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

Healthy Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06006702
• Other study ID #: TYR300-102
• Status: Recruiting
• Phase: Phase 1
• Start date: October 16, 2023
• Est. completion date: July 2024

Study information

• Verified date: March 2024
• Source: Tyra Biosciences, Inc
• Contact: Kate Hogg Call
• Phone: (619)728-4805
• Email: TyraClinicalTrials[@]tyra.bio
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: July 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 26 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

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.

Locations

Country	Name	City	State
Australia	Nucleus Network	Melbourne	Victoria

Sponsors (1)

Lead Sponsor	Collaborator
Tyra Biosciences, Inc

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics single-dose Cmax	maximum plasma concentration (Cmax)	Up to 48 hours post-dose
Primary	Pharmacokinetics multiple-dose Cmax	maximum steady-state plasma concentration (Cmax)	Up to 24 hours post-dose
Primary	Pharmacokinetics multiple-dose Cmin	average steady-state trough plasma concentration (Cmin)	Up to 24 hours post-dose
Primary	Pharmacokinetics single dose Tmax	time to reach maximum plasma concentration (Tmax)	Up to 48 hours post-dose
Primary	Pharmacokinetics single and multiple dose AUC	area under the plasma concentration-time curve (AUC)	Up to 48 hours post-dose
Primary	Pharmacokinetics single dose CL/F	apparent total clearance (CL/F)	Up to 48 hours post-dose
Primary	Pharmacokinetics single dose Vz/F	apparent volume of distribution (Vz/F)	Up to 48 hours post-dose
Primary	Pharmacokinetics single dose t1/2	half-life of TYRA-300	Up to 48 hours post-dose
Primary	Pharmacokinetics multiple-dose RCmax	accumulation ratio for Cmax (RCmax)	Up to 24 hours post-dose
Primary	Pharmacokinetics multiple-dose RAUC	accumulation ratio for AUC	Up to 24 hours post-dose
Secondary	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
Secondary	Safety and tolerability	Frequency in changes in laboratory parameters and physical signs of toxicity	Initiation of study treatment up to 7-days post treatment