Clinical trial NCT06006702: A Relative Bioavailability and Food Effect Study of TYRA-300-B01 Capsule and Tablet Formulations in Healthy Adult Participants
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Tyra Biosciences, Inc
Sponsor class: INDUSTRY
First posted: 2023-08-23
Enrollment: 60
Sex: ALL
Minimum age (years): 26
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Pharmacokinetics single-dose Cmax
timeFrame: Up to 48 hours post-dose
measure: Pharmacokinetics multiple-dose Cmax
timeFrame: Up to 24 hours post-dose
measure: Pharmacokinetics multiple-dose Cmin
timeFrame: Up to 24 hours post-dose
measure: Pharmacokinetics single dose Tmax
timeFrame: Up to 48 hours post-dose
measure: Pharmacokinetics single and multiple dose AUC
timeFrame: Up to 48 hours post-dose
measure: Pharmacokinetics single dose CL/F
timeFrame: Up to 48 hours post-dose
measure: Pharmacokinetics single dose Vz/F
timeFrame: Up to 48 hours post-dose
measure: Pharmacokinetics single dose t1/2
timeFrame: Up to 48 hours post-dose
measure: Pharmacokinetics multiple-dose RCmax
timeFrame: Up to 24 hours post-dose
measure: Pharmacokinetics multiple-dose RAUC
timeFrame: Up to 24 hours post-dose
Secondary outcomes:
measure: Safety and tolerability
timeFrame: Initiation of study treatment up to 7-days post treatment
measure: Safety and tolerability
timeFrame: Initiation of study treatment up to 7-days post treatment
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: Nucleus Network
state: Victoria
Study officials:
affiliation: Tyra Biosciences, Inc
name: Doug Warner, M.D.
role: STUDY_CHAIR
References: