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

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Adult Volunteers
• Intervention / Treatment: Drug: Lazertinib(G001); Drug: Lazertinib(G002)

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 38
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Seoul National University Hospital Clinical Trial Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1; 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); Current formulation; Drug: Lazertinib(G002); New formulation
Experimental: Group 2; 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); Current formulation; Drug: Lazertinib(G002); New formulation

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Yuhan Corporation
• Investigators: Study Director: Clinical Development and Medical Department, Yuhan Corporation

Study record dates

Study Major Dates

• Study Start (Actual): November 30, 2021
• Primary Completion (Actual): January 14, 2022
• Study Completion (Actual): January 14, 2022

Study Registration Dates

• First Submitted: December 6, 2021
• First Submitted That Met QC Criteria: December 16, 2021
• First Posted (Actual): December 17, 2021

Study Record Updates

• Last Update Posted (Estimated): December 11, 2024
• Last Update Submitted That Met QC Criteria: December 5, 2024
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: Non-Small Cell Lung Cancer; YH25448
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protein Kinase Inhibitors; Lazertinib
• Other Study ID Numbers: YH25448-102

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No