A Relative Bioavailability and Food Effect Study of TYRA-300-B01 Capsule and Tablet Formulations in Healthy Adult Participants
- Registration Number
- NCT06006702
- Lead Sponsor
- Tyra Biosciences, Inc
- 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.
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 60
- 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
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Food Effect Tablet Formulation TYRA-300-B01 TYRA-300-B01 single oral dose of tablet in the fed and fasted state Bioavailability Tablet vs Capsule Formulation TYRA-300-B01 TYRA-300-B01 single oral dose of tablet or capsule crossover followed by twice-daily tablet dosing Pharmacokinetic Tablet Formulation TYRA-300-B01 TYRA-300-B01 single oral dose Pharmacokinetic Mini-Tablet Formulation TYRA-300-B01 TYRA-300-B01 multiple-dose mini-tablet formulation
- Primary Outcome Measures
Name Time Method Pharmacokinetics single-dose Cmax Up to 48 hours post-dose maximum plasma concentration (Cmax)
Pharmacokinetics multiple-dose Cmin Up to 24 hours post-dose average steady-state trough plasma concentration (Cmin)
Pharmacokinetics multiple-dose RAUC Up to 24 hours post-dose accumulation ratio for AUC
Pharmacokinetics multiple-dose Cmax Up to 24 hours post-dose maximum steady-state plasma concentration (Cmax)
Pharmacokinetics single dose Tmax Up to 48 hours post-dose time to reach maximum plasma concentration (Tmax)
Pharmacokinetics single and multiple dose AUC Up to 48 hours post-dose area under the plasma concentration-time curve (AUC)
Pharmacokinetics single dose CL/F Up to 48 hours post-dose apparent total clearance (CL/F)
Pharmacokinetics single dose Vz/F Up to 48 hours post-dose apparent volume of distribution (Vz/F)
Pharmacokinetics single dose t1/2 Up to 48 hours post-dose half-life of TYRA-300
Pharmacokinetics multiple-dose RCmax Up to 24 hours post-dose accumulation ratio for Cmax (RCmax)
- Secondary Outcome Measures
Name Time Method Safety and tolerability Initiation of study treatment up to 7-days post treatment Frequency in changes in laboratory parameters and physical signs of toxicity
Trial Locations
- Locations (1)
Nucleus Network
🇦🇺Melbourne, Victoria, Australia