F)	Up to 48 hours post-dose
Pharmacokinetics single dose t1/2	half-life of TYRA-300	Up to 48 hours post-dose
Pharmacokinetics multiple-dose RCmax	accumulation ratio for Cmax (RCmax)	Up to 24 hours post-dose
Pharmacokinetics multiple-dose RAUC	accumulation ratio for AUC	Up to 24 hours post-dose

Secondary outcome

Secondary Outcome Measure	Secondary Outcome Description	Secondary Outcome Time Frame
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	Initiation of study treatment up to 7-days post treatment
Safety and tolerability	Frequency in changes in laboratory parameters and physical signs of toxicity	Initiation of study treatment up to 7-days post treatment

Frequently Asked Questions

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References

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