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

Healthy Adult Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05162274
• Other study ID #: YH25448-102
• Status: Completed
• Phase: Phase 1
• Start date: November 30, 2021
• Est. completion date: January 14, 2022

Study information

• Verified date: February 2022
• Source: Yuhan Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: January 14, 2022
• Est. primary completion date: January 14, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 19 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Adult Volunteers

Intervention

Drug:
• Lazertinib(G001)
Current formulation
• Lazertinib(G002)
New formulation

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital Clinical Trial Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yuhan Corporation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	AUCinf of YH25448	Area under the plasma concentration time curve from zero to infinity (AUC) of YH25448	0 - 168 hours
Secondary	Tmax of YH25448	Time to reach Cmax of YH25448	0 - 168 hours
Secondary	t1/2 of YH25448	Terminal half life (t1/2) of YH25448	0 - 168 hours
Secondary	?z of YH25448	Terminal rate constant of YH25448	0 - 168 hours
Secondary	CL/F of YH25448	The apparent plasma clearance (CL/F) of YH25448	0 - 168 hours
Secondary	Vd/F of YH25448	Apparent Volume of distribution of YH25448	0 - 168 hours