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

Phase 1

Completed

• Conditions: Healthy Adult Volunteers
• Interventions: Drug: Lazertinib(G001); Drug: Lazertinib(G002)

• Registration Number: NCT05162274
• Lead Sponsor: Yuhan Corporation

Brief Summary

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

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 Timeline

• Study Start: 2021-11-30
• Study First Submitted: 2021-12-06
• Study First Submitted QC: 2021-12-16
• Study First Posted: 2021-12-17
• Primary Completion: 2022-01-14
• Study Completion: 2022-01-14
• Status Verified: 2022-02
• Last Update Submitted: 2024-12-05
• Last Update Posted: 2024-12-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 38

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Group 1	Lazertinib(G002)	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.
Group 1	Lazertinib(G001)	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.
Group 2	Lazertinib(G002)	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.
Group 2	Lazertinib(G001)	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.

Primary Outcome Measures

Name	Time	Method
AUClast of YH25448	0 - 168 hours	Area under the plasma concentration-time curve from zero to the time of the last quantitative concentration (AUC) of YH25448
Cmax of YH25448	0 - 168 hours	Area under the plasma concentration-time curve from zero to the time of Maximum plasma concentration (Cmax) of YH25448

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Seoul National University Hospital Clinical Trial Center; 🇰🇷 Seoul, Korea, Republic of