Clinical Trial to Evaluate the Safety and Effects of Ethnicity and Food on Pharmacokinetics of YH25448

Study Overview
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Brief Summary
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Clinical trial is to evaluate the effect of ethnicity and food on the pharmacokinetics (how a drug is absorbed, metabolized, distributed and excreted; plasma drug concentration will be measured in this clinical trial) of YH25448, which Yuhan Corporation plans to develop as a therapeutic agent for Non-Small Cell Lung Cancer.

Detailed Description
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This clinical trial will be conducted in healthy Korean and Caucasian volunteers at Seoul National University Hospital (SNUH) Clinical Trial Center. It is expected to take approximately 39 days from the first dosing of Investigational Product until the final follow-up visit. It will be hospitalized twice for 9 nights and 10 days with 21 days of interval, and one visit will be needed for safety evaluation between 14-17 days from the last dosing of the Investigational Product.

Official Title
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An Open-label, Single-dose Phase 1 Clinical Trial to Evaluate the Safety and Effects of Ethnicity and Food on Pharmacokinetics of YH25448 in Healthy Korean and Caucasian Volunteers

Conditions
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Non-Small Cell Lung Cancer

Intervention / Treatment
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* Drug: YH25448 240mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Informed of the investigational nature of this study and voluntarily agree to participate in this study. Subjects with BMI range of ≥18.5 kg/m2 and < 30.0 kg/m2 and weighing ≥ 50 kg Subjects without congenital or chronic diseases within the last 3 years and without pathologic symptoms as determined by medical diagnosis Healthy Korean and Caucasian males who aged ≥ 19 and ≤ 55 years at the time of consent Exclusion Criteria: Clinically significant chronic infection (e.g. AIDS) or clinically significant medical or psychiatric illness Hypotension (SBP ≤ 90 mmHg or DBP ≤ 50 mmHg) or hypertension (SBP ≥ 150 mmHg or DBP ≥ 100 mmHg) A marked baseline prolongation of QTc greater than 450 msec by Bazett's formula Within 14 days prior to the first administration of investigational product, use of prescription drugs or herbal medication, or within 7 days use of any over-the-counter medications

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1<br>YH25448 240mg single dose in korean | Drug: YH25448 240mg<br>* period 1: A single oral dose of YH25448 240 mg an overnight fast period 2: A single oral dose of YH25448 240 mg after a high-fat breakfast<br>* Other names: YH25448;|
| Experimental: Group 2<br>YH25448 240mg single dose in caucasian | Drug: YH25448 240mg<br>* period 1: A single oral dose of YH25448 240 mg an overnight fast period 2: A single oral dose of YH25448 240 mg after a high-fat breakfast<br>* Other names: YH25448;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUClast of YH25448 | Area under the plasma concentration-time curve from zero to the time of the last quantitative concentration (AUC) of YH25448 | 0-192 hrs | 
| Cmax of YH25448 | Area under the plasma concentration-time curve from zero to the time of Maximum plasma concentration (Cmax) of YH25448 | 0-192 hrs | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUCinf of YH25448 | Area under the plasma concentration time curve from zero to infinity (AUC) of YH25448 | 0-192 hrs | 
| Tmax of YH25448 | Time to reach Cmax of YH25448 | 0-192 hrs | 
| t1/2 of YH25448 | Terminal half life (t1/2) of YH25448 | 0-192 hrs | 
| CL/F of YH25448 | The apparent plasma clearance (CL/F) of YH25448 | 0-192 hrs | 
| Vd/F of YH25448 | Apparent Volume of distribution of YH25448 | 0-192 hrs | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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YH25448, Non-Small Cell Lung Cancer