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A Relative Bioavailability and Food Effect Study of TYRA-300-B01 Capsule and Tablet Formulations 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.
Study details:
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
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 26 and older
Healthy volunteers accepted : Yes
Gender eligible for study: All
Things to know
Study dates
Study start: 2023-10-16
Primary completion: 2024-05-01
Study completion finish: 2024-07-01
Study type
TREATMENT
Phase
PHASE1
Trial ID
NCT06006702
Intervention or treatment
DRUG: TYRA-300-B01
Conditions
- • Healthy
Find a site
Closest Location:
Nucleus Network
Research sites nearby
Select from list below to view details:
Nucleus Network
Melbourne, Victoria, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Participant Group/Arm | Intervention/Treatment |
---|---|
EXPERIMENTAL: Bioavailability Tablet vs Capsule Formulation
| DRUG: TYRA-300-B01
|
EXPERIMENTAL: Food Effect Tablet Formulation
| DRUG: TYRA-300-B01
|
EXPERIMENTAL: Pharmacokinetic Tablet Formulation
| DRUG: TYRA-300-B01
|
EXPERIMENTAL: Pharmacokinetic Mini-Tablet Formulation
| DRUG: TYRA-300-B01
|
What is the study measuring?
Primary outcome
Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
---|---|---|
Pharmacokinetics single-dose Cmax | maximum plasma concentration (Cmax) | Up to 48 hours post-dose |
Pharmacokinetics multiple-dose Cmax | maximum steady-state plasma concentration (Cmax) | Up to 24 hours post-dose |
Pharmacokinetics multiple-dose Cmin | average steady-state trough plasma concentration (Cmin) | Up to 24 hours post-dose |
Pharmacokinetics single dose Tmax | time to reach maximum plasma concentration (Tmax) | Up to 48 hours post-dose |
Pharmacokinetics single and multiple dose AUC | area under the plasma concentration-time curve (AUC) | Up to 48 hours post-dose |
Pharmacokinetics single dose CL/F | apparent total clearance (CL/F) | Up to 48 hours post-dose |
Pharmacokinetics single dose Vz/F | apparent volume of distribution (Vz/F) | Up to 48 hours post-dose |
Pharmacokinetics single dose t1/2 | half-life of TYRA-300 | Up to 48 hours post-dose |
Pharmacokinetics multiple-dose RCmax | accumulation ratio for Cmax (RCmax) | Up to 24 hours post-dose |
Pharmacokinetics multiple-dose RAUC | accumulation ratio for AUC | Up to 24 hours post-dose |
Secondary outcome
Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
---|---|---|
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 |
Safety and tolerability | Frequency in changes in laboratory parameters and physical signs of toxicity | Initiation of study treatment up to 7-days post treatment |
Frequently Asked Questions
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