Healthy Adult Volunteers
Conditions
Keywords
YH25448, Non-Small Cell Lung Cancer
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.
Interventions
DRUGLazertinib(G001)
Current formulation
DRUGLazertinib(G002)
New formulation
Sponsors
Yuhan Corporation
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
19 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Tmax of YH25448 | 0 - 168 hours | Time to reach Cmax of YH25448 |
| 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 |
| CL/F of YH25448 | 0 - 168 hours | The apparent plasma clearance (CL/F) of YH25448 |
| Vd/F of YH25448 | 0 - 168 hours | Apparent Volume of distribution of YH25448 |
| λz of YH25448 | 0 - 168 hours | Terminal rate constant of YH25448 |
| AUCinf of YH25448 | 0 - 168 hours | Area under the plasma concentration time curve from zero to infinity (AUC) of YH25448 |
Countries
South Korea
Outcome results
None listed