Ignite Creation Date:
2025-12-25 @ 3:45 AM
Ignite Modification Date:
2025-12-26 @ 2:32 AM
Study NCT ID:
NCT06006702
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-03-26
First Post:
2023-08-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Relative Bioavailability and Food Effect Study of TYRA-300-B01 Capsule and Tablet Formulations in Healthy Adult Participants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-10-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-21', 'studyFirstSubmitDate': '2023-08-17', 'studyFirstSubmitQcDate': '2023-08-17', 'lastUpdatePostDateStruct': {'date': '2025-03-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pharmacokinetics single-dose Cmax', 'timeFrame': 'Up to 48 hours post-dose', 'description': 'maximum plasma concentration (Cmax)'}, {'measure': 'Pharmacokinetics multiple-dose Cmax', 'timeFrame': 'Up to 24 hours post-dose', 'description': 'maximum steady-state plasma concentration (Cmax)'}, {'measure': 'Pharmacokinetics multiple-dose Cmin', 'timeFrame': 'Up to 24 hours post-dose', 'description': 'average steady-state trough plasma concentration (Cmin)'}, {'measure': 'Pharmacokinetics single dose Tmax', 'timeFrame': 'Up to 48 hours post-dose', 'description': 'time to reach maximum plasma concentration (Tmax)'}, {'measure': 'Pharmacokinetics single and multiple dose AUC', 'timeFrame': 'Up to 48 hours post-dose', 'description': 'area under the plasma concentration-time curve (AUC)'}, {'measure': 'Pharmacokinetics single dose CL/F', 'timeFrame': 'Up to 48 hours post-dose', 'description': 'apparent total clearance (CL/F)'}, {'measure': 'Pharmacokinetics single dose Vz/F', 'timeFrame': 'Up to 48 hours post-dose', 'description': 'apparent volume of distribution (Vz/F)'}, {'measure': 'Pharmacokinetics single dose t1/2', 'timeFrame': 'Up to 48 hours post-dose', 'description': 'half-life of TYRA-300'}, {'measure': 'Pharmacokinetics multiple-dose RCmax', 'timeFrame': 'Up to 24 hours post-dose', 'description': 'accumulation ratio for Cmax (RCmax)'}, {'measure': 'Pharmacokinetics multiple-dose RAUC', 'timeFrame': 'Up to 24 hours post-dose', 'description': 'accumulation ratio for AUC'}], 'secondaryOutcomes': [{'measure': 'Safety and tolerability', 'timeFrame': 'Initiation of study treatment up to 7-days post treatment', 'description': 'number of participants with adverse events (AEs), serious adverse events (SAEs), adverse events of special interest (AESIs) as a measure of safety and tolerability'}, {'measure': 'Safety and tolerability', 'timeFrame': 'Initiation of study treatment up to 7-days post treatment', 'description': 'Frequency in changes in laboratory parameters and physical signs of toxicity'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '26 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males or females of non-childbearing potential, between 18 and 55 years of age\n* In good health, determined by no clinically significant findings from medical history, 12-lead electrocardiogram (ECG), vital signs, and clinical laboratory assessments\n* Body mass index (BMI) 18 to 32 kg/m\\^2 (inclusive)\n* Cohorts 1 and 2 ethnicity requirements: none\n* Cohort 3 ethnicity requirements: first- or second-generation Japanese participants\n\nExclusion Criteria:\n\n* Significant history of any hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, immunologic, musculoskeletal disease, or allergic disease (as determined by the Investigator)\n* Any ocular condition likely to increase the risk of eye toxicity\n* Gastrointestinal disorders that will affect oral administration or absorption of TYRA-300-B01\n* Females of child-bearing potential and males who plan to father a child while enrolled in this study'}, 'identificationModule': {'nctId': 'NCT06006702', 'briefTitle': 'A Relative Bioavailability and Food Effect Study of TYRA-300-B01 Capsule and Tablet Formulations in Healthy Adult Participants', 'organization': {'class': 'INDUSTRY', 'fullName': 'Tyra Biosciences, Inc'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'TYR300-102'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Bioavailability Tablet vs Capsule Formulation', 'description': 'TYRA-300-B01 single oral dose of tablet or capsule crossover followed by twice-daily tablet dosing', 'interventionNames': ['Drug: TYRA-300-B01']}, {'type': 'EXPERIMENTAL', 'label': 'Food Effect Tablet Formulation', 'description': 'TYRA-300-B01 single oral dose of tablet in the fed and fasted state', 'interventionNames': ['Drug: TYRA-300-B01']}, {'type': 'EXPERIMENTAL', 'label': 'Pharmacokinetic Tablet Formulation', 'description': 'TYRA-300-B01 single oral dose', 'interventionNames': ['Drug: TYRA-300-B01']}, {'type': 'EXPERIMENTAL', 'label': 'Pharmacokinetic Mini-Tablet Formulation', 'description': 'TYRA-300-B01 multiple-dose mini-tablet formulation', 'interventionNames': ['Drug: TYRA-300-B01']}], 'interventions': [{'name': 'TYRA-300-B01', 'type': 'DRUG', 'description': 'TYRA-300 is an oral, novel potent FGFR 3-selective tyrosine kinase inhibitor that targets tumors that contain activating gene alterations of FGFR3.', 'armGroupLabels': ['Bioavailability Tablet vs Capsule Formulation', 'Food Effect Tablet Formulation', 'Pharmacokinetic Mini-Tablet Formulation', 'Pharmacokinetic Tablet Formulation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3004', 'city': 'Melbourne', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Nucleus Network', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}], 'overallOfficials': [{'name': 'Doug Warner, M.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Tyra Biosciences, Inc'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tyra Biosciences, Inc', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}