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

• Status: Recruiting
• Trial end date: 2024-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Tyra Biosciences, Inc

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