Clinical Trial to Assess Bioequivalence of Lazertinib Between Two Formulations in Healthy Volunteers.

Study Overview
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Brief Summary
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This Clinical Trial is an open, randomized, fasted, single-dose, oral administration 2-sequence, 2-period crossover study to assess bioequivalence of lazertinib between two formulations in healthy adult volunteers. The subjects administer 240mg of lazertinib of different formulations on the fasted status on each period and have a wash-out period for 14-21 days between the first and second period.

Detailed Description
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This clinical trial will be conducted in healthy male volunteers at Seoul National University Hospital (SNUH) Clinical Trial Center. It is expected to take approximately 32 days from the first dosing of Investigational Product until the final follow-up visit. Subjects will be hospitalized twice for 4 nights and 5 days with 7-14 days of wash-out period, 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, Randomized, Fasted, Single-dose, Oral Administration, 2-sequence, 2-period Crossover Study to Assess Bioequivalence of Lazertinib Between Two Formulations in Healthy Adult Volunteers

Conditions
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Healthy Adult Volunteers

Intervention / Treatment
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* Drug: Lazertinib(G001)
* Drug: Lazertinib(G002)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male, over 19 years of age Male participants must agree to use an adequate contraception method from the first to the third month after the last dose. Participants must have a body mass index (BMI) between 18.5 and 30.0 kg/m2, inclusive(BMI = weight/height2), and body weight not less than 50 kg. Subjects without congenital or chronic diseases within the last 3 years and without pathologic symptoms as determined by medical diagnosis. Participants must be healthy on the basis of clinical laboratory tests performed at screening. Informed of the investigational nature of this study and voluntarily agree to participate in this study. Exclusion Criteria: 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. 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 Participants who are planning COVID-19 vaccine within 14 days before the first intake of study drug and to the end of the trials.

Ages Eligible for Study
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Minimum Age: 19 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: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1<br>Participants first received lazertinib(G001) 240mg tablet morning in a fasting state for 1 day. After a washout period of 14 21days, they then received lazertinib(G002) 240mg in a fasting state morning for 1 day. | Drug: Lazertinib(G001)<br>* Current formulation<br>Drug: Lazertinib(G002)<br>* New formulation<br>|
| Experimental: Group 2<br>Participants first received lazertinib(G002) 240mg tablet morning in a fasting state for 1 day. After a washout period of 14 21days, they then received lazertinib(G001) 240mg in a fasting state morning for 1 day. | Drug: Lazertinib(G001)<br>* Current formulation<br>Drug: Lazertinib(G002)<br>* New formulation<br>|

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 - 168 hours | 
| Cmax of YH25448 | Area under the plasma concentration-time curve from zero to the time of Maximum plasma concentration (Cmax) of YH25448 | 0 - 168 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC0-72h of YH25448 | Area under the plasma concentration-time curve from zero to the time of the last quantitative concentration (AUC) of YH25448 | 0 - 72 hours | 
| AUCinf of YH25448 | Area under the plasma concentration time curve from zero to infinity (AUC) of YH25448 | 0 - 168 hours | 
| Tmax of YH25448 | Time to reach Cmax of YH25448 | 0 - 168 hours | 
| t1/2 of YH25448 | Terminal half life (t1/2) of YH25448 | 0 - 168 hours | 
| λz of YH25448 | Terminal rate constant of YH25448 | 0 - 168 hours | 
| CL/F of YH25448 | The apparent plasma clearance (CL/F) of YH25448 | 0 - 168 hours | 
| Vd/F of YH25448 | Apparent Volume of distribution of YH25448 | 0 - 168 hours | 

 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